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JOB DESCRIPTION: - Plans, coordinates, and is accountable for major departmental divisions/sub-units administrative and clinical activities including grants and contracts, budget development and planning for total budgets of $4 million or greater, financial analysis, data processing operations, and human resources management for a division or other department sub-unit with teaching, research and clinical service responsibilities. - Reports directly to the Division or Unit Director and indirectly to the Department Administrator and Chair. - Performs other responsibilities as assigned. MINIMUM QUALIFICATIONS: - A bachelor's degree in business, finance or related science field and five years of professional business or management experience OR an equivalent combination of education, training, and/or experience. - Previous supervisory experience.  PREFERRED QUALIFICATION: - Experience in a clinical setting NOTE: This role will be granted the opportunity to work from home regularly but must be able to commute to Emory University on a flexible weekly schedule based upon business needs.  Schedule is based on agreed upon guidelines of department of work.  Emory reserves the right to change remote work status with notice to employee.
Division
School Of Medicine
Job Number
104833
Campus Location (For Posting) : Location
US-GA-Atlanta
Department
SOM: Emerg Med: Admin
Job Type
Regular Full-Time
Location : Name
Steiner Building Grady Campus
Job Category
Revenue Cycle & Managed Care
Requisition Post Information* : External Company Name
Emory University
OB DESCRIPTION: - Handles or assists with administrative activities generally associated with the conduct of clinical trials. - Maintains data pertaining to research projects, completes source documents/case report forms, and performs data entry. - Assists with patient recruitment. - Attends study meetings. - Orders and maintains equipment and supplies. - Reviews medical records and/or conducts screenings for recruitment of study participants, performs interviews and QOL questionnaires. - Collects study specimen according to protocol which may include phlebotomy, processing, and preparation for shipping. - Coordinates services, schedules procedures, creates and maintains case packages, and monitors charges. - Assists with quality assurance and tracks regulatory submissions. - Performs related approved responsibilities as required. MINIMUM QUALIFICATIONS: (1.) High School Diploma or GED and three years of administrative support experience OR (2.) Two years of college in a scientific, health related, or business administration program and one year of admin support or customer service experience OR (3.) Licensed as a practical nurse (LPN) and one year admin support or one year of licensed practical nursing experience OR (4.) Bachelor's degree, Master's degree, MD or PhD in a scientific, health related or business administration program.   This position is intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of CLINICAL RESEARCHER.   NOTE: Position tasks are required to be performed in-person at an Emory University location; working remote is not an option. Emory reserves the right to change this status with notice to employee.
Division
School Of Medicine
Job Number
104813
Campus Location (For Posting) : Location
US-GA-Atlanta
Department
SOM: Neurology: Cog Neurobehav
Job Type
Regular Full-Time
Location : Name
Executive Park-N Druid Hills
Job Category
Research & Research Administration
Requisition Post Information* : External Company Name
Emory University
JOB DESCRIPTION: - Handles administrative activities generally associated with the conduct of clinical trials. - Provides guidance to less experienced staff. - Manages research project databases, develops flow sheets and other study related documents, and completes source documents/case report forms. - Interfaces with research participants, determines eligibility and consents study participants according to protocol. - Approves orders for supplies and equipment maintenance. - Assists in developing recruitment strategies and conducting screenings for study participants including interviews and questionnaires. - Supervises collection of study specimens and processing. - Establishes case packages for study procedures, monitors scheduling of procedures and charges, coordinates other services as needed. - Ensures compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends monitoring meetings with sponsors. - Prepares regulatory submissions. With appropriate credentialing and training. - May perform phlebotomy or diagnostics. - Performs related approved responsibilities as required. MINIMUM QUALIFICATIONS: (1.) High School Diploma or GED and five years of clinical research experience. OR (2.) Two years of college in a scientific, health related, or business administration program and three years clinical research experience OR (3.) Licensed as a practical nurse (LPN) and two years clinical research experience OR (4.) Bachelor's degree in a scientific, health related, or business administration related program and one year of clinical research experience OR (5.) Master's degree, MD or PhD in a scientific, health related or business administration program   This position is intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of CLINICAL RESEARCHER.   NOTE: Position tasks are generally required to be performed in-person at an Emory University location. Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.
Division
School Of Medicine
Job Number
104808
Campus Location (For Posting) : Location
US-GA-Atlanta
Department
SOM: Medicine: Pulmonary
Job Type
Regular Full-Time
Location : Name
Grady Hospital
Job Category
Research & Research Administration
Requisition Post Information* : External Company Name
Emory University
DEPARTMENT SUMMARY: The Division of Advancement and Alumni Engagement utilizes resources and technology for the purpose of soliciting alumni, donor engagement, donor research, and stewardship throughout Emory University and Health Systems. Our mission is to inspire and steward meaningful, lasting relationships that elevate engagement and giving to fulfill Emory’s mission to serve humanity. The Data Management team creates, maintains, and elevates the AAE database of record through data transfers, data analysis, and data integrity. This team aims to steward data as it aligns with the division's Mission, Vision, and Values (MVV) along with the university's mission. This position will report to the Director of Data Management.   JOB DESCRIPTION: - Collects, compiles and analyzes data. - Performs statistical analysis of data. - Maintains databases and records and generates reports related to analysis. - Assists in presenting results of analyses. ADDITIONAL JOB DETAILS: In addition to the duties outlined above, the Information Analyst II may be required to: - Manage or support the loading and transferring of data between various campus information systems, third-party vendors; CRM and division databases. - Provide data project support and data refinement and enhancement assignments, routine data management, and advise on best practices for data conformity. - Create data/record codes along with managing and monitoring data integrity, including confirming with data entry procedures and standards. - Modify data as required for data conformity to system and division standards and provide guidance for end-users on inputting data.  MINIMUM QUALIFICATIONS: - Bachelor's degree and two years of experience in compiling and analyzing data, or equivalent combination of experience, education, and training. PREFERRED QUALIFICATIONS: - Successful candidates will possess strong organizational, written, and verbal communication skills and possess the ability to manage multiple projects simultaneously. - Strong interpersonal and problem-solving skills with a commitment to excellent customer service, and the ability to work collaboratively. - Experience with various technologies including advanced knowledge and experience with Microsoft Office Suite, mass email applications, relational databases, project management software, PL-SQL Developer and CRM systems. - Possess a high level of professionalism and commitment to confidentiality with sound judgment and discretion. - Prior experience in advancement, fundraising, alumni engagement, non-profit, or a university setting. - Flexibility to accommodate changing priorities and deadlines.  NOTE: This role will be granted the opportunity to work from home regularly but must be able to commute to Emory University on a flexible weekly schedule based upon business needs. Schedule is based on agreed upon guidelines of department of work. Emory reserves the right to change remote work status with notice to employee.
