Dignity Health Clinical Research Regulatory Specialist in PHOENIX, Arizona
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.
The Clinical Research Regulatory Specialist is responsible and accountable for ensuring inpatient and outpatient research protocols are coordinated through the regulatory process at study start-up and through the life of the study. .
Institutional Review Board (IRB) applications and modifications, tracking of IRB approvals, completion of continuing review reporting, and preparation and assistance with internal and sponsor monitoring visits.
Demonstrated knowledge and understanding of human research policies, regulations, procedures and standards according to FDA, ICH, GCP guidelines is required.
This position interacts with a variety of customers, both internal and external, requiring exceptional communication skills.
The ability to multi-task and remain organized in a high volume clinical trial setting is required
Education and Experience:
3-5 years related experience
Associate degree or equivalent combination of education and experience
Previous training in the area of regulatory submissions, research administration or other clinical trial experience
Proficient to advanced computer skills; proactive strong organizational skills. Excellent verbal and written interpersonal skills
Preferred: Professional certification in research; CCRP, CCRC, CIP, or RAC.
Bachelor's Degree and Five + years of experience preferred
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If you need a reasonable accommodation for any part of the employment process, please contact us by telephone at (415) 438-5575 and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this telephone number.
Job ID 2018-60535
Employment Type Full Time
Department Dignity Health Research Institute Administration
Hours / Pay Period 80
Facility St Josephs Hospital and Medical Center
Standard Hours 0800-1700 M-F
Work Schedule 8 Hour