COORD STUDY ACTIVATION I in Tampa, Florida at H. Lee Moffitt Cancer Center

Are you looking for an opportunity to be part of an innovative team and make an impact on the lives of those affected by cancer? As a member of the Moffitt Non-Therapeutic Research Office (NTRO) you may interact directly with community members and patients to enroll, educate, and guide participants through the experience of taking part in research. You may support non-therapeutic research in other ways including data entry, project and protocol management and quality assurance. Regardless, you will be a member of a collaborative team that ensures non-therapeutic research activities are moving forward safely, smoothly, and according to plan.

Our NTRO Research team comes from a variety of backgrounds and experiences, including public health, psychology, biological sciences and more. There are opportunities for those who have worked in other areas of public health as well as those who are looking for a new and exciting opportunity. Team members of NTRO work closely with community members, patients, patient families, study sponsors, and clinical teams including physicians, pharmacists, nurses, and other health care providers.

These positions typically offer a Monday through Friday schedule, though some require occasional weekends. Moffitt offers training and orientation.

Position Summary:

The Non-therapeutic Research Office (NTRO) Coordinator Study Activation I (CSA I) is responsible for initiating the startup of non-therapeutic (NTR) research protocols and seeing them through to activation, in accordance with institutional and industry standards at Moffitt Cancer Center. The incumbent is expected to work under moderate supervision and direction from the supervisor, manager, and Principal Investigator to implement NTR research including administrative procedures for the successful conduct of non-therapeutic studies.

This position develops study-related documents, anticipates potential obstacles to activation and pro-actively addressing them to avoid delay. This position will interact with leaders of other functional areas within research administration which are involved in activation processes. This position will interact with study sponsors, vendors, regulatory staff, clinical trial business office, sponsor budgeting and contracting departments.

The Ideal Candidate:

• Establish and maintain effective working relationships with others in a team setting.
• Must have ability to prioritize and pace one's-self when working under the pressure of deadlines and work volume.
• Successfully demonstrates competency by meeting established competency guideline/check list annually.
• Working knowledge of Good Clinical Practice and the policies and regulations necessary for the protection of human subjects and the conduct of non-therapeutic or clinical research.

Responsibilities:

• Manage site qualification and other materials necessary for the activation process (e.g., pre-submission checklists, paperwork, and lab manuals)
• Facilitate and attend team meetings and/or conference calls held periodically during the activation process (e.g., Site Initiation Visits (SIV) and other meetings/conference calls); coordinate with the study team to make arrangements and document minutes.
• Track progress and communicate with multiple key stakeholders, including internal and external customers for the duration of the activation process to ensure timely completion of tasks, including but not limited to Moffitt Shared Resources, Regulatory, Budgets & Contracts and industry sponsors and vendors.
• Create, maintain, and update documents, independently and/or in collaboration with study team
• Ensure all necessary equipment and materials required for study conduct are onsite; Follow-up to ensure study supplies, blood and tissue collection kits, and other materials are received in advance of protocol activation; ensure materials have undergone appropriate review, when necessary.
• Primary liaison for protocol activation for internal and external customers; meets with team regularly to provide progress updates.

Credentials and Qualifications:

• Bachelor’s degree in healthcare, life sciences or relevant degree required with one (1) year of experience in non-therapeutic research or clinical trials (patient facing coordination, data management, regulatory or other research coordination).
  • In lieu of a Bachelor’s degree, an Associate degree and three (3) years experience in non-therapeutic research or clinical trials for a total of 3 years of experience may be considered OR
  • High school diploma and five (5) years experience in non-therapeutic research or clinical trials
• Master’s degree preferred.
• Excellent verbal and written communication skills are required.
• Critical thinking skills, ability to adapt quickly to respond to the needs of the study team.
• Thorough knowledge of word processing (Microsoft Office Suite), data base entry.
• One (1) year experience in clinical trial activation preferred.
• One (1) year experience in oncology preferred.
• Knowledge of project management preferred.
• Knowledge in conducting research procedures and best practices for various types of clinical trials/non-therapeutic (interventional, treatment, observational, biobanking, etc.) preferred.
• Highly skilled in executing and properly conducting research protocols in an academic setting preferred.
• Clinical research certification (e.g., CCRP) preferred.

Moffitt Team Members are eligible for Medical, Dental, Vision, Paid Time Off, Retirement, Parental Leave and more. Tampa is a thriving metropolitan city, which has become a hub for ground-breaking research, welcoming individuals from around the globe. This diverse city is engulfed with rich culture, year-round activities, amazing cuisine and so much more. We strive for work/life balance.

If you have the vision, passion, and dedication to contribute to our mission,

then we have a place for you.