Job Description

**Job Summary and Responsibilities** **Job Summary:** Manages and coordinates all facets of assigned clinical protocols from IRB preparation through query and data seal; ensuring protocol and regulatory compliance. **Essential Functions:** + Demonstrates current knowledge of federal and state regulations, guidelines, and policies governing the conduct of clinical trials. + Ensures study documents are maintained in compliance with applicable regulations, guidelines and policies (ie- FDA, OHRP, IRB) + Complies with licensure, contractual, protocol and policy requirements + Directs intradepartmental and external resource activities relating to assigned studies + Assists in the review and development of proposed study budgets + Ensures compliance with all study billing process requirements + Collaborates with the Principal Investigator to identify adverse events/ serious adverse events to ensure study subject safety and accurate and timely reporting + Completes and submits reports and regulatory documents to study sponsor, Institutional Review Board, or appropriate agency within established time frames + Provides study specific and individualized education to patients, families, colleagues and community using