MedStar Health Research Institute is currently looking for an experienced compliance professional to lead our Office of Research Integrity.
In this role, the incumbent directs, and manages ORI staff, departmental activities and successfully leads the integration of department services with other institutional offices and local field operational sites. The incumbent leads the department in the implementation of ethical foundations, federal regulations, regulatory compliance, and relevant Good Clinical Practice (GCP) or other research-excellence standards for all aspects of animal and human research, regardless of discipline, and all standards for the responsible conduct of research.
The incumbent serves as an ORI faculty member for continuing education in research ethics, regulatory compliance, and IRB operations for ORI community constituents. The incumbent has responsibility for the quality improvement, quality assurance, and quality controls for all ORI policies, procedural norms, and standard operating procedures. The incumbent serves as the liaison for MHRI to the Georgetown University Medical Center (GUMC) IRB office and assumes other duties for the successful accomplishment of the ORI mission and its community programs.
The regulatory committees of the Department include the Institutional Review Boards (IRBs), the Institutional Biosafety Committee (IBC), and the Institutional Animal Care and Use Committee (IACUC).
Education: Bachelor’s degree required. Master’s degree preferred. A combination of academic coursework and professional experience may be substituted for academic degree.
Experience: At least 5 years in research administration experience, including IRB, IBC and IACUC highly desirable.
Management: Minimum 3 years in supervision and management of staff. Ability to effectively motivate and supervise others.
IRB: Knowledge of federal regulations such as 21 CFR 50, 56, and 312; 45 CFR 46, 45 CFR 164, etc; all relevant and applicable federal regulations.Must understand and be able to apply ethical, legal and regulatory requirements for the protection of human subjects in research. Understanding of AAHRPP accreditation standards. Knowledge of medical and scientific terminology and research conduct.Previous IRB experience required.
Implementation and follow-up of all tasks associated with responsibilities
Demonstrated proficiency in written and verbal communications
IT: Advanced computer skills, including Microsoft Office, with emphasis on Access, Sharepoint, Excel and Word. Prior experience with ORI IRB/IACUC software preferred.
Ability to use multiple software programs and adapt to different database program
Internal Number: 9581
About MedStar Health Research Institute
MedStar Health Research Institute (MHRI), founded in 1963, is the research division of MedStar Health. MHRI provides scientific, administrative, and regulatory support for clinical research throughout the MedStar Health system. Led by Dr. Neil Weissman, MHRI supports more than 1,000 associates dedicated to advancing health through research.
MHRI’s core services include a biostatistics and epidemiological center, clinical research centers, a research pharmacy, two accredited pre-clinical laboratories, biochemistry and biomarker core laboratories, a core platelet center, a cardiac and vascular pathology center, a genetics/genomics/proteomics research core, a cardiovascular core imaging center, an institutional review board, and an office of research integrity. In the last year, more than 1,000 active studies, involving thousands of patients, resulted in nearly 1,000 peer-reviewed publications. MHRI is in the top 20% of U.S. institutions receiving funds from the National Institutes of Health and other federal agencies, with approximately 60% of its studies being federally funded.
Wherever you look throughout the MedStar Health system, you're likely to find the highly qualified s...cientists and investigators conducting leading edge clinical research. MedStar Health Research Institute researchers cover many areas and types of research. From bench to bedside and into the community, associates across MHRI work to advance the scientific understanding of disease and point the way toward better and more effective treatments. As the research-focused entity of MedStar Health, this is our contribution to the healing work performed throughout the system and in the communities we serve.
Learn more about our Principal Investigators and their research at MedStar Health Research Institute.
If you have any questions about research please contact us at email@example.com.
MedStar Health Research Institute is dedicated to supporting the academic platform of MedStar Health by conducting high quality translational and health sciences research throughout the MedStar system.
To be the trusted leader in caring for people and advancing health.
MedStar Health is a not-for-profit, regional healthcare system with ten hospitals and more than 20 other health-related services in the Maryland and Washington, D.C., region. More than a half-million patients trust their care to MedStar Health each year.