Summary

The Senior Quality Assurance and Control Associate provides independent quality oversight of clinical research activities to ensure compliance with FDA regulations, ICH–Good Clinical Practice (ICH-GCP), sponsor requirements, and institutional policies. This role leads and supports internal audits, sponsor audits, and regulatory inspections, including FDA inspections, and ensures the accuracy, completeness, and integrity of clinical study documentation and processes. The position is critical to maintaining continuous audit readiness, identifying and mitigating compliance risks, and supporting the ethical, safe, and compliant conduct of clinical research.

Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay.

Job Duties

Clinical Research Quality Oversight – 50%

• Provide independent, risk-based oversight across a large and diverse clinical study portfolio to ensure compliance with FDA regulations, ICH-GCP, sponsor requirements, and institutional policies.
• Plan, schedule, and conduct routine quality reviews of regulatory documentation, study conduct, source documentation, pharmacy and other study-related materials to support continuous audit readiness and participant safety. • Identify compliance risks, trends, and recurring issues; communicate findings to leadership and key stakeholders.
• Provide guidance to investigators and research staff on corrective and preventative actions (CAPA).
• Support noncompliance management activities, including documentation, escalation as appropriate, and coordination of retraining and process improvements.

Audit and Inspection Management – 30%

• Lead and supports internal audits, sponsor audits, and regulatory inspections, including FDA inspections.
• Coordinate inspection readiness and preparation activities, including documentation reviews, inspection logistics, and staff interview preparation. 
• Document audit/inspection findings clearly and accurately; track issues through resolution.
• Oversee CAPA development, implementation, effectiveness checks, and close-out to ensure timely, sustainable corrective action.

Education, Training, and Continuous Improvement – 20%

• Support and contribute to clinical research education initiatives, including development and delivery of quality and compliance training programs.
• Provide onboarding and investigator training related to GCP, documentation standards, regulatory expectations, and audit preparedness.
• Serve as a quality and regulatory resource to investigators, research staff, and leadership, supporting consistent application of quality standards across CRA and TCRI. 
• Perform other job-related duties as assigned.
   

Minimum Qualifications

• Bachelor's degree.
• Four years of relevant experience.

Preferred Qualifications

• Advanced training in clinical research, regulatory affairs, or quality systems.
• Minimum of four (4) years of experience in clinical research quality assurance, quality control, regulatory compliance, audit oversight, or related functions.
• Demonstrated experience leading or significantly supporting sponsor audits and regulatory inspections, including FDA inspections.
• Strong working knowledge of FDA regulations, ICH–GCP, institutional policies, and sponsor requirements.
• Experience developing and maintaining SOPs, CAPA programs, and risk-based quality oversight frameworks.
• Ability to identify documentation deficiencies, inconsistencies, and process gaps, and implement effective, compliant solutions.
• Ability to independently lead and manage quality reviews and communicate results with appropriate sensitivity and professionalism.
• Excellent written, verbal, and presentation skills, with the ability to communicate effectively with leadership, investigators, research staff, sponsors, and regulatory representatives.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities and deadlines. 
• Demonstrated teamwork and collaboration skills within multidisciplinary environments.