This position may involve the following Health and Safety issues:
Develops and manages a comprehensive, risk-based Quality Assurance (QA) program encompassing all aspects of the Office of Clinical Research (OCR) operational and compliance processes, leading to highly effective and efficient processes designed to ensure data and service quality throughout all OCR teams.
Assists with the optimal application of Federal, State, and local laws, guidance documents, Emory University Institutional policies, and Institutional Review Board (IRB) policies and procedures while meeting the objectives of the Emory University research community.
Consults on complex research and regulatory issues in conjunction with the team(s) to identify solutions and develop improvement processes.
Researches topics of departmental, institutional or strategic importance.
Serves as the central resource for the research community to provide expertise and guidance on complex issues, operational goals, business strategies, ethical considerations, regulatory mandates, and institutional policies related to human research protections.
Develops and facilitates training programs to accomplish goals.
Plans and conducts independent audits to assess compliance with regulations, guidelines, institutional policies, and operating procedures for the purpose of preventing and detecting inaccuracies and mismanagement, while promoting accountability and efficiency within OCR teams.
Prepares and distributes report of findings to the Executive Director and appropriate members of the Leadership Team.
Facilitates and tracks corrective action plans, in support of management, to foster completion and achieve compliance.
Thoroughly reviews complex study protocols and Informed Consent Documents (ICDs) to identify all Emory Healthcare (EHC) and/or Grady billable items and services required of the study which might generate a CPT code that requires a Prospective Reimbursement Analysis (PRA) to ensure research billing compliance.
Reviews Clinical Trial and Applicable Clinical Trial Determination Criteria for studies to ensure compliance with FDA, ICMJE, NIH, and Emory University policies and guidelines.
Facilitates and manages ClinicalTrials.gov activities associated with Emory-sponsored, investigator-initiated research studies.
Responsibilities may include, but are not limited to:
operational functions across all OCR teams to ensure regulatory and institutional compliance with OCR operational functions including timely access to clinically relevant research information for research participants to promote patient safety;
CMS regulations for billing items and services for clinical trials;
budget coverage and recovery of costs for industry-sponsored clinical trials;
FDAAA, NIH, and ICMJE requirements for Emory-Sponsored and Investigator-Initiated research studies;
mandatory training of investigators and coordinators conducting FDA-regulated clinical trials at Emory.
Works collaboratively and develops effective working relationships with investigators, key study personnel, and OCR staff to accomplish these goals.
Performs related responsibilities as required.
Bachelor's degree and 5 years of experience in research administration or a health-related field which includes direct research nurse or clinical research coordinator experience, or equivalent combination of education, training and experience.