Clinical Research Coordinator

Responsibilities: Schedule and facilitate pre-activation activities including pre-site qualification visits, SIVs, and facility tours Complete feasibility questionnaires for upcoming studies Assist in start-up and implementation activities for new studies Completion and submission of clinical trials amendments to the IRB Correspondence with the IRB, investigators and sponsors throughout the clinical trial process Prepares annual progress reports for IRB renewal of ongoing studies Collection, completion, and submission of regulatory documents to various regulatory entities Maintenance of regulatory binders and other relevant files during the review, approval, and activation process for Clinical Trials Coordinates Review & Processing of Safety Reports to the IRB Manages data collection via chart abstraction and submits data in timely fashion Manages and possibly reports Adverse Events & Deviations reported to the IRB and Sponsors Resolves data discrepancies as requested by Sponsors Participates in monitoring visits as requested by Sponsors and makes data corrections as required by Monitor

Qualifications: EDUCATION: BA/BS required CERTIFICATES, LICENSES, REGISTRATIONS REQUIRED: Human Subject Protections Certification, GCP Certification

EXPERIENCE: Minimum of one year of experience in a research setting Seniority level Associate Employment type Contract Job function Other Industries Pharmaceutical Manufacturing Biotechnology Research Research Services