Clinical Research Data and Regulatory Coordinator

University Cancer & Blood Center•Athens, GA

3d•Onsite

About The Position

This role focuses on data entry, regulatory submissions, sponsor interactions, and protocol management and compliance. Daily activities involve detailed administrative, technical, and operational tasks rather than designing experiments or conducting independent scientific investigations. This position is an on-site role and requires employees to work from the office full-time. To ensure regular in-person collaboration and support business needs, only local candidates who currently reside within a reasonable commuting distance of the office will be considered. Candidates must be able to reliably commute to the office each workday and meet all on-site attendance requirements.

Requirements

High school degree or equivalent.
The individual must be able to communicate and understand verbal and written English language.
Computer skills a must.

Nice To Haves

Minimum 2-3 years Medical Office Experience preferred.

Responsibilities

Maintains accurate source documents, regulatory documents, and completion of CRF’s.
Interacts with monitors and manages monitoring visits.
Maintain Regulatory Binder organization.
Maintains and monitors drug temps.
Completes and updates CRF’s/ECRF’s per study requirements accurately.
Follows up with outstanding staff training; ensures appropriate research staff has up-to-date CITI training and IATA training.
Obtained CITI training for GCP and human subjects protection.
Maintains IND safety reports and ensures PI oversight of these documents – documents PI oversight.
Creates, updates, and maintains SOP’s.
Updates and maintains study status log.
Ensures NCI memberships do not expire; submits renewal forms at appropriate timepoints.
Assists data manager in monitoring visits to include updating all regulatory documents and monitor requests for regulatory documents.
Ensures PI reviews monitor follow up letters and addresses/resolves any issues within 2 weeks of monitoring visit.
Updates and maintains master protocol deviation log and ensures PI oversight of all protocol deviations.
Submits protocol deviations, if applicable, to IRB per IRB requirements.
Documents deviations per sponsor request.
Knows and understands regulatory documents (1572, financial disclosure forms, CVs, licenses, IND safety reports).
Submits documents to sponsor within 2 weeks of receipt.
Demonstrates knowledge needed to communicate with IRBs and complete interim review reports in a timely manner.
Ensures regulatory binders are filed correctly and contain up to date information.
Ensures SOP’s are followed with regulatory binders (informed consent tracking log, protocol version tracking log, etc.)
Issues staff training for protocols within 2 weeks of SIV.