Division
Advancement &Alumni Engagement
Job Number
104807
Campus Location (For Posting) : Location
US-GA-Atlanta
Department
ADV: Resource Advancement
Job Type
Regular Full-Time
Location : Name
Emory Campus-Clifton Corridor
Job Category
Information Technology
Requisition Post Information* : External Company Name
Emory University
JOB DESCRIPTION: - The Clinical Trials Regulatory Specialist I is an entry-level position supporting regulatory affairs in clinical trial research. - The primary focus of the position is to collaborate with the multiple IRBs, sponsoring companies, and site Project Managers to ensure study documents receive committee approval and are made available to the site in a timely manner. - This position will oversee pre-submission to governing agencies, and provide foundational information for more complex regulatory work. - Incumbents in this job classification may be primarily focused on non-interventional studies, with a relatively small trial portfolio. - Duties include: - Assists regulatory team (Regulatory Specialist II and III) in research efforts by facilitating the protocol approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects. - Supports processes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies and procedures and regulations. - Responsible for study completion processes including data lock, study closeout, reporting and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports and assuring archival of appropriate/required documentation - Develops, maintains, utilizes, and updates all internal and external protocols, data collection sheets, spreadsheets, and databases for use in gathering and compiling information specific to each research process. - Knowledgeable of the safety reporting requirements of the study protocol, FDA and other regulatory bodies. In a timely fashion, monitors, detects and reports adverse events meeting requirements of regulatory bodies. - Coordinates activities and gathers information from a variety of sources to achieve stated outcomes - Completes and maintains regulatory documents for all study personnel, including curriculum vitae, license, bio-sketches, financial disclosures, Form FDA 1572, confidentiality agreements, and delegation of duties logs. Performs protocol activation and assist investigators with NCI Registration and Credential Repository (RCR) tasks (i.e. new and renewals) - Reviews initial submissions to determine review category and action to be taken. - Compiles and maintains eRegulatory Binders - Completes submission applications, and other required documentation, prepares protocol specific forms for submission to various review committees, including internal scientific review boards, the IRB and sponsoring entities. - Supports the Assistant Director, Operations Manager, and Regulatory Coordinators II/III in Program Research in the day-to-day activities of regulatory safety management for patients enrolled on research protocols. - Completes protocol renewal applications, amendment applications and maintains record of all adverse event reports. - Attends research team meetings to report on regulatory issues. With department administration, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports to investigators, department administration and funding agencies Performs related responsibilities as required. MINIMUM QUALIFICATIONS: - Bachelor's degree, or an equivalent combination of experience, education and training. Knowledge of clinical research practices. - Must complete all required training courses within one month of hiring date. Preferred Qualifications (optional): Previous Coordinator experience.   NOTE: Position tasks are generally required to be performed in-person at an Emory University location.  Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.
Division
School Of Medicine
Job Number
104805
Campus Location (For Posting) : Location
US-GA-Atlanta
Department
SOM: Psych: Admin
Job Type
Regular Full-Time
Location : Name
Executive Park 12
Job Category
Behavioral Health, Counseling & Clergy
Requisition Post Information* : External Company Name
Emory University
      JOB DESCRIPTION: - Recruits, screens, identifies, contacts, and interviews participants to obtain data for assigned research projects. - Interviews may be conducted in person, in a clinical setting, the subject's residence, or by telephone. - Coordinates the data collection process. May abstract data from the participant's medical record. - Schedules appointments, obtains consent forms, explains the study to the participant and collects data. - May observe participants and record results of observation through written documentation or video recording. - Edits completed questionnaires for completeness, legibility and accuracy. - Follows up with participants to obtain missing data or clarify existing data. - Designs forms, worksheets and study questionnaires. - May code and enter data into a database. Compiles data and produces reports to be used for analysis of research findings. - May monitor blood pressure and heart rate and may take vital signs and height/weight measurements. - May collect blood, saliva, or urine samples from participants and prepare them for laboratory testing. - Provides direction to others engaged in the interviewing process. - Maintains required record-keeping. - Performs related responsibilities as required. MINIMUM QUALIFICATIONS: - A high school diploma or equivalent. - Two years of administrative support, customer service or other related experience which includes one year of interviewing experience. - Data entry experience. Positions that require drawing blood require completion of a phlebotomy training program.   NOTE: Position tasks are generally required to be performed in-person at an Emory University location.  Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.  
