What are the responsibilities and job description for the Clinical Research Regulatory Specialist - Cardiology - Days position at Integris Health?
INTEGRIS Health, Oklahoma’s largest not-for-profit health system has a great opportunity for a Clinical Research Regulatory Specialist in Oklahoma City, OK. In this position, you’ll work 8a-5p, Full-time, with our Cardiology team providing exceptional care to those who have entrusted INTEGRIS Health with their healthcare needs. If our mission of partnering with people to live healthier lives speaks to you, apply today, and learn more about our increased compensation plans and recently enhanced benefits package for all eligible caregivers such as front-loaded PTO, 100% INTEGRIS Health paid short-term disability, increased retirement match, and paid family leave. We invite you to join us as we strive to be The Most Trusted Partner for Health.
Responsible for conducting pre-reviews of submissions to the Integris Health Institutional Review Board, Heart Center Research, and Cancer Committee. This includes the review of new protocols, continuing reviews, modifications to existing protocols, study closures, emergency use requests, and review of any Unanticipated Problems involving Risks to Subjects or Others. The role works closely with INTEGRIS Health IRB research committees to ensure uniformity of reviews and compliance with the Institutional Review Board (IRB) and regulatory agencies standard operating procedures as well as applicable federal and state regulations. INTEGRIS Health is an Equal Opportunity/Affirmative Action Employer.
- Bachelor's degree in business administration, Education or a related field; Associate degree with 3 years relevant regulatory experience and certification as a clinical research coordinator (CRA, CRC, CRCP or Certificate of Mastery in Clinical Research) OR five years' experience with research regulatory compliance
- Certified IRB Professional (CIP) preferred.
- Must be able to communicate effectively in English (verbal/written)
- And/Or Experience in clinical research compliance, regulatory research and/or operations in the academic or private sector. Experience with submissions to the Institutional Review Board and/or the Federal Drug Administration for Investigational Drugs and Devices (IND/IDE). Knowledgeable of Good Clinical Practice and FDA regulations and procedures. Exemplary organization skills and attention to detail. Proven ability to interpret, analyze, and apply pertinent policies, procedures, regulations, and requirements.
