Protocol Activation Coordinator, Clinical Trials, FT, 8:00A - 4:30P

Baptist Health; Miami (FL); On-site; USD 61,000 - 80,000; Full time

Job summary

Baptist Health South Florida is seeking a Protocol Activation Core project manager within the Office of Clinical Research. The role provides high-level regulatory guidance to research faculty and staff and coordinates study activation across sites while ensuring compliance with FDA regulations and BHSF policy.

Requires at least 2 years in a clinical trial regulatory role and certification (CCRP/CCRC/CRCP or CHRC). Salary ranges from $61,454 to $79,891 per year, commensurate with experience.

Qualifications

• Minimum 2 years in a clinical trial regulatory role
• Research certification (CCRP, CCRC, CRCP or CHRC) required
• Strong working knowledge of CFR parts 11, 50, 54, 56, 312, 314, 812, 814, 45 CFR Part 46, ICH Guidelines
• Able to interpret complex research protocols quickly and discern terms needed for activation

Responsibilities

• Serve as project manager for an assigned study portfolio and ensure progression through Institutional and Departmental requirements
• Provide regulatory guidance to research staff and mentor protocol activation team members
• Collaborate with FDA-regulated activities and BHSF policy to meet timelines and metrics

Education

Associates

Job description

Baptist Health is the region's largest not-for-profit healthcare organization, with 12 hospitals, over 29,000 employees, 4,500 physicians and 200 outpatient centers, urgent care facilities and physician practices across Miami-Dade, Monroe, Broward and Palm Beach counties. With internationally renowned centers of excellence in cancer, cardiovascular care, orthopedics and sports medicine, and neurosciences, Baptist Health is supported by philanthropy and driven by its faith-based mission of medical excellence. For 26 years, we've been named one of Fortune's 100 Best Companies to Work For, and in the 2025-2026 U.S. News & World Report Best Hospital Rankings, Baptist Health was the most awarded healthcare system in South Florida, earning 63 high-performing honors.

What truly sets us apart is our people. At Baptist Health, we create personal connections with our colleagues that go beyond the workplace, and we form meaningful relationships with patients and their families that extend beyond delivering care. Many of us have walked in our patients' shoes ourselves and that shared experience fuels out commitment to compassion and quality. Our culture is rooted in purpose, and every team member plays a part in making a positive impact - because when it comes to caring for people, we're all in.

Benefits

At Baptist Health, we’re committed to supporting our employees at every stage of their journey, both personally and professionally. Our approach is rooted in a "grow our own" philosophy, designed to help our team members build meaningful, long-term careers with us, supported by benefits that make a real difference, including:

• 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
• And so much more

Together, these benefits and others reflect our commitment to caring for our people, so they can build fulfilling careers with us while making a meaningful impact every day.

Description

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. Estimated salary range for this position is $61454.47 - $79890.81 / year depending on experience.

Qualifications

Degrees:

• Associates.

Licenses & Certifications

• Certified Research Contract Professional.
• ACRP Certified Clinical Research Coordinator.
• SOCRA Certified Clinical Research Professional.
• CCB Certified in Healthcare Research Compliance.

Additional Qualifications

• 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

EOE, including disability/vets