PROTOCOL WRITER I

SPEROS; Northern (KY); Hybrid; USD 91,666,000 - 139,832,000; Full time

Job summary

Moffitt Cancer Center in Florida seeks a clinical research Protocol Writer to collaborate with clinical investigators to write, edit and complete clinical trial protocols and related documents for SRC submissions. Under the PI, you will gather technical and scientific materials to conceptualize and deliver proposals.

This role requires deadline-driven organization and ability to manage multiple projects, with 2+ years medical writing experience and a strong background in regulatory documents.

Qualifications

• Bachelor's Degree required.
• Experience in clinical research and medical writing preferred.
• Proven track record in writing high-quality regulatory documents.

Responsibilities

• Write, edit and complete clinical trial protocols and related documents for SRC submissions.
• Collaborate with Clinical Trials Office and PI on study design and documentation.
• Coordinate with external sponsors on protocol development and NIH-defined trials.

Skills

Clinical research writing

Regulatory documentation

Medical writing

Deadline management

Education

Bachelor's Degree

MA/MS/MD/PharmD/PhD with science/clinical experience

Job description

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.

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

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. We are committed to maintaining fair and equitable pay practices and regularly review compensation to ensure alignment across our workforce.

Moffitt Career Site

If you have the vision, passion, and dedication to contribute to our mission, then we have a place for you!

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.

Reasonable Accommodation

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