Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the diversity and excellence of our academic community.

The Surgical Critical Cares Initiative (SC2i) team seeks a highly experienced motivated Clinical Trials Regulatory Specialist Sr. Strong knowledge and experience in Regulatory Compliance and Quality Assurance preferred. Improving critical-care decisions can save lives and improve recovery. The Surgical Critical Cares Initiative (SC2i) processes data from participating studies at world-class civilian and military research hospitals to create clinical decision-support tools that focus clinicians on the best choices for each patient. SC2i is focused on developing, translating, and validating biology driven critical care. This model of providing individualized treatment based on the underlying biology has the potential to dramatically improve patient outcomes while reducing costs. Biology driven care enables clinicians to reliably deliver the right treatment at the right time to ensure the best potential outcome at lower cost.

This position will be primarily based at the Emory/Grady site in the department of Surgery (SC2i) at Grady hospital main campus location. The additional job duties are such as but not limited to working closely with the Research Specialist Lead and Research Lab& Clinical Manager in the Quality Assurance Unit in leading activities for Good Clinical Practice, Good Clinical Laboratory Practice, GDAP and CAP Certification.

JOB DESCRIPTION:

• Supports clinical research team (physician-investigators, clinical research staff, nurses, etc.) in research efforts by facilitating the protocol approval process and overseeing documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects.
• Establishes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies and procedures and regulations and guidelines.
• Reviews processes involving regulatory documentation to assure appropriate timelines are followed.
• Researches and analyzes problems and takes a leadership role in resolving.
• Identifies and manages issues and provides feedback to leadership regarding resolution.
• Disseminates information and coordinates or conducts training.
• Reviews documentation of exceptions to compliance standards to assure information is accurate and complete.
• Participates in the development and implementation of standard operating procedures, development and revision of regulatory orientation plans, and orientation and mentorship of newly hired staff.
• Actively participates in designated committees within the unit and Emory University.
• Performs related responsibilities as required. 

MINIMUM QUALIFICATIONS:

• Bachelor's degree and three years of experience in a research environment, or an equivalent combination of experience, education and training.
• Knowledge of IRB processes, federal research regulations and a basic understanding of funding programs and clinical research practices.
• Must obtain all required training courses within one month of hiring date.
• Must possess an applicable research certification.

Emory University is dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, gender, genetic information, age, disability, sexual orientation, gender identity, gender expression, and veteran's status. Emory University does not discriminate in admissions, educational programs, or employment on the basis of any factor stated above or prohibited under applicable law. Students, faculty, and staff are assured of participation in University programs and in the use of facilities without such discrimination. Emory University complies with Executive Order 11246, as amended, Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity and affirmative action. Emory University is committed to achieving a diverse workforce through application of its affirmative action, equal opportunity and nondiscrimination policy in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Inquiries regarding this policy should be directed to the Emory University Department of Equity and Inclusion, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: 404-727-9867 (V) | 404-712-2049 (TDD).
Emory University is committed to providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to request a reasonable accommodation, please contact the Department of Accessibility Services at 404-727-9877 (V) | 404-712-2049 (TDD). Please note that one week advance notice is preferred.