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.
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.
Credentials and Qualifications:
Three (3) years clinical research coordination experience required (regulatory and/or multisite experience preferred).