Careers in Quality

JOB SUMMARYThe Clinical Research Regulatory Specialist supports clinical research activities through the development of protocol-specific documents and reports for research activities from initial submission through study closure. The primary focus for this position is on development, submission, maintenance, filing and reporting of regulatory documents to achieve and maintain compliance with all internal, external and federal policies and regulations pertinent to research involving human subjects. This position also provides regulatory guidance and direction to internal clinical research programs to ensure compliance with all applicable policies, procedures and regulations. ESSENTIAL FUNCTIONS OF THE ROLEPrepares, facilitates and coordinates the