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. The Dignity Health Research Institute 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.
Principal Duties and Accountabilities:
Job duties will include the review and preparation of site informed consent forms, collection and maintenance of regulatory documents, completion of 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:
Associate degree or equivalent combination of education and experience
Minimum 3-5 years related 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.
Preferred: 5 + years of experience and Bachelor's degree.
Internal Number: 2018-61142
About Dignity Health Research Institute - Arizona
At Dignity Health, we believe research is the cornerstone of every cure. We believe research provides opportunity to improve quality of life, an opportunity to improve health care for the next generation, an opportunity to find a cure. And we believe that connecting people and our patients with that opportunity is a basic tenet of humankindness.
Dignity Health offers more than 1,000 active clinical trials and research protocols to patients in California, Nevada, and Arizona.
Our investigators are among the nation’s most renowned doctors in their fields and are supported by dedicated staff.
The Dignity Health Research Institute team participates in multi-center, national and international clinical research trials, including many National Institutes of Health studies. The team also works in conjunction with highly-regarded academic institutions across the country. The ongoing growth both in trial volume and trial diversity represents a significant opportunity to patients and doctors, both within our care sites and in the communities we serve.
The mission of the Dignity Health Research Institute is to support continued innovation with the goal of finding new ways to provide t...imely and effective treatment to patients.
To learn more about the Dignity Health Research Institute ARIZONA region please call 866-367-4373 or DHRIAZ@DignityHealth.org