Regulatory Coordinator

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.

Position: Regulatory Coordinator

Department: Grants and Funds

Schedule: Full Time

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

(The above statements in this job description are intended to depict the general nature and level of work assigned to the employee(s) in this job. The above is not intended to represent an exhaustive list of accountable duties and responsibilities required).

JOB REQUIREMENTS

EDUCATION:

BA/BS required

CERTIFICATES, LICENSES, REGISTRATIONS REQUIRED:

None

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, including but not limited to Outlook, Word, Excel, and Power Point.
• Strong organizational, attentional to detail and multitasking skills

Equal Opportunity Employer/Disabled/Veterans

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