Clinical Research Data and Regulatory Coordinator

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.
• Affords assistance to 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.
• 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.

Requirements

• A 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.