Division
School Of Medicine
Job Number
104804
Campus Location (For Posting) : Location
US-GA-Atlanta
Department
SOM: Psych: Child Psych - CAMP
Job Type
Temporary Full-Time
Location : Name
Executive Park-N Druid Hills
Job Category
Laboratory
Requisition Post Information* : External Company Name
Emory University
JOB DESCRIPTION: - Assists in the evaluation and treatment of patients in the Marcus Stroke & Neuroscience Center (ICU) at Grady Memorial Hospital. - Documents the delivery of care in the individual's medical records. - Conducts patient interviews and documents patient histories, psychosocial histories, health status and medical problems or potential problems. - Under the direction of a physician, performs physical examinations and specialized diagnostic and/or therapeutic procedures including cast application and removal, wound suturing and dressing changes. - Assists physician in diagnosing medical problems, developing care plans, and prescribing treatment. - Orders, schedules and/or performs laboratory tests and diagnostic procedures such as urinalyses, pregnancy and blood tests, and x-rays. - Communicates necessity, preparation, nature and anticipated effects of scheduled procedures to patient. In collaboration with physician, arranges for consultations with or referrals to other medical professional or community services. - Educates patient on health habits, self-examinations, behavior management, need for follow-up assessments/treatments, at home medical care, medication and other issues related to medical or health problems. - Works with manager to formulate plan for professional development. - Attends educational in-services as appropriate. - Participates in professional activities and organizations to maintain knowledge of current trends, practices, and developments. - Maintains and updates current, accurate patient records including medical assessment, interventions, and evaluations. - Collects and interprets diagnostic data to implement appropriate care patient care plans. - Prepares statistical reports and analyses of research projects and investigational protocols; reports on progress, adverse trends and appropriate conclusions and recommendations. - Trains and teaches other health care professionals including students and residents in techniques and procedures unique to specific setting. - Actively participates on organizational health services committees. - Performs related responsibilities as required. MINIMUM QUALIFICATIONS: - Completion of an accredited Acute Care Nurse Practitioner program or Physician Assistant program. - Currently licensed as an advanced practice nurse in the state of Georgia by the Georgia Board of Nursing and certified as an Adult Gerontology Acute Care or Acute Care Nurse Practitioner by the American Nurses Credentialing Center (ANCC) or equivalent body or Certified as a Physician's Assistant by the National Commission on Certification of Physician Assistants (NCCPA). - Licensed as appropriate in the state of Georgia - BLS, ACLS, and Healthcare Provider certifications required.   PREFERRED QUALIFICATIONS:    - The ideal candidate would have critical care experience, ideally in the field of Neurology/Critical Care or any other critical care equivalent   NOTE: Position tasks are required to be performed in-person at an Emory University location; working remote is not an option. Emory reserves the right to change this status with notice to employee.
Division
School Of Medicine
Job Number
104802
Campus Location (For Posting) : Location
US-GA-Atlanta
Department
SOM: Neurology: Stroke
Job Type
Regular Full-Time
Location : Name
Grady Hospital
Job Category
Advanced Practice Providers
Requisition Post Information* : External Company Name
Emory University
JOB DESCRIPTION: - Handles administrative activities generally associated with the conduct of clinical trials. - Provides guidance to less experienced staff. - Manages research project databases, develops flow sheets and other study related documents, and completes source documents/case report forms. - Interfaces with research participants, determines eligibility and consents study participants according to protocol. - Approves orders for supplies and equipment maintenance. - Assists in developing recruitment strategies and conducting screenings for study participants including interviews and questionnaires. - Supervises collection of study specimens and processing. - Establishes case packages for study procedures, monitors scheduling of procedures and charges, coordinates other services as needed. - Ensures compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends monitoring meetings with sponsors. - Prepares regulatory submissions. - With appropriate credentialing and training. - May perform phlebotomy or diagnostics. - Performs related approved responsibilities as required. MINIMUM QUALIFICATIONS: (1.) High School Diploma or GED and five years of clinical research experience. OR (2.) Two years of college in a scientific, health related, or business administration program and three years clinical research experience OR (3.) Licensed as a practical nurse (LPN) and two years clinical research experience OR (4.) Bachelor's degree in a scientific, health related, or business administration related program and one year of clinical research experience OR ( 5.) Master's degree, MD or PhD in a scientific, health related or business administration program   This position is intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of CLINICAL RESEARCHER.   NOTE: Position tasks are generally required to be performed in-person at an Emory University location. Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.
