Located in a historic neighborhood in the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington, D.C., and a commitment to social justice. Our community is a tight knit group of remarkable individuals interested in intellectual inquiry and making a difference in the world.
Georgetown University Medical Center's Office of Research Quality Assurance (ORQA ) promotes overall regulatory compliance to ensure the protection of the rights, welfare, and safety of human research subjects and others at the University. ORQA facilitates the expansion of Georgetown University's robust and growing research enterprise by maximizing the reputation and integrity of Georgetown University through delivery of quality research.
The Quality Assurance Coordinator in the Office of Research Quality Assurance (ORQA) will support the ORQA Director in the implementation of human subject research compliance by coordinating the Data and Safety Monitoring Committees (DSMCs) at GU, and conducting audits and monitoring activities of various DSMCs. Duties include but are not limited to:
Coordinate the DSMC by communicating with the DSMC chair to efficiently run and plan meetings.
Ensure studies that are part of the DSMCs are being monitored as per the risk stratification.
Document auditing activities in writing, using appropriate report formats and communicate such findings to the ORQA Director for dissemination to study teams and any other applicable parties identified by the ORQA Director.
Maintain, in strict confidence, all confidential information regarding research studies and clinical research study team activities and members.
Research websites, journals and government publications to keep abreast of new regulations related to clinical research.
Participate in conducting internal study audits for compliance with institutional and regulatory requirements regarding clinical research.
Review informed consent documents, all source documentation and case report form for adherence to good clinical practice, and other regulatory documents needed for the accurate and compliant implementation of the study protocol and procedures.
Review study related processes to assure adherence with applicable requirements including, but not limited to the approved study protocol, Georgetown University (GU) policies, the approving Institutional Review Board (IRB), applicable Food and Drug Administration (FDA) and other regulatory requirements.
Verify that regulatory files maintained for the study are complete and accurate.
Report any instances of non-compliance discovery in internal audits to the Georgetown University ORQA Director.
Audit data will be shared with ORQA for tracking and reporting purposes.
Demonstrate support for compliance in the performance of job duties and responsibilities by developing and maintaining knowledge of, and performing job functions in compliance with rules, regulations, policies and status that affect his/her job; maintain knowledge of and performing job functions in compliance with GU policies and procedures and wilt report compliance concerns in an appropriate and timely manner.
Bachelor's degree in Health Sciences, Health Systems, or a related field
Strong understanding of FDA, ICH and other regulatory and audit issues in clinical trials and compliance
An understanding of medical terminology and technical writing
Excellent interpersonal communication, including oral and written, required
Must be proficient in Microsoft Office and possess the ability to learn software programs (e.g. IRB, CTMS, EMR)
Two years of clinical research experience or education equivalent, research monitoring experience and/or certification as a CCRA or CCRP
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Georgetown University is an Equal Opportunity/Affirmative Action Employer fully dedicated to achieving a diverse faculty and staff. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex (including pregnancy, gender identity and expression, and sexual orientation) , disability status, protected veteran status, or any other characteristic protected by law.
Internal Number: JR06312
About Georgetown University
Established in 1789, Georgetown is the nation's oldest Catholic and Jesuit University. Georgetown is one of the world's leading academic and research institutions, offering a unique educational experience that prepares the next generation of global citizens to lead and make a difference in the world.