Provides expertise in and works independently to administer IRB regulatory review of all expedited and exempt research protocols. Leads targeted reviews and quality assurance reviews of human subjects research to address IRB-related concerns about compliance with federal and state regulations and internal guidelines. Analyze IRB program performance data to identify and make recommendations for improvement. Develops and leads education programs for principal investigators, clinical research professionals and other research staff about Good Clinical Practices governing human subjects research as well as IRB requirements for research. Develops guidance materials, manuals, templates, job aids and other written and electronic resources on IRB processes and functions. Act as the IRB Reliance Coordinator to facilitate IRB Reliances with collaborating institutions through review of Authorization Agreements.
Be at your best with an organization that equips you to do so. Whose people unite in making lives better. At Carilion Clinic, we help communities stay healthy and our region grow stronger through compassionate care, medical education and research, and neighborhood outreach. As part of our team you can expect professional stability, strong technological resources, and the advancement potential of a regional leader.
Based in Roanoke, VA, we are an award-winning, community-based network of hospitals, primary and specialty physician practices, and affiliations with prestigious academic medical institutions. Explore how joining a regional leader can enhance your ability to learn, grow, and succeed.
Experience: Four years' experience in health care/research/clinical environment and a Bachelor's degree, or two years experience with IRB/ human subjects protection, research compliance, or related experience at a complex healthcare system or setting with a Master's degree. Preferred experience in working with an IRB and/or human subjects research oversight.
Licensure, certification, and/or registration: Possession of Certification as a Certified IRB Professional (CIP) or Certified IRB Manager (CIM), or obtaining CIP within one year of employment.
Other: Knowledge of medical terminology desired. Proficient in the application of federal and state regulations. Must be competent in word processing and spreadsheets. Knowledgeable about data base management systems and statistical software, research methodology, and statistical analysis. Must have effective interpersonal and problem-solving skills. Must be self-directed and excel in attention to detail. Must use good judgment with regard to priorities and deadlines.