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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.
Protocol Writer I
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 - $48.80Salary 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.
We are committed to maintaining fair and equitable pay practices and regularly review compensation to ensure alignment across our workforce.
1. Equal Employment Opportunity
Moffitt Cancer Center is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, or protected veteran or disabled status. We seek candidates whose skills, and personal and professional experience, have prepared them to contribute to our commitment to diversity and excellence.
2. Reasonable Accommodation
Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Moffitt endeavors to make moffitt.org/careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact one of the Human Resources receptionists by phone at 813-745-7899 or by email at HRReceptionists@moffitt.org. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
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