Clinical Research Data and Regulatory Coordinator

OneOncology•Athens, GA

4d•Onsite

About The Position

At University Cancer & Blood Center, we pride ourselves on listening. On providing hope, guidance, and comfort. On getting up each day and striving to make a positive impact on the lives of patients and their families. From our front-desk staff to our counselors, nurses, technicians and physicians – who’ve chosen to accept their calling, we salute them for their efforts and recognize them as the very special individuals that they are. University Cancer & Blood Center has been Northeast Georgia’s leading cancer and hematology treatment center for over 40 years. Our highly skilled medical professionals, whose backgrounds include working at the nation’s leading cancer centers, provide every patient with the most advanced cancer care available in an atmosphere of care and compassion.

Requirements

High school degree or equivalent.
Minimum 2-3 years Medical Office Experience preferred.
The individual must be able to communicate and understand verbal and written English language.
Computer skills a must.

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.