Clinical Research Protocol Activation Lead

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

Job summary

Baptist Health South Florida seeks a Protocol Activation Core Project Manager within the Office of Clinical Research. You will oversee study portfolios, provide regulatory guidance to faculty and staff, and mentor the protocol activation team to meet FDA and BHSF requirements.

Required are CFR knowledge, clinical research experience, and the ability to interpret complex protocols. This role involves collaboration in a high-volume setting and adherence to timelines.

Qualifications

• Must be able to interpret complex research protocols and regulatory terms.
• Strong working knowledge of CFRs applicable to research (21 CFR Part 11, 50, 54, 56, 312, 314, 812, 814, 45 CFR Part 46, ICH guidelines).
• Experience working with IT systems used for tracking research studies.

Responsibilities

• Serve as project manager for an assigned study portfolio under Protocol Activation Core.
• Provide regulatory guidance to research faculty and staff and mentor team members.
• Ensure research activities progress through FDA regulations and BHSF policies with timely milestones.

Skills

Regulatory guidance

Project management

Clinical research knowledge

Communication

Education

Associates

Tools

Regulatory databases

FDA guidelines

Job description

Baptist Health South Florida seeks a Protocol Activation Core Project Manager within the Office of Clinical Research. You will oversee study portfolios, provide regulatory guidance to faculty and staff, and mentor the protocol activation team to meet FDA and BHSF requirements.

Required are CFR knowledge, clinical research experience, and the ability to interpret complex protocols. This role involves collaboration in a high-volume setting and adherence to timelines.