Division
Exec.V.P. for Health Affairs
Job Number
104794
Campus Location (For Posting) : Location
US-GA-Atlanta
Department
Winship Clinical Trials
Job Type
Regular Full-Time
Location : Name
North Decatur Bldg
Job Category
Research & Research Administration
Requisition Post Information* : External Company Name
Emory University
JOB DESCRIPTION: - The Senior Administrator, Quality Management (QM) in the Winship Cancer Center is responsible in overseeing operations for the CTO Quality - Management Department ensuring compliance within the guidelines of the Code of Federal Regulations, International Conference on Harmonization, Winship Comprehensive Cancer Institute Services Standard Operating Procedures (SOPs) and is responsible for all aspects of quality. - Oversees the quality management process to ensure all clinical trials meet consistent standards and ensures a collaborative approach to clinical research. - Provides education related to clinical research for CTO staff, other Winship departments and Emory University. - Implements processes that ensure compliance with requirements for grants, contracts and other outside funding agencies. - Promotes an environment that is conducive to professionalism, ongoing advancement and excellence in practice and identifies opportunities for improvement. - Facilitates and assesses process improvement and standardization within Winship CTO, other Emory University departments and/or affiliates to provide for accurate, efficient, timely and cost-effective clinical research and clinical care practices. - Supports processes to ensure compliance with requirements for grants/contracts and other outside funding. - Participates on various Winship committees and in professional organization. - Encourages and facilitates participation in and original research development for CTO staff. - Responsibilities include: Responsible for leading Quality Management (QM) activities for assigned clinical trials programs, including the management of audits, quality issues and investigations, and inspections. - Tracking and evaluates monitoring trends for NCTN trials, FDA inspections, sponsor audits and reporting the trends to Winship CTO Leadership. - Partners with Training/Education and DSMC to ensure monitoring trends are addressed within the clinical trials teams and regulatory and training/competency materials are revised to meet compliance standards. - Provide professional expertise and guidance on Good Clinical Practice (GCP) and applicable regulations to clinical trials teams to proactively identify compliance issues/risks and recommend mitigations. - Liaise with various clinical trials monitors, clinical trials study team, auditors, and investigator to promote a high level of quality and consistency across and within programs; develops the risk-based audit and compliance strategy for assigned programs; assists project teams in implementing corrective and preventive actions; and enables teams to be audit/inspection ready, in support of a culture of sustainable compliance. - Manages internal monitoring and external audits of Winship, documents, databases, or internal systems in compliance with GCP and Winship policies and procedures; assesses impact of audit findings on subject safety, data integrity, and business operations. - Conducts audits requiring advanced auditing skills involving technically complex assignments, including audits of high-risk studies/vendors. - Provides expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned program teams and leadership. - Develops and implements program-specific risk-based audit and compliance strategy and manages audits of sites, documents, databases, or internal systems in compliance with GCP and Winship policies and procedures. - Assesses impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalates compliance risks to Winship CTO management. - Ensures audit reports and corrective actions are developed and completed within timelines mandated in internal procedures. - Facilitates investigations into significant quality issues, scientific misconduct, and serious breach of GCP; facilitates identification of root cause and development of appropriate corrective and preventive actions; tracks actions and confirm effectiveness; ensures reporting of potential or confirmed violations to regulatory authorities. - Assist with management of GCP health authority inspections; lead clinical development teams in preparation for announced audits/inspections and provide GCP compliance technical support during inspections of investigators. - Facilitates appropriate and timely inspection responses and follow-up actions. - Analyzes, reports, and presents metrics for assigned programs to development teams and Winship CTO management; recommends any required actions and monitor implementation. - Escalates systemic and/or critical problems and recommends appropriate solutions to senior management for immediate and long-term resolution. - Performs additional GCP related activities upon request by Winship CTO management. - Ensures compliance with all applicable regulations and timelines for safety case processing and reporting.  - Oversees the CAPA Committee and SOP committee. - Takes on special projects or tasks as required and needed by the Director of the CTO. - Ensures orientation and training policies for investigators comply with local and federal regulations and accreditation standards. - Seeks out new practice methods and principles, applying them to existing clinical research practices. - Assists the program and offices in complying with all accreditations, legal, regulatory, and safety requirements.  - Uses group participation skills when working as a member of a committee or informal work group. - Participates actively and positively on assigned committees. - Accurately identifies opportunities for improvement. - Actively demonstrates facilitative leadership to foster productive teamwork through coaching, mentoring, and counseling. - Other duties as assigned. MINIMUM QUALIFICATIONS: - Bachelor's degree in a related field (scientific, health related or business administration) and seven year's experience in clinical trials management, sponsored research, or regulatory management, including five years of quality management experience - OR an equivalent combination of education and experience. - Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ASCP) certification required within three (3) years of hire. PREFERRED QUALiFICATIONS: - Master's degree with clinical trials experience and at least 2 years GCP-related Quality Assurance or relevant clinical trials experience in NCTN and industry clinical trials. - Strong verbal and written communication skills with the ability to understand and summarize medical terminology. - Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity. - Experience as a clinical manager, operations manager, or general manager. - Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device safety regulations and industry standards. - Experience in indirect management of team members, including assisting in the development, training, and assignment of work/projects to other team members. - Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines. - Experience with good clinical practices and clinical trials development or implementation. - Familiarity with Clinical Trials Monitoring Systems (CTMS). NOTE: This role will be granted the opportunity to work from home regularly but must be able to commute to Emory University on a flexible weekly schedule based upon business needs. Schedule is based on agreed upon guidelines of department of work. Emory reserves the right to change remote work status with notice to employee.   #LI-EMORY005
Division
Exec.V.P. for Health Affairs
Job Number
104772
Campus Location (For Posting) : Location
US-GA-Decatur
Department
Winship Clinical Trials
Job Type
Regular Full-Time
Location : Name
Winship Clairmont Admin Annex
Job Category
Business Operations
Requisition Post Information* : External Company Name
Emory University
JOB DESCRIPTION: - Provides clinical trials monitoring and follows established monitoring processes to support compliance with applicable regulations. - Provides monitoring support for all facets of clinical trials with special emphasis on institutional (investigator-initiated) and Cooperative Group sponsored trials. - Conducts a variety of monitoring activities intended to facilitate and assure that clinical trials comply with the requirements of the approved study protocol, the approving Institutional Review Board, Emory University and applicable Food and Drug Administration (FDA) and other regulatory requirements. - Such activities may include: pre-study resource evaluations, monitoring of ongoing trials, and close-out monitoring of completed trials. - Conducts monitoring activities in accordance with established procedures. Utilizes appropriate monitoring check-lists and report templates to record and report monitoring findings. - Documents monitoring activities in writing, using appropriate report formats and communicates such findings to the appropriate parties (clinical trials management, the principal investigator, and designated members of the regulatory and clinical trials staff.) - Reviews the accuracy, completeness and timeliness of completed study related records, case report forms and other documents. - Compares reported data with original source documents. - Reviews study related processes relative to applicable regulatory requirements, including the FDA's GCP regulations and departmental guidelines. - Reviews drug or device accountability, tracking records, and clinical research pharmacy processes. - Verifies that appropriate storage, supply, usage, instruction, documentation and disposition are in place and followed. - Verifies the following items for clinical trials: protocol compliance (i.e. subject recruitment and eligibility criteria and informed consent procedures); that only designated investigator(s) and/or appropriate clinical research staff are performing clinical trial functions; that regulatory compliance is being maintained (i.e. that investigators are providing and maintaining all study related documents as required.) - Promptly communicates any serious deficiencies noted during monitoring to the appropriate parties. - Works cooperatively with clinical research staff and investigators to address their concerns and to communicate findings that can lead to improved clinical trial performance and/or compliance. - Maintains a record of all correspondence, monitoring reports and other written documentation in accordance with operating procedures. - Participates in meetings and in-service training activities. - Maintains in strict confidence all confidential information regarding clinical trials and clinical research study sponsors. - Promotes a work environment that stresses and demonstrates confidential practices. Follows Emory University and HIPPA compliance policies. - Performs related responsibilities as required. MINIMUM QUALIFICATIONS: - A registered nursing or a bachelor's degree in a related science field. - Three years of clinical research experience which includes one year of monitoring or administering complex clinical trials. - Certification by Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ASCP) is required within three (3) years of hire. - A sound knowledge of ICH and Food and Drug Administration's Good Clinical Practices regulations. - Attention to detail, organizational skills, interpersonal skills, and effective oral and written communication skills. - A knowledge of basic computer programs, such as MSWord and Access. This position is intended for clinical researcher and all clinical training requirements must be tracked through Emory Healthcare under the CLINICAL RESEARCHER for individuals hired in this job classification.   NOTE: This role will be granted the opportunity to work from home regularly but must be able to commute to Emory University on a flexible weekly schedule based upon business needs. Schedule is based on agreed upon guidelines of department of work. Emory reserves the right to change remote work status with notice to employee.
