Protocol Activation Coordinator, Clinical Trials, FT, 8:00A - 4:30P
About The Position
This role will be a part of the Protocol Activation Core in the Office of Clinical Research across the Baptist Health South Florida (BHSF) system. This core is responsible for ensuring that the portfolio of research successfully progresses through the Institutional and Departmental requirements necessary for full approval and activation while achieving all procedural timelines and metrics. This role will operate under the Protocol Activation Supervisor and will serve as project manager for an assigned study portfolio, providing a high level of technical and regulatory expertise and guidance to research faculty and staff and tumor site teams in accordance with the current Food and Drug Administration (FDA) regulations/guidance and BHSF policy. Must be attentive to detail and able to work collaboratively in a high-volume, multi-tasked environment to achieve goals. Able to provide regulatory guidance to research staff and serve as a mentor to fellow members of the protocol activation team.
Requirements
- Associate's degree.
- Certified Research Contract Professional.
- ACRP Certified Clinical Research Coordinator.
- SOCRA Certified Clinical Research Professional.
- CCB Certified in Healthcare Research Compliance.
- A minimum of 2 years experience in a clinical trial regulatory role or Bachelor‘s degree in lieu of 2 years research experience.
- Research certification (CCRP, CCRC, CRCP or CHRC) required, new employees in this role without certification will have 2 years to obtain research certification.
- 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: 2 Years
Responsibilities
- Serve as project manager for an assigned study portfolio.
- Provide a high level of technical and regulatory expertise and guidance to research faculty and staff and tumor site teams in accordance with the current Food and Drug Administration (FDA) regulations/guidance and BHSF policy.
- Provide regulatory guidance to research staff.
- Serve as a mentor to fellow members of the protocol activation team.
Benefits
- Career growth and development opportunities, with clear pathways and ongoing support
- Comprehensive health and wellness resources that go beyond traditional benefits
- A wellness program that can help employees eliminate their medical plan deductible, reducing out-of-pocket healthcare costs
- Tuition reimbursement to support continued learning and advancement
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
