Regulatory Clinical Research Coordinator - Temp
About The Position
The Regulatory Clinical Research Coordinator position is to support our growing Orthopaedic research program including clinical research coordinators (CRCs) and principal investigators (PIs) with clinical research start-up and regulatory activities. This role is responsible for maintaining regulatory compliance across multiple protocols while supporting research professionals and faculty to ensure studies are conducted efficiently, accurately and in accordance with institutional policies, federal regulations, and Good Clinical Practice ( GCP ). The key responsibilities include preparing, submitting and maintaining regulatory documents for IRB submissions, including initial submissions, amendments, continuing reviews and reportable events, maintaining complete and audit-ready regulatory binders (electronic and/or paper), assisting with investigator documentation (e.g., CVs, licenses, CITI / GCP training records, delegation of authority logs), and supporting study start-up activities including regulatory approvals and site readiness and feasibility.
Requirements
- Comfortable engaging patients via phone conversations
Nice To Haves
- Recruitment experience
Responsibilities
- preparing, submitting and maintaining regulatory documents for IRB submissions, including initial submissions, amendments, continuing reviews and reportable events
- maintaining complete and audit-ready regulatory binders (electronic and/or paper)
- assisting with investigator documentation (e.g., CVs, licenses, CITI / GCP training records, delegation of authority logs)
- supporting study start-up activities including regulatory approvals and site readiness and feasibility
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What This Job Offers
Education Level
No Education Listed
Number of Employees
11-50 employees
