Sr Research Quality and Compliance Specialist
About The Position
This position plays a key role in ensuring ethical, compliant, and high-quality clinical and translational research. It oversees adherence to ICH-GCP, FDA, OHRP, and institutional regulations across industry-sponsored, investigator-initiated, and NCI-affiliated trials. The role leads internal audits, develops CAPA plans, supports FDA readiness, and ensures protocol and documentation compliance. It also supports patient screening, data collection, adverse event monitoring, and coordination with clinical teams to meet trial objectives. As a liaison with sponsors, regulatory agencies, and institutional partners, the position promotes quality assurance, continuous improvement, and operational excellence across the research portfolio.
Responsibilities
- Oversee adherence to ICH-GCP, FDA, OHRP, and institutional regulations across industry-sponsored, investigator-initiated, and NCI-affiliated trials.
- Lead internal audits.
- Develop CAPA plans.
- Support FDA readiness.
- Ensure protocol and documentation compliance.
- Conduct patient screening and data collection.
- Monitor adverse events.
- Coordinate with clinical teams to meet trial objectives.
- Liaise with sponsors, regulatory agencies, and institutional partners.
- Promote quality assurance, continuous improvement, and operational excellence across the research portfolio.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