Division
Exec.V.P. for Health Affairs
Job Number
104767
Campus Location (For Posting) : Location
US-GA-Decatur
Department
Winship Clinical Trials
Job Type
Regular Full-Time
Location : Name
Winship Clairmont Admin Annex
Job Category
Laboratory
Requisition Post Information* : External Company Name
Emory University
JOB DESCRIPTION: - Recruits, orients, and supervises research administration staff or independently manages the most complex research administration activities associated with the conduct of clinical trials. - Manages a large or multiple smaller clinical research projects. - Manages clinical trials related information systems. - Supervises the implementation of and adherence to study protocols. - Monitors expenditures and adherence to study budgets and resolves CAS issues. - Educates research staff on established policies, processes and procedures. - Determines effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. - Periodically audits operations including laboratory procedures to ensure compliance with applicable regulations; provides leadership in identifying and implementing corrective actions/processes. - Plans, identifies, and handles study related equipment and facilities needs. - Provides leadership and expertise in identifying and completing research grants, study materials, brochures and correspondence. - Develops and submits grant proposals. - Leads or chairs committees or task forces to address and resolve significant issues. - Performs related approved responsibilities as required. MINIMUM QUALIFICATIONS: (1.) High School Diploma or GED and nine years of clinical research experience. OR (2.) Two years of college in a scientific, health related, or business administration program and seven years clinical research experience OR (3.) Licensed as a Practical Nurse (LPN) and six years clinical research experience OR (4.) Bachelor's degree in a scientific, health related or business administration program and five years of clinical research experience OR (5.) Master's degree, MD or PhD in a scientific, health related, or business administration program and two years of clinical research experience Certified Research Administrator (CRA) or Clinical Research Coordinator (CRC) preferred.   This position is intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of CLINICAL RESEARCHER.
Division
Exec.V.P. for Health Affairs
Job Number
104766
Campus Location (For Posting) : Location
US-GA-Atlanta
Department
Winship Clinical Trials
Job Type
Regular Full-Time
Location : Name
Emory Hospital Midtown
Job Category
Research & Research Administration
Requisition Post Information* : External Company Name
Emory University
JOB DESCRIPTION: - The Senior Administrator, Data Safety and Monitoring Committee (DSMC) at Winship supports and coordinates the Data Safety and Monitoring Committees (DSMC) in following the Winship Data Safety and Monitoring Plan (DSMP). - Responsible for providing quality data in order to respond to the DSMP requirements. - Provides overall support and organization for all committee functions and responsibilities. - Serves as a point of contact activities related to monitoring adherence to DSMP and policies and procedures adopted by Winship Cancer Institute as required by the Cancer Center Support Grant Guidelines (CCSG). - The Senior Administrator, DSMC is responsible for: 1) the preparation of the agenda and review of materials prior to the committee meeting to assure that material required for review are available in accordance with the DSMP; and 2) fulfilling the role of liaison to Committee Chairmen, Program Leaders, Principal Investigators, Regulatory Specialists, and Study Coordinators. - Responsibilities include the following duties: Process, review, and assess SAE, device incident, and pregnancy reports from clients' ongoing drug or device clinical trials in a timely manner. - Responsible for the maintenance, revision and oversight for the Data Safety and Monitoring Plan (DSMP). - Tracking and evaluating monitoring trends for IITs and reporting the trends to Winship CTO Leadership. - Partnering with Training/Education to ensure monitoring trends are addressed within the clinical trials teams and regulatory and training/competency materials are revised to meet compliance standards. - Ensure compliance with all applicable regulations and timelines for safety case processing and reporting. - Responsible for thorough assessment of required data entry elements and timely accurate input of that data into the Clinical Trials Management System (CTMS) to facilitate efficient project management. - This responsibility commences at the original point of project entry, continues through original IRB approval and Activation of the project, and is sustained through periodic monitoring of accuracy and clarity of data elements.  - Independently verifies submitted protocols meet requirements for placement on committee agenda by reviewing submitted form, protocol priority diagrams, and protocols prior to assignment.  - Coordinates and attends Data Safety and Monitoring Committee meetings in accordance with Cancer Center Support Grant guidelines to ensure the success of the Cancer Center's protocol review and monitoring process. - Responsible for compiling agendas, assigning committee reviewers, composing official minutes, and constructing reports and correspondence in final form for Winship review committees, all of which are components essential to the success of the Core Grant. - Prepares DSMC documents in collaboration with the study PI, including confidentiality agreements, conflict of interest statements and charters for each study requiring DSMC review. - Disseminates policy decisions and resolutions to Winship study teams from the Data Safety and Monitoring Committees. - Takes on special projects or tasks as required and needed. - Ensures orientation and training policies for investigators comply with local and federal regulations and accreditation standards. - Seek out new practice methods and principles, applying them to existing clinical research practices.  Assists the program and offices in complying with all accreditations, legal, regulatory, and safety requirements. - Uses group participation skills when working as a member of a committee or informal work group. Participates actively and positively on assigned committees. - Accurately identifies opportunities for improvement.  - Actively demonstrate facilitative leadership to foster productive teamwork through coaching, mentoring, and counseling. - Other duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.   