Clinical Research Protocol Activation Lead

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 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.