POSITION SUMMARY:
As a direct report to the Clinical Research Director, the Regulatory Coordinator works closely with research teams across the Department to ensure regulatory compliance and accurate data management collection for multiple cancer trials. The Regulatory Coordinator will work with investigators, study staff, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies to ensure that regulatory requirements for clinical trials are met for Clinical Trials. This position does not involve patient contact, but may include data abstraction from patient records.
ESSENTIAL RESPONSIBILITIES / DUTIES:
-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
-Editing informed consent documents
-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
JOB REQUIREMENTS
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
KNOWLEDGE AND SKILLS:
Excellent written and oral communication skills
Basic knowledge of and ability to operate various computer software applications.
Reference Check required at time of submission
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