MINIMUM REQUIREMENTS: - Bachelors degree in a related field (scientific or health related) and seven years experience in clinical trials management, sponsored research, or regulatory management, including five years trial or related monitoring experience OR an equivalent combination of education and experience. - Certification by Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ASCP) is required within three (3) years of hire. PREFERRED REQUIREMENTS: - Previous supervisory experience. - Strong verbal and written communication skills with the ability to understand and summarize medical terminology. - Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines. - Experience with good clinical practices and clinical trials development or implementation. - Familiarity with Clinical Trials Monitoring Systems (CTMS). Experience as a clinical manager, operations manager, or general manager. - Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device safety regulations and industry standards. - Experience in indirect management of team members, including assisting in the development, training, and assignment of work/projects to other team members. NOTE: Position tasks are generally required to be performed in-person at an Emory University location.  Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.   #LI-EMORY005
Division
Exec.V.P. for Health Affairs
Job Number
104764
Campus Location (For Posting) : Location
US-GA-Decatur
Department
Winship Clinical Trials
Job Type
Regular Full-Time
Location : Name
Winship Clairmont Admin Annex
Job Category
Business Operations
Requisition Post Information* : External Company Name
Emory University
JOB DESCRIPTION: - Recruits, orients, and supervises research administration staff or independently manages the most complex research administration activities associated with the conduct of clinical trials. - Manages a large or multiple smaller clinical research projects. - Manages clinical trials related information systems. - Supervises the implementation of and adherence to study protocols. - Monitors expenditures and adherence to study budgets and resolves CAS issues. - Educates research staff on established policies, processes and procedures. - Determines effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. - Periodically audits operations including laboratory procedures to ensure compliance with applicable regulations; provides leadership in identifying and implementing corrective actions/processes. - Plans, identifies, and handles study related equipment and facilities needs. - Provides leadership and expertise in identifying and completing research grants, study materials, brochures and correspondence. - Develops and submits grant proposals. - Leads or chairs committees or task forces to address and resolve significant issues. - Performs related approved responsibilities as required. MINIMUM QUALIFICATIONS: (1.) High School Diploma or GED and nine years of clinical research experience. OR (2.) Two years of college in a scientific, health related, or business administration program and seven years clinical research experience OR (3.) Licensed as a Practical Nurse (LPN) and six years clinical research experience OR (4.) Bachelor's degree in a scientific, health related or business administration program and five years of clinical research experience OR (5.) Master's degree, MD or PhD in a scientific, health related, or business administration program and two years of clinical research experience Certified Research Administrator (CRA) or Clinical Research Coordinator (CRC) preferred.   This position is intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of CLINICAL RESEARCHER.   NOTE: Position tasks are generally required to be performed in-person at an Emory University location. Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.    
Division
Exec.V.P. for Health Affairs
Job Number
104761
Campus Location (For Posting) : Location
US-GA-Atlanta
Department
Winship Clinical Trials
Job Type
Regular Full-Time
Location : Name
Emory Hospital Midtown
Job Category
Research & Research Administration
Requisition Post Information* : External Company Name
Emory University
JOB DESCRIPTION: - Under general supervision, performs a variety of defined research and laboratory tests and experiments according to prescribed protocols and assigned schedules. - Sets up experiments as prescribed by a principal investigator. - May be required to participate in laboratory maintenance activities such as sterilization and cleaning of equipment, ordering of supplies, inventory and media preparation. - Maintains records, files and logs of work performed in laboratory notebooks and computer databases. - Compiles data and records results of studies for publications, grants and seminar presentations. - Employees in this classification may be required to work with, take specific precautions against and/or be immunized against potentially hazardous agents. - Performs related responsibilities as required by principal investigator. MINIMUM QUALIFICATIONS: - Bachelor's degree in a scientific field OR equivalent combination of experience, education, and training. NOTE: Position tasks are generally required to be performed in-person at an Emory University location. Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.
Division
School Of Medicine
Job Number
104736
Campus Location (For Posting) : Location
US-GA-Atlanta
Department
SOM: Cell Biology: Admin
Job Type
Regular Full-Time
Location : Name
Emory Campus-Clifton Corridor
Job Category
Laboratory
Requisition Post Information* : External Company Name
Emory University
The successful candidate will join a dynamic team and contribute to multiple virology-focused research projects designed to advance fundamental understanding of viral transmission, genetic diversity and evolution. Training in virological, cell culture and molecular biology techniques will be provided. Experience in these areas or programming would be valuable but is not required.   JOB DESCRIPTION: - Under general supervision, performs a variety of defined research and laboratory tests and experiments according to prescribed protocols and assigned schedules. - Sets up experiments as prescribed by a principal investigator. May be required to participate in laboratory maintenance activities such as sterilization and cleaning of equipment, ordering of supplies, inventory and media preparation. - Maintains records, files and logs of work performed in laboratory notebooks and computer databases. - Compiles data and records results of studies for publications, grants and seminar presentations. Employees in this classification may be required to work with, take specific precautions against and/or be immunized against potentially hazardous agents. - Performs related responsibilities as required by principal investigator. MINIMUM QUALIFICATIONS: - Bachelor's degree in a scientific field OR equivalent combination of experience, education, and training. NOTE: Position tasks are generally required to be performed in-person at an Emory University location. Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.
