JOB DESCRIPTION: Plans team objectives and responsibilities for a fiscal year training program along with the Director. Oversees the operation and development of online e-learning programs or computer-based virtual courses. Develop KPIs (key performance indicators) for each course and assess feedback for improvement. Provides inspection activities and reports for QA/QI programs in OCR and set targets aimed at improvement for safety, effectiveness, access, and patient-centerdness while developing and managing a comprehensive, risk-based Quality Assurance (QA) program for all aspects of the Office of Clinical Research (OCR) operational and compliance processes. Detect QI/QA problems within the Emory clinical research community to assign tasks to RSCs for resolution. Develops orientation and training programs for incoming, transferring, and exiting investigators by collaborating with the Office for Research Administration Investigator¿s programs. 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. Research 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 reports 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. 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. Works collaboratively and develops effective working relationships with investigators, key study personnel, and OCR staff to accomplish these goals. Facilitates and manages ClinicalTrials.gov activities associated with Emory-sponsored, investigator-initiated research studies. Attends meetings for follow-up on action steps in the absence of the Director. Manages the projects of all RSCs for reporting and updating, as needed.
Performs related responsibilities as required. Responsibilities may include, but are not limited to:
- 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.
- mandatory training of investigators and coordinators conducting FDA-regulated clinical trials at Emory.
MINIMUM QUALIFICATIONS: Master's degree and 7 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. Advanced degree preferred. Certification in Healthcare Research Compliance through the Health Care Compliance Association is strongly preferred within five years of hire. |
Emory is an EEO Employer-Disability/Veteran. Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. |
Human Resources