COORD STUDY ACTIVATION I

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.

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.