Protocol Writer I

Title: Protocol Writer I

Location: Remote

Job Description:

Summary

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.

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

Minimum Requirements:

Bachelor's Degree

Strong scientific/medical/health-related background with clinical research experience preferred.

Experience must include 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.

Salary Range

$31.99 - $48.80

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.