Director - Clinical Research Quality Assurance - FT - Days - MHS
Core
Strategic and operational oversight of the clinical research quality assurance program, ensuring compliance with federal regulations, GCP, and sponsor requirements.
Role type
Director of Clinical Research Quality Assurance
Builds
Enterprise clinical research quality assurance and monitoring program
Domain
Healthcare / Clinical Research Compliance
Required skills
Clinical research quality assurance, GCP compliance, audit management, policy development, CAPA processes, regulatory monitoring, training and education, risk mitigation
Preferred skills
Leadership in academic medical centers, CRO or sponsor experience, relevant certifications (CCRC, CCRP, CHRC, CIP)
Technologies
None stated
Responsibilities
Serve as key institutional resource during audits and inspections; Lead enterprise QA and monitoring program; Develop and maintain QA policies, SOPs, and CAPA processes; Monitor evolving regulatory requirements; Provide training and strategic guidance to investigators and staff
Seniority
Director, strategic and operational leadership