PROTOCOL WRITER I

Working at Moffitt is both a career and a mission: to contribute to the prevention and cure of cancer. As the only National Cancer Institute-designated Comprehensive Cancer Center based in Florida, Moffitt employs some of the best and brightest minds from around the world. Join a dedicated team of nearly 11,000 who are shaping the future we envision. Moffitt has been recognized as a Best and Brightest Company to Work For in the Nation and is continually named one of the Tampa Bay Times’ Top Workplaces.

About the Role

With an emphasis on investigator-initiated, early phase clinical trials, the clinical research Protocol Writer works with clinical investigators to write, edit, and complete clinical trial protocols and related documents necessary to accurately and timely submit clinical trial projects to the Scientific Review Committee (SRC). Works under the direction of the Principal Investigator (PI) to edit, write, and gather technical and scientific documentation required to conceptualize, prepare, and deliver complete clinical protocol proposals to the SRC.

Responsibilities also include working with the Clinical Trials Office to ensure adherence to Moffitt's standards and regulatory requirements and with the PI, working with external sponsors on study design. Secondary responsibilities include supporting clinical science editing activities. For select grants that include clinical trials, the position will work with Grant Administrators on the clinical research portion of the proposal, including developing the protocol and related documents outlined in the PHS Human Subjects and Clinical Trials Information Form as required for NIH defined clinical trials.

Position requires a deadline-driven approach and ability to handle multiple concurrent projects, each with varying deadlines for execution.

Responsibilities

• Write, edit, and complete clinical trial protocols and related documents for submission to the Scientific Review Committee (SRC).
• Work under the direction of the Principal Investigator (PI) to gather technical and scientific documentation.
• Ensure adherence to Moffitt's standards and regulatory requirements in collaboration with the Clinical Trials Office.
• Collaborate with external sponsors on study design.
• Support clinical science editing activities.
• Assist Grant Administrators with the clinical research portion of grant proposals, including developing protocols and related documents for NIH-defined clinical trials.

Requirements

• Bachelor's Degree.
• Strong scientific/medical/health-related background with clinical research experience preferred.

Qualifications

• At least 2 years of relevant medical writing industry experience and a proven track record in writing high-quality regulatory documents.

Preferred Qualifications

• MA, MS, MD, PharmD, or PhD with 1 year of scientific experience and/or clinical research experience.

Pay

Salary Range: $31.99 - $48.80 per hour. Salary ranges posted for this position represent the expected base pay range for the role. Actual compensation may vary based on location and a variety of job-related factors, including experience, skills, education, and internal equity among Team Members in similar positions.