What are the responsibilities and job description for the CLINICAL TRIALS AMENDMENT COORDINATOR I position at Moffitt Cancer Center?
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
Job Summary:
The Clinical Trial Amendment Coordinator I (CTAC I) is responsible for reviewing protocol amendments and determine impact on different departments for proper implementation of amendments through all phasesis of the amendment process, in accordance with institutional and industry standards at Moffitt Cancer Center. The CTAC I is expected to work under moderate supervision and direction from the manager to implement varying changes as required by the unique circumstances of each amendment. The CTAC I will perform diverse administrative duties requiring analysis, sound judgment, and knowledge of both protocol life cycle and study conduct. This position has a good understanding of project management and possess strong problem-solving and communication skills. This position develops study-related documents, anticipates potential obstacles to timely and effective amendment implementation and proactively addressing them to avoid delay. This position will interact regularly with various investigators, leaders, and team members within the CTO as well as with other functional areas. This position will interact with study sponsors, vendors, regulatory staff, clinical trial business office, sponsor budgeting and contracting departments. Closely supervised with little latitude for independent judgment during introductory training period. Works under clearly defined guidelines and normally receives detailed instructions on work assignments. Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. Builds stable working relationships. Performs routine assignments using existing procedures. Has conceptual knowledge of theories, practices and procedures acquired through a degree. Develops competence by performing structured work assignments. Receives instruction, guidance and direction from others.
Experience Required
Bachelor's degree with one (1) year of experience in clinical trials (patient facing coordination, data management, regulatory or other research coordination, preferably in oncology).
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
Job Summary:
The Clinical Trial Amendment Coordinator I (CTAC I) is responsible for reviewing protocol amendments and determine impact on different departments for proper implementation of amendments through all phasesis of the amendment process, in accordance with institutional and industry standards at Moffitt Cancer Center. The CTAC I is expected to work under moderate supervision and direction from the manager to implement varying changes as required by the unique circumstances of each amendment. The CTAC I will perform diverse administrative duties requiring analysis, sound judgment, and knowledge of both protocol life cycle and study conduct. This position has a good understanding of project management and possess strong problem-solving and communication skills. This position develops study-related documents, anticipates potential obstacles to timely and effective amendment implementation and proactively addressing them to avoid delay. This position will interact regularly with various investigators, leaders, and team members within the CTO as well as with other functional areas. This position will interact with study sponsors, vendors, regulatory staff, clinical trial business office, sponsor budgeting and contracting departments. Closely supervised with little latitude for independent judgment during introductory training period. Works under clearly defined guidelines and normally receives detailed instructions on work assignments. Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. Builds stable working relationships. Performs routine assignments using existing procedures. Has conceptual knowledge of theories, practices and procedures acquired through a degree. Develops competence by performing structured work assignments. Receives instruction, guidance and direction from others.
Experience Required
Bachelor's degree with one (1) year of experience in clinical trials (patient facing coordination, data management, regulatory or other research coordination, preferably in oncology).
- In lieu of Bachelor's degree an Associate degree plus an additional two (2) years of experience in clinical trials (patient facing coordination, data management, regulatory or other research coordination (preferably in oncology) for a total of three (3) years of experience may be considered.
