Clinical Research Compliance Specialist

Job No: 538807
Work Type: Full Time
Location: Main Campus (Gainesville, FL)
Categories: Allied Health, Grant or Research Administration, Health Care Administration/Support, Legal/Audit Services/Compliance
Department:  - HA-UFHCI CRO COMPLIANCE

The UF Health Cancer Institute is the 72nd NCI designated cancer center and the only one at a public university in the State of Florida. As a matrix cancer center, we span all of the University of Florida’s 16 colleges, pulling together a world‑class, multi‑disciplinary membership of over 350 faculty and 150 staff to address the challenges of the cancer burden faced by the population we serve as we work together to find a cure.

As a Clinical Research Compliance Specialist at the UF Health Cancer Institute (UFHCI), you will be responsible for monitoring and auditing clinical trials data to ensure data integrity, protocol compliance, and key regulatory requirements are being followed. Strong understanding of clinical trials coordination, Good Clinical Practice, and the ability to collaborate across multidisciplinary clinical research teams are necessary for success in this role.

• Auditing/monitoring assigned clinical trials and sites, evaluating for compliance with GCP, protocol/regulatory requirements, best practices, and established UFHCI SOPs, documenting and reporting findings, and assisting with the resolution of compliance issues.
• Preparing for and participating in NCI and Sponsor audits according to established schedules, time‑lines, and the request of governing agencies.
• Working with the rest of the Compliance Team and the Compliance Manager to develop and improve the overall QA program for clinical research at the UFHCI including proposing new procedures, amending and drafting policies, creating tracking systems, and other related tasks.
• Liaising with study teams, clinical partners, investigators, sponsors, and other relevant parties to provide insight, guidance, education, and to build/improve relationships between the UFHCI and its compliance partners.

Bachelor’s degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.

$68,000 - $75,000

Home to the University of Florida, one of the nation’s top public universities, Gainesville offers vibrant academic and healthcare communities alongside an affordable cost of living, no state income tax, and mild winters. Enjoy the outdoors with over 30 miles of bike trails, freshwater springs, and numerous water activities, plus easy access to beaches and world‑class theme parks.

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• Bachelor’s degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.

• Bachelor’s degree in Nursing, Health Care, Basic Sciences, or related field.
• Extensive experience with databases and/or subject data.
• Working knowledge of cooperative group clinical trials (with preference for ETCTN and/or NCTN).
• Extensive experience with databases and/or subject data.

• Proven ability to handle confidential information with discretion, be adaptable to various competing demands, and demonstrate the highest level of customer/client service and response.
• Demonstrated ability to establish and maintain effective working relationships with stakeholders and critical staff, both internally and externally, through a variety of communication mediums and venues.
• Project manager mindset and basic skills including: delegation, scheduling, communication, critical thinking, task and quality management, risk management, and flexibility.
• Proficiency with Microsoft Office suite.

Professional clinical research…