PROTOCOL WRITER I

PROTOCOL WRITER I

Tampa, FL Job Details Full-time 16 hours ago Qualifications Research design Medical writing Doctor of Medicine Clinical study protocols and reports Clinical research Content editing Mid-level Clinical research compliance Doctor of Pharmacy Bachelor's degree Doctor of Philosophy Scientific protocols Master of Science Master of Arts Research regulatory compliance 1 year

Full Job Description Job 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. 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:

Bachelors 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:

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

Location:

H. Lee Moffitt Cancer Center & Research Institute •

CTO Partnerships Schedule:

Full Time, Day Shift, M-F, 8am-4:30pm