Clinical Research Coordinator A/B

Job Description Summary

This position will assist in the management of multiple clinical trials and responsibilities in specific research area. Coordinate the screening of patients, subject enrollment, collection and storage of biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board (IRB) filings and inquiries, and assist in the preparation of manuscripts, grant proposals, and research related presentations.

Job Responsibilities

CRC-B

• Coordinate and conduct clinical studies, includes; subject recruitment, informed consent, chart maintenance and data entry
• Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines
• Assure compliance with the protocol and regulatory requirements includes: collecting, recording, and maintaining data and source documentations.

CRC-A

• Prepare and process all Institutional Review Board (IRB)through the IRB and other regulatory groups as appropriate including initial submissions, amendments, continuing reviews, adverse events and serious adverse events
• Coordinate, organize and maintain all documentation required by sponsor or CRO