This role is part of the Protocol Activation Core within Clinical Research across the Baptist Health South Florida (BHSF) system. The core is responsible for ensuring that research studies progress through institutional and departmental requirements to achieve full approval and activation, while meeting established timelines and performance metrics. Reporting to the Protocol Activation Supervisor, this role serves as project manager for an assigned study portfolio, providing advanced technical and regulatory expertise and guidance to research faculty, staff, and disease-specific teams in alignment with current Food and Drug Administration (FDA) regulations/guidance and BHSF policies.Estimated salary range for this position is $67811.64 - $88155.13 / year depending on experience.Degrees:
Licenses & Certifications:
- CCB Certified in Healthcare Research Compliance.
- SOCRA Certified Clinical Research Professional.
- ACRP Certified Clinical Research Coordinator.
- Certified Research Contract Professional.
Additional Qualifications:
- Bachelor's degree required.
- A minimum of four years experience in a clinical trial regulatory or protocol activation role.
- Research certification (CCRP, CCRC, CRCP or CHRC) required.
- Able to interpret complex research protocols quickly and discern the explicit and implicit terms needed for activation.
- Strong working knowledge of Code of Federal Regulations applicable to research (e.
- g.
- 21 CFR Part 11, 50, 54, 56, 312, 314, 812, 814, 45 CFR Part 46, ICH Guidelines).
- Must be able to work with and navigate various IT systems used for tracking research studies.
Minimum Required Experience: 4 Years