Clinical Research Protocol Writer

Job Summary

Working remotely in a full-time capacity, the Clinical Research Protocol Writer will collaborate with clinical investigators to write, edit, and finalize clinical trial protocols and related documents necessary for submission to the Scientific Review Committee, ensuring adherence to regulatory requirements and Moffitt's standards.

Key responsibilities

• Write, edit, and complete clinical trial protocols and related documents for investigator-initiated early phase clinical trials
• Collaborate with the Clinical Trials Office and Principal Investigator to ensure compliance with standards and regulatory requirements
• Support clinical science editing activities and assist with the clinical research portion of grant proposals

Required qualifications

• Bachelor's Degree in a relevant field
• At least 2 years of medical writing industry experience with a focus on regulatory documents
• Strong scientific/medical/health-related background with clinical research experience preferred
• Proven track record of producing high-quality documentation
• Ability to manage multiple projects with varying deadlines