Similar Jobs
See allClinical Trials Regulatory Specialist III
Emory University
US
IRB
FDA
GCP
Senior Site Navigator
Fortrea
Regulatory
Negotiation
Communication
Research Integrity Specialist - Conflict of Interest
Oregon Health & Science University
US
Compliance
Communication
Analysis
Clinical Research Associate II
Ergomed
Global
Communication
Collaboration
Problem-solving
In-House Clinical Research Associate (Poland)
Alimentiv
Europe
Site Management
Regulatory Compliance
Clinical Research
Position Overview:
- Conduct independent reviews of reliance requests and determine compliance with Cooper policies.
- Work with the Director of HRPP, research leadership, and legal to negotiate and execute IRB reliance agreements.
- Organize, track, and maintain records of all reliance agreements and research activities.
Responsibilities:
- Serve as the primary point of contact for investigators, research staff, external sites and sponsors.
- Coordinate and oversee institutional responsibilities outlined in agreements and dictated by laws and policies.
- Develop policies, procedures, and tools to facilitate the reliance agreement review process.
Additional Tasks:
- Conduct training of investigators and research staff on the use of sIRBs.
- Remain up-to-date on regulations and best practices in the field.
- Assist with regulatory review of human research submitted to the Cooper IRB, as needed.
Cooper University Health Care
Cooper University Health Care is committed to providing extraordinary health care. They are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologies and research protocols.