Located in the heart of Phoenix, Ariz., St. Joseph's Hospital and Medical Center is a 586-bed, not-for-profit hospital that provides a wide range of health, social and support services with special advocacy for the poor and underserved. St. Joseph's is a nationally recognized center for quality tertiary care, medical education and research. It includes the internationally renowned Barrow Neurological Institute, the Muhammad Ali Parkinson Center, the Norton Thoracic Institute, a campus of Creighton University's Medical School and the first Level I Trauma Center in Arizona verified by the American College of Surgeons. U.S. News & World Report routinely ranks St. Joseph's among the best hospitals in the United States for neurology and neurosurgery. For more information please visit our website at https://www.dignityhealth.org/arizona/locations/stjosephs.
Under the direction of the Arizona Research Integrity & Compliance Officer (RICO), this position involves procedural development of the Responsible Conduct for Research (RCR) quality assurance and improvement (QA/QI program) in compliance with appropriate federal regulations for the implementation of an RCR program for federally funded research.
Responsibilities include curriculum development, deployment and management to ensure proactive education to all research stakeholders on RCR obligations per federal regulations.
This position develops and manages the RCR annual audit plan and conducts audits and investigations with responsibilities to facilitate inquiries into alleged scientific misconduct including adherence to data use agreements (DUA), data management plans and export controls.
Serves as subject matter expert with extensive demonstrated working knowledge of ICH, HHS, AWA, OIG, FDA, OHRP, ICH regulations and GCP guidelines pertaining to the ethical and responsible conduct of research.
This position requires daily operational guidance and a high level of confidentiality upon interaction with all research stakeholders, sponsors, federal and local agencies requiring independent judgement, strong critical thinking skills, and collaboration.
Three to five years of experience in compliance role within the healthcare industry.
Five to seven years of compliance experience within a university, sponsored industry, research institute, or hospital research environment.
Experience with quality assurance review program development and implementation of educational programs.
Experience within the area of biosafety, animal care and use, institutional ethics review, research administration, audit or other area of research, compliance or oversight.
Proficient to advanced computer skills; proactive; strong organizational skills; demonstrated knowledge of organizational and administrative support processes.
Demonstrated proficiency taking and transcribing notes and minutes and/or formal proceedings.
Excellent verbal and written communication and interpersonal skills.
Clinical licensure (such as RN)
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