DescriptionJob Summary The Senior Research Compliance Specialist is responsible for ensuring adherence to applicable regulatory requirements, institutional policies, and quality standards governing clinical research activities, with a primary focus on industry-sponsored and other externally sponsored studies. This role independently leads internal auditing and preparatory audit activities and serves as the primary liaison for FDA audits and other external regulatory inspections, partnering with study teams to resolve compliance concerns identified during sponsor monitoring visits. The position provides advanced, subject-matter-expert-level compliance guidance, mentors junior compliance staff, and drives continuous quality improvement by identifying compliance risks, coordinating corrective and preventive actions, and partnering with the research education team to maintain audit readiness and regulatory compliance across the research portfolio.
Job Specific Duties - Serves as a senior subject-matter expert for the research team on relevant laws, regulations, and best practices governing industry-sponsored and externally sponsored research.
- Independently plans, conducts, and documents routine, for-cause, and preparatory audits across clinical research studies, with a primary focus on industry-sponsored and externally sponsored trials.
- Evaluates study conduct for compliance with protocols, informed consent requirements, sponsor requirements, regulatory submissions, and institutional policies.
- Reviews informed consent forms, source documents, electronic medical records, case report forms, and regulatory binders for accuracy, completeness, and data integrity.
- Assesses investigator and research staff credentialing, training, and delegation of authority to ensure regulatory, sponsor, and institutional compliance.
- Identifies, analyzes, and classifies audit findings, trends, and systemic risks; escalates significant findings to research leadership.
- Prepares clear, comprehensive audit reports, including recommended corrective and preventive actions (CAPAs).
- Tracks CAPA implementation and effectiveness to ensure timely resolution of compliance issues.
- Leads preparation for, and serves as primary liaison during, FDA audits and other external regulatory inspections; partners with study teams to address non-compliance concerns identified during sponsor monitoring visits.
- Monitors changes in regulatory requirements, including FDA regulations and sponsor/industry standards, and translates new or revised regulations into institutional policies, SOPs, and operational practices.
- Provides compliance guidance, education, and feedback to investigators and research staff to promote audit readiness and quality improvement.
- Mentors and provides guidance to junior compliance staff on audit methodology and regulatory requirements.
- Collaborates with research leadership, quality, and education teams to develop and support continuous quality improvement initiatives.
- Maintains accurate audit records, metrics, and compliance data for reporting and leadership review.
- Communicates findings professionally and effectively, maintaining confidentiality of sensitive and protected information.
Qualifications Minimum Job Requirements - Bachelor's Degree Bachelor's degree in Sciences or Education (OR) 6 years of additional clinical research experience. (Required)
- 7-10 years Clinical Research and/or monitoring or auditing experience, including substantial experience with industry-sponsored and other externally sponsored clinical trials.
- 3-5 years Direct experience in regulatory or compliance auditing/monitoring, including hands-on experience supporting or leading FDA audits, sponsor audits, or other external regulatory inspections.
Knowledge, Skills, and Abilities - CHRC, CCRP, ACRP-CP, or SOCRA Certification.
- Extensive experience with industry-sponsored and externally sponsored (e.g., NIH, cooperative group, foundation) clinical trials.
- Demonstrated experience supporting or leading FDA audits, sponsor audits, and other external regulatory inspections.
- Experience using a Clinical Trials Management System (CTMS) and/or electronic regulatory (e-Reg) system.
- Demonstrated ability to mentor and provide guidance to junior compliance staff.
- Able to maintain confidentiality of sensitive and protected information.
