Clinical Research Director Jobs

About The Position

Requirements

• Bachelors (Required)
• 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.
• 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.
• A 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, including at least four (4) years in a leadership or managerial capacity.

Nice To Haves

• 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 preferred.
• Master’s degree in a related field preferred
• Relevant professional certification(s) such as CCRC, CCRP, CHRC, CIP, or equivalent preferred.

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.