Regulatory Startup Project Coord

At Moffitt Cancer Center, we strive to be the leader in understanding the complexity of cancer and applying these insights to contribute to the prevention and cure of cancer. Our diverse team of over 9,000 are dedicated to serving our patients and creating a workspace where every individual is recognized and appreciated. For this reason, Moffitt has been recognized on the 2023 Forbes list of America's Best Large Employers and America's Best Employers for Women, Computerworld magazine's list of 100 Best Places to Work in Information Technology, DiversityInc Top Hospitals & Health Systems and continually named one of the Tampa Bay Time's Top Workplace. Additionally, Moffitt is proud to have earned the prestigious Magnet designation in recognition of its nursing excellence. Moffitt is a National Cancer Institute-designated Comprehensive Cancer Center based in Florida, and the leading cancer hospital in both Florida and the Southeast. We are a top 10 nationally ranked cancer center by Newsweek and have been nationally ranked by U.S. News & World Report since 1999.

Working at Moffitt is both a career and a mission: to contribute to the prevention and cure of cancer. Join our committed team and help shape the future we envision.

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)

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