Director - Clinical Research Quality Assurance - FT - Days - MHS

The Clinical Research Quality Assurance Director provides strategic and operational oversight of the institution's clinical research quality assurance program, ensuring compliance with federal regulations, Good Clinical Practice (GCP), institutional policies, sponsor requirements, and human research protection standards. This role leads proactive quality and monitoring initiatives, drives continuous improvement, and partners with investigators, research leadership, compliance, IRB, and operational teams to promote research integrity, participant safety, and audit readiness.

Responsibilities

Serves as a key institutional resource during audits, inspections, and accreditation activities, ensuring timely follow-up, risk mitigation, and resolution of findings; Leads and oversees the enterprise clinical research quality assurance and monitoring program, including routine, for-cause, and risk-based reviews; Develops, implements, and maintains QA policies, SOPs, corrective and preventive action (CAPA) processes, and quality improvement initiatives aligned with regulatory and accreditation standards; Monitors evolving federal, state, sponsor, and accreditation requirements such as ICH-GCP E6 updates and ensures timely integration into institutional policies, workflows, and practices; Provides training, education, and strategic guidance to investigators, research staff, and leadership on GCP, FDA, OHRP, HIPAA, and institutional compliance requirements

Requirements

Bachelor's degree (required); Minimum of eight (8) years of progressive core experience in clinical research, human research protections, research compliance, quality assurance, auditing, or related research administration functions; At least four (4) years in a leadership or managerial capacity; In-depth knowledge of federal regulations governing human subjects' research; Demonstrated expertise in FDA regulations, OHRP requirements, ICH-GCP guidelines, HIPAA/privacy regulations, and clinical research quality systems; Requires critical thinking skills, effective communication skills, organization skills, decisive judgment, and the ability to work with minimal supervision; Must be able to work in a stressful environment and take appropriate action

Nice to have

Master's degree in a related field preferred; Bachelor's degree in Healthcare, Nursing, Science, Public Health, or a related field; Prior leadership or management experience overseeing quality assurance, compliance, monitoring, or research operations within an academic medical center, health system, CRO, sponsor, or research institution; Relevant professional certification(s) such as CCRC, CCRP, CHRC, CIP, or equivalent