Regulatory Affairs Managers handle all regulatory functions for a large portfolio of studies.Â
This includes Institutional Review Board (IRB) approval, all specialty subcommittee reviews, and FDA IND and IDE submission.Â
Regulatory Managers serve as liaisons between principle investigator, co-investigators, sponsoring agents, regulatory agencies, and other members of the research team.
Regulatory Managers lead PIâ™s and study teams in meeting internal and external regulatory compliance requirements, and serve a vital role during study audits.
Partner with PI study team to maximize clinical research efficiency and progress
Consult with PI team regarding strategic planning around clinical research portfolios
Participate in protocol writing
Facilitate study initiation through thoughtful and timely preparation of IRB, sub-committee and FDA submissions
Prepare and maintain all materials related to IRB and FDA approvals
Ensure successful monitoring and auditing of studies including FDA, sponsor and/or internal study audits
Present research portfolio progress during research team meetings
Provide guidance to faculty regarding compliance, funding and research support resources
Maintain a high level of self-education to include review of articles related to clinical research; attend multi-disciplinary conferences; attend workshops specific to clinical research.
Assist in the orientation and training of new and current Clinical Research Support Office staff and/or staff in the various sections of the Department of Medicine.
Plans and executes internal and external audits and activities to support regulatory agency inspections.
Prepares, completes and submits all compliance documentation on a routine basis. Coordinates compliance committee meetings.
Performs other related work as needed.
1-2 years of project management experience.
Regulatory compliance experience.
Clinical research and/or data management experience.
Experience at a large academic or medical institution. Â
Outstanding project management.
Excellent verbal and written communication skills.
Ability to manage stressful situations.
Analytical thinking and problem-solving.
Attention to detail.
Strong organizational skills.
Strong Interpersonal skills.
Work independently with a high degree of initiative.
Work as part of a team.
Ability to maintain confidentiality.
Proficiency with Microsoft Word and Excel.
Proficiency with Adobe Acrobat. Â
Cover Letter (required)
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