Division
School Of Medicine
Job Number
104706
Campus Location (For Posting) : Location
US-GA-Atlanta
Department
SOM: Micro/Immun: Admin
Job Type
Regular Full-Time
Location : Name
Emory Campus-Clifton Corridor
Job Category
Laboratory
Requisition Post Information* : External Company Name
Emory University
This position is on the Emory University side of the enterprise and will work in partnership with Emory Healthcare.    Works under the Chief and Deputy Chief Ethics and Compliance Officers to oversee University compliance with federal, state, local, and international laws and regulations regarding privacy and confidentiality of information and data.   JOB DESCRIPTION: - Takes the lead in coordinating, assessing, monitoring, auditing, and reporting on the effectiveness of the University's privacy program. - Identifies and prioritizes information privacy and security risks and develops compliance initiatives in these areas. - Maintains primary oversight of University's program for compliance with HIPAA, FERPA, GDPR and other federal, state, and international laws and University policies regarding information privacy and security. - Oversees GDPR related efforts including policies, procedures, processes for agreements, and training. - Works with campus partners on issues related to FERPA including policies, procedures, and other materials and training. - Works closely with the Emory Healthcare Compliance Office, the University Information Security Officer, and the University Breach Notification Team to coordinate privacy and security compliance efforts, including handling of potential breaches. - Investigates complaints of non-compliance with respect to information privacy and security. - Works with the Institutional Review Board in its capacity as Privacy Board to ensure that policies, processes, and forms for HIPAA compliance are appropriate and up to date. - Assists and facilitates the performance of risk assessments. - As a member of the Office of Ethics and Compliance, also provides support to other non-privacy related ethics and compliance projects as needed. - Performs related responsibilities as required. MINIMUM QUALIFICATIONS: - A bachelor's degree and seven years of professional compliance and/or audit experience, including experience in regulations governing information privacy and confidentiality. - Additional professional certification (e.g., CHRC, CHPP, IAPP, etc.) is highly desirable. - Experience in a compliance role at an institution of higher education or corporation in a highly regulated industry. - Experience with HIPAA, FERPA and GDPR. - Strong analytical and written communication skills. - Significant experience in policy drafting, performing and evaluating risk assessments, and evaluating internal controls and processes in a complex decentralized environment preferred. - Juris Doctorate is preferred. NOTE: This role will be granted the opportunity to work from home regularly but must be able to commute to Emory University on a flexible weekly schedule based upon business needs. Schedule is based on agreed upon guidelines of department of work. Emory reserves the right to change remote work status with notice to employee.                                                                                           #LI-EMORY002
Division
Executive Vice President
Job Number
104693
Campus Location (For Posting) : Location
US-GA-Atlanta
Department
Office of Compliance
Job Type
Regular Full-Time
Location : Name
Emory Campus-Clifton Corridor
Job Category
Laboratory
Requisition Post Information* : External Company Name
Emory University
Emory College’s Learning Design and Online Education program partners with faculty and departments across the Emory College of Arts and Science to provide instructional design support and expertise for all teaching modalities to enhance the student learning experience.  The Instructional Content Developer will play an integral role in supporting the Emory College Learning Design and Online Education team.   JOB DESCRIPTION: - Works with faculty or external constituencies, for example, healthcare and education, to develop instructional materials (both continuing education and/or for university credit) for delivery in traditional face-to-face and/or web/app-based environments. - May research and develop case studies for delivery using novel approaches, including computer and distance learning technologies. - May work in collaboration with multimedia developers. - May assist faculty or external constituents in integrating instructional technologies into their teaching and training. - Evaluates and recommends new instructional methods and associated technology. - May instruct students, faculty, and staff in the selection and use of appropriate instructional methods and associated technologies. - Serves as training facilitator as needed. - Performs related responsibilities as required. ADDITIONAL JOB DETAILS: - Assist with the design, development, and annual updates of instructional content for select high-impact learning opportunities. - Design and develop enhanced multimedia content including the production of asynchronous video and interactive content for the Learning Design and Online Education program and in partnership with ECAS faculty and departments. - Assist with the creation and curation of online content for strategic programs. - Design, develop, maintain, and monitor support resources and document processes for on-campus and online technology needs. - Assist with the development, editing, and general maintenance of ECAS Learning Design and Online Education’s web presence. - Administer workshop, training, and course design program processes such as scheduling trainings and tracking faculty applications, eligibility, completion, and payments for ECAS Learning Design and Online Education programs such as Emory College Online Teaching Strategies (ECOTS), the Continuous Improvement Process (CI), and teaching retreats. - Generate promotional materials for general programming. - Collaborate closely with teams across the Office for Undergraduate Education as well as strategic academic technology partnerships to support the development of learning and instructional content. MINIMUM QUALIFICATIONS: - Bachelor's degree in education or a related field and three years of related experience in an educational environment, OR an equivalent combination of experience, education and training. - The ability to manage multiple projects; strong oral and written communication skills; and the ability to interact with both faculty and staff as part of an interdisciplinary team. - Current knowledge on pedagogical issues related to education and technology. PREFERRED QUALIFICATIONS: - Experience in an academic work setting. - Experience with multimedia content creation. - Experience with video production and post-production. - Able to think creatively and critically and to manage multiple tasks simultaneously and independently. - Must have a keen attention to detail and high customer service skills. - Technically proficient (Microsoft Office suite, able to quickly learn and use Canvas, Articulate 360, Audio and Video Production tools, web development). NOTE: Position tasks are generally required to be performed in-person at an Emory University location.  Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.
