Regulatory Compliance Specialist
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POST DATE 8/11/2016
END DATE 10/19/2016
JOB DESCRIPTIONJob Summary
Perform study specific regulatory and safety reporting processes across multiple studies in accordance to appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols/plans and process under the direction of the Regulatory Compliance Manager.
DUTIES AND RESPONSIBILITIES:
1. Assure compliance of general and study-specific regulatory and/or safety related processes with SOP`s, FDA, GCP, NIH and applicable regulations.
2. Responsible for assisting in the preparation of research protocols for IRB submission, submitting protocol amendments, preparing renewals, preparing necessary regulatory documents for submission to study sponsors, submits adverse event reports, submits safety reports, notifies IRB of study closures.
3. Build and maintain effective relationships with key study personnel.
4. Work closely with the sponsor and study personnel on relevant regulatory and/or safety issues.
5. Provide routine updates and reporting to the Regulatory Compliance Manager to ensure timely communication regarding status of regulatory and/or important safety related issues.
6. Act as a liaison between the institutional review committees, regulatory agencies, and the investigators to ensure that protocols are approved and that supplementary information is provided in a timely fashion as requested.
7. Maintain the required regulatory files for all clinical trials to ensure regulatory compliance.
8. Maintain regulatory files for monitoring visits and interact with monitors.
9. Maintain archived documents on and off site.
10. May interface with appropriate governmental agency on project/products as identified by the Manager.
11. Maintain a professional and credible image with FDA and other regulatory agencies, Sponsors, vendors, patients and co-workers.
12. Displays ICARE values.
13. Perform other duties as assigned.
Bachelor Degree or 30 hours college coursework preferred.
1 year relevant research program experience.
CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED:
Regulatory Affairs Professionals Society (RAPS), Certified Clinical Research Counselor (CCRC), or Certified Clinical Research Professional (CCRP) is required.
Office and clinic environment. Travel not required.
Equal Employment Opportunity
Houston Methodist is an Equal Opportunity Employer.
Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or other characteristics protected by law.
VEVRAA Federal Contractor priority referral Protected Veterans requested.