Research Regulatory Coordinator

Tennessee Oncology•Nashville, TN

17h

About The Position

The Research Regulatory Coordinator provides supportive duties with regulatory best practices. This role is crucial for managing the regulatory aspects of clinical trials within a leading cancer care network.

Requirements

Bachelor’s degree (preferred) in life sciences or equivalent years of service
Working knowledge of medical and pharmaceutical terminology.
Data collection experience
Research knowledge

Responsibilities

Manage, date and distribute all incoming departmental correspondence.
Prepare regulatory file folders, both paper if required and electronic for all new studies.
Prepare initial regulatory packet to Sponsor (signature pages, 1572, CV’s, licenses, laboratory certifications, normal ranges, etc.).
Complete and obtain signatures on Protocols, Amendments and Investigator’s Brochures from appropriate personnel.
Maintain and ensure up-to-date CV’s, licenses, laboratory certifications, normal ranges, etc.
Complete and maintain Financial Disclosure forms for all studies.
Complete and maintain Delegation of Authority Logs and FDA Form 1572.
Prepare, obtain appropriate signatures and maintain Confidentiality Agreements.
Assist in the completion of feasibility questionnaires, in addition to obtaining appropriate data from Investigator and study coordinator.
Set up Pre-Study Visits and Site Initiation Visits including communication, sign-in sheets, ensuring availability of any Investigator or other department staff.
Review Site Initiation Visit binders provided by Sponsors and distribute documents to appropriate team members.
Ensure IRB submission, consent review/changes, IRB correspondence for new and amended protocols.
Maintain IRB required dates for reviews and amendments.
Process IND Safety reports, SUSAR reports and other interim safety reports per SOP.
Prepare for monitor visits by ensuring files prepared and available for questions from monitors, etc.
Process local SAE reports, with assistance from study coordinator/data management team, for regulatory files and submit to IRB.
File protocol specific training documentation for all studies.
Review and file incoming monitor letters.
Correspond outstanding tasks with study coordinators.
Report protocol deviations/waivers to IRB when applicable.
Update Study Tracker as needed.
Communicate with study coordinators about protocol updates/amendments and consent changes.