Sr Research Quality and Compliance Specialist

Baptist Health System, Inc.; United States; Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

Baptist Health System, Inc. in Jacksonville, FL is seeking a dedicated role to guarantee ethical, compliant, and high-quality clinical research across multiple trials.

The position oversees ICH-GCP, FDA/IRB readiness, and institutional regulations, leading audits, CAPA planning, and documentation control while coordinating with clinical teams, sponsors, and regulators to drive quality and operational excellence across the portfolio.

Aufgaben

• Oversee adherence to ICH-GCP, FDA, OHRP, and institutional regulations across trials.
• Lead internal audits and develop CAPA plans.
• Support FDA readiness and ensure protocol and documentation compliance.
• Coordinate patient screening, data collection, and adverse event monitoring.
• Act as liaison with sponsors, regulatory agencies, and institutional partners to promote quality assurance and continuous improvement.

Jobbeschreibung

About Baptist Health

Recognized as a top place to work in health care, Baptist Health cares for more patients in Northeast Florida than any other provider, ranking as “most preferred” for more than 30 years. We’re Jacksonville’s only locally governed, faith‑based, not‑for‑profit health system and provide a full spectrum of preventive and specialty care through 200+ locations and six hospitals. Our centers of excellence include Baptist MD Anderson Cancer Center, Baptist Heart Hospital, Baptist Neurological Institute and Wolfson Children’s Hospital.

The role plays a key role in ensuring ethical, compliant, and high-quality clinical and translational research. This position oversees adherence to ICH‑GCP, FDA, OHRP, and institutional regulations across industry‑sponsored, investigator‑initiated, and NCI‑affiliated trials. The position leads internal audits, develops CAPA plans, supports FDA readiness, and ensures protocol and documentation compliance. Additional responsibilities include 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, this role promotes quality assurance, continuous improvement, and operational excellence across the research portfolio.

Primary Location:

Downtown - BMDA Building1301 Palm AveJacksonville, FL 32207United States of America