Clinical Research, Sr. Training and Compliance Coordinator
About The Position
The Clinical Research Training and Compliance Coordinator is responsible for developing and overseeing a comprehensive training strategy that supports clinical research operations across medical devices, LDTs, and related programs, ensuring alignment with GCP, FDA, ICH, ISO 14155, and other applicable regulations while promoting inspection readiness and operational excellence. In partnership with Clinical Research Leadership, Study Operations, and Quality Assurance, this role designs and maintains role-based curricula for key functions, supports onboarding and ongoing competency development, and drives continuous improvement of learning programs in alignment with evolving regulations, internal policies, and business initiatives. The position monitors training effectiveness and compliance through defined metrics, identifies and addresses training gaps and competency deficiencies, and maintains inspection-ready documentation to support audits. Additionally, it collaborates with Quality Assurance to align training with SOPs, risk management, and CAPA processes, manages external training vendors, provides subject matter guidance, and fosters a culture of continuous learning and regulatory excellence while ensuring all training activities comply with applicable global standards and organizational policies.
Requirements
- Bachelor's degree in Life Sciences, Biomedical Engineering, Medical Technology, Nursing, Education, or related field or demonstrated experience as evidence of competency
- Minimum of 3 years of experience in clinical research operations, medical devices, or laboratory-developed test (LDT) environments, with demonstrated understanding of regulatory and quality requirements (e.g., GxP, CAP, FDA) and their impact on training design and effectiveness measurement.
- Minimum of 3 years of experience designing, implementing, and evaluating training, learning and development, or competency management programs within a regulated environment (e.g., GxP, CLIA, CAP, FDA).
Benefits
- Excellent Annual Salary + 20% Bonus Potential
- 20 Accrued PTO Days Annually + 10 Paid Holidays
- 401K with 100% Company Match up to 6%
- 3 Health Care Plan Options + Company HSA Contribution
- Company Stock Grant Upon Hire
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
251-500 employees
