The Clinical Trials Office (Core Support) is looking for an External Research Coordinator.
- Responsible for assisting in the development and management of multiple research protocols conducted at multiple research sites locally and nationally.
- Will oversee external site participation for the Principal Investigator (PI) in his/her clinical trial(s).
- Create required manuals (e.g., handbook, standard operating procedures) and job aids to assist sites in the proper completion of their required tasks and data entry.
- Coordinating communication and updates between PI's and sites.
- Provides team leadership for projects, administrative tasks, and user support.
- Assists in the audit processes by providing regulatory documentation as requested, developing corrective action plans and providing education as appropriate to correct non-compliance.
- Extensive knowledge of clinical research regulations and processes.
- Strong communication, organizational skills, and self-motivated.
- Detail orientated, ability to problem solve.
- Experience with OnCore.
Credentials and Qualifications:
- Distributes and assists sites in the preparation and submission of required research items for Institutional Review Board (IRB) review, including protocols, consents, amendments, safety reports, and continuing reviews.
- Prepares the protocol specific consent template for distribution to sites and reviews external site's consent prior to submission to IRB.
- Facilitates and participates in regularly scheduled protocol specific teleconferences to discuss adverse events/toxicities, patient safety, and other protocol specific information.
- Conducts monthly quality assessments of the OnCore database for data field omissions and timeliness of data entry. Identifies potential or real regulatory or data management problems of an external/consortium site and communicates to the Manager and/or PI as appropriate.
- Bachelor's degree
- Three (3) years clinical research coordination experience required (regulatory and/or multisite experience preferred).
Please view our website at https://www.moffitt.org/careers-education/