REGULATORY STARTUP PROJECT COORD

Summary

The Protocol 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 that delay 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

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

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 [email protected]. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

Read more information about your EEO rights under the law. 

Transparency in Coverage Rule