REGULATORY STARTUP PROJECT COORD

Moffitt Cancer Center; United States; On-site; USD 63,000 - 97,000; Full time

Job summary

Moffitt Cancer Center is seeking a Regulatory Startup Project Coordinator to shepherd clinical research projects through the study start-up process and ensure activation timelines meet institutional standards.

You will oversee regulatory start-up specialists, develop study documents, and lead problem-solving to keep studies on track while coordinating with study teams and training staff.

Qualifications

• Bachelor’s degree required (Master’s degree preferred).
• Five years’ experience in clinical research (2 of the 5 years must be in a research study start up or regulatory position).
• CCRP/CCRC or equivalent certification preferred.
• Working knowledge of FDA and other regulatory requirements.
• Oncology experience preferred (2 years).
• Strong scientific knowledge and research skills.

Responsibilities

• Oversee progress of study projects through the activation pathway.
• Development of study-related documents for start-up and activation.
• Continuous follow-up with internal and external customers during activation.
• Coordinate with disease-based study teams to schedule activation meetings.
• Provide education to clinical research staff on Study Activation Procedures.
• Ensure systems/spreadsheets are updated with study information.

Skills

Clinical research

Regulatory knowledge

Project coordination

Study activation coordination

Communication

Education

Bachelor’s degree

Master’s degree preferred

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

TheProtocol Review and Regulatory Affairs department is looking for a Regulatory Startup Project Coordinator.

Summary:
The Regulatory Startup Project Coordinator is responsible for shepherding clinical research projects through the study start-up process to ensure activation time-lines meet (or exceed) institutional standards. This position will work with and oversee the activity of study start-up regulatory specialists. They provide leadership in developing study-related documents and problem-solving when issues thatdelay the study activation time-line are encountered.

Essential Job Functions:

• Oversee progress of study projects through the activation pathway at Moffitt Cancer Center.
• Development of study-related documents that are needed for study start-up, so they are available when needed prior to activation.
• Continuous follow‑up with internal and external customers for the duration of the activation process to ensure the timely completion of regulatory‑related tasks.
• Work with disease‑based study teams to schedule study activation meetings and processes to hand off responsibility of the studies.
• Work with Clinical Trials Office training staff to provide new and ongoing education to clinical research staff on Study Activation Procedures.
• Ensure appropriate systems/spreadsheets are updated accurately and compliantly with study information and study dates ensuring other study start‑up regulatory specialists follow established process.
• Create and review Informed Consents drafts in compliance with local requirements and protocol.

Credentials and Qualifications:

• Bachelor’s degree required(Master’s degree preferred)
• Five (5) years’ experience in clinical research (2 of the 5 years must be in a research study start up or regulatory position)
• CCRP/CCRC or equivalent certification preferred
• Working knowledge of Food and Drug Administration and other regulatory requirements
• Strong scientific knowledge and research skills
• Oncology experience preferred(2 years)

Salary Range

$63,377.60 - $96,699.20

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!

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.

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