Clinical Regulatory Manager
Core
Oversees clinical research regulatory activities for industry-sponsored, NIH, and grant-funded studies, ensuring compliance with federal/state regulations and institutional policies.
Role type
Senior IC clinical regulatory manager
Builds
Regulatory workflows and compliance frameworks for clinical research units
Domain
Healthcare + Clinical Research Regulatory Affairs
Deliverable
client delivery
Required skills
FDA regulations, GCP guidelines, IRB submission processes, Medicare coverage analysis, clinical trial contract management, regulatory policy development, staff training
Preferred skills
ACRP or SOCRA certification, GCP training completion
Technologies
Microsoft Office (Word, Excel), Adobe Acrobat, DocuSign
Responsibilities
Coordinate regulatory submissions and IRB review processes; Support compliance with federal/state regulations and study protocols; Develop and review clinical trial coverage analyses; Facilitate review of clinical trial contracts and budgets; Oversee national clinical trials registry compliance; Develop regulatory policies and procedures; Provide training to clinical research coordinators
Seniority
Senior, hands-on IC
