Research Regulatory Coordinator

Tennessee Oncology • Nashville, TN

1d

About The Position

The Research Regulatory Coordinator provides supportive duties with regulatory best practices.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees