REGULATORY STARTUP PROJECT COORD

Moffitt Cancer Center; Tampa (FL); On-site; USD 60,000 - 100,000; Full time

Job summary

Join a leading cancer center dedicated to the prevention and cure of cancer as a Regulatory Startup Project Coordinator. This role involves overseeing study projects, ensuring timely completion of regulatory tasks, and collaborating with clinical teams. With a commitment to excellence, this innovative organization offers a supportive environment where your contributions can significantly impact cancer research. Be part of a mission-driven team that is recognized nationally for its dedication to patient care and research advancement.

Qualifications

• 5+ years of clinical research experience, 2+ years in regulatory roles.
• Knowledge of FDA regulations and strong scientific skills.

Responsibilities

• Oversee study projects through the activation pathway.
• Develop and ensure availability of study-related documents.
• Coordinate with teams for activation meetings.

Skills

Regulatory Knowledge

Clinical Research

Scientific Research Skills

Oncology Experience

Education

Bachelor's Degree

Master's Degree

Job description

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 is 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 Times’ 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.

Responsibilities

• Oversee progress of study projects through the activation pathway at Moffitt Cancer Center.
• Develop study-related documents needed for study start-up, ensuring availability prior to activation.
• Follow-up with internal and external stakeholders to ensure timely completion of regulatory tasks.
• Coordinate with disease-based study teams for activation meetings and hand-offs.
• Collaborate with Clinical Trials Office training staff to educate staff on Study Activation Procedures.
• Maintain accurate and compliant updates of study information in systems and spreadsheets.
• Create and review Informed Consent drafts in accordance with local requirements and protocols.

Qualifications

• Bachelor's degree required; Master's degree preferred.
• At least 5 years of experience in clinical research, with 2 years in study start-up or regulatory roles.
• CCRP/CCRC or equivalent certification preferred.
• Knowledge of FDA and other regulatory requirements.
• Strong scientific and research skills.
• Oncology experience preferred, with at least 2 years in the field.