Division
Emory College
Job Number
104684
Campus Location (For Posting) : Location
US-GA-Atlanta
Department
ECAS: Ofc Undergrad Education
Job Type
Regular Full-Time
Location : Name
Emory Campus-Clifton Corridor
Job Category
Business Operations
Requisition Post Information* : External Company Name
Emory University
JOB DESCRIPTION: - Assists in managing administrative activities associated with research projects including training and supervision of personnel, grant and budget preparation, data management and statistical analysis and adherence to applicable regulations. - Assists in preparing budgets, monitors expenditures and prepares financial reports. - Manages databases including data collection, coding, analysis and storage. - Assists in developing and submitting grant proposals; monitors grant expenditures and advises principal investigator of changes in reporting or accounting requirements. - Serves as project liaison to other departments, outside organizations, government agencies and product representatives. - Oversees the preparation of operational and statistical reports for management and regulatory agencies. - Ensures project is administered according to research protocol. - May assist in recruiting and interviewing patients/subjects, developing and conducting tests and surveys, gathering or abstracting data or making presentations. - May conduct literature searches and assist with publications. - May supervise staff by orienting, training and giving them ongoing performance feedback. - Performs related responsibilities as required. MINIMUM QUALIFICATIONS: - A bachelor's degree in a science discipline, business management, or related field and two years of related professional experience, or an equivalent combination of experience, education and training. - Note: An approved CAS Exception is required for anyone who is charged to a federal grant or contract under this job code. NOTE: Position tasks are generally required to be performed in-person at an Emory University location.  Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.
Division
School Of Medicine
Job Number
104679
Campus Location (For Posting) : Location
US-GA-Atlanta
Department
SOM: Medicine: Cardiology
Job Type
Regular Full-Time
Location : Name
Emory Campus-Clifton Corridor
Job Category
Laboratory
Requisition Post Information* : External Company Name
Emory University
JOB DESCRIPTION: - Under minimal supervision, performs a variety of specialized and complex research and laboratory tests and procedures. - Uses independent judgment in applying or adapting scientific techniques. - May assist in protocol design. - Investigates and proposes alternative experimental procedures for consideration by a principal investigator. - Assists in planning and scheduling research procedures. - Analyzes and interprets results of studies. - Demonstrates and trains others in the proper use/operation of laboratory techniques and equipment. - Calibrates, troubleshoots and performs routine repair and maintenance of equipment. - Reviews literature for related research developments and techniques and compiles findings. - Monitors laboratory processes to maintain quality assurance standards. - Records results of studies, compiles and analyzes data and prepares charts and graphs. - Monitors the handling, storage and disposal of hazardous substances. - Performs related responsibilities as required. - Employees in this classification may be required to work with, take specific precautions against and/or be immunized against potentially hazardous agents. MINIMUM QUALIFICATIONS: - Bachelor's degree in a scientific field and two years of research experience, or equivalent combination of experience, education, and training. PREFERRED QUALIFICATIONS: - An understanding of molecular biology techniques such as Western Blot, PCR, RNA, histology etc. NOTE: Position tasks are generally required to be performed in-person at an Emory University location.  Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.
Division
School Of Medicine
Job Number
104677
Campus Location (For Posting) : Location
US-GA-Atlanta
Department
SOM: Medicine: Cardiology
Job Type
Regular Full-Time
Location : Name
Emory Campus-Clifton Corridor
Job Category
Laboratory
Requisition Post Information* : External Company Name
Emory University
This position is 100% on-campus. The Division of Animal Resources is seeking to hire a Secretary in our Animal Records group at a Secretary.   JOB DESCRIPTIONS: - Performs routine office and clerical tasks, including but not limited to, greeting visitors, answering and screening phones calls, responding to routine inquiries, maintaining calendars, and preparing daily schedules. - Prioritizes meeting requests for one or more managers and ensures manager is prepared for scheduled meetings. - Coordinates meetings, and may take minutes, summarize and distribute to participants. - Creates and maintains databases and filing systems. - Generates reports, correspondence, and other documents. - Processes incoming and outgoing correspondence. - Orders and maintains office supplies. - May process human resources and payroll transactions. - Performs related responsibilities as required. MINIMUM QUALIFICATIONS:  DB01 Secretary - A high school diploma or equivalent and one year of clerical or secretarial experience. - Previous experience with various personal computer software applications. - Some positions within this classification may require keyboarding skills or knowledge of medical terminology. ADDITIONAL QUALIFICATIONS: - This position provides support of animal records and alignment with animal research protocols, funding sources and animal census. - Provides for documentation of divisional records as well as other clerical and receptionary support as needed. - Requires knowledge of MS Excel, providing reports and metrics related to animal records activity. - Provides for office and phone coverage as assigned. - Required to be on campus. Work will take place in both office and animal facilities. PREFERRED QUALIFICATIONS: - Adept in Excel and Word. Will be working in a database and responsible for pulling data to build reports. - Requires self-starter able to work independently. NOTE: Position tasks are required to be performed in-person at an Emory University location; working remote is not an option. Emory reserves the right to change this status with notice to employee.
Division
School Of Medicine
Job Number
104638
Campus Location (For Posting) : Location
US-GA-Atlanta
Department
SOM: Div of Animal Resources
Job Type
Regular Full-Time
Location : Name
Emory Campus-Clifton Corridor
Job Category
Clerical & Administrative
Requisition Post Information* : External Company Name
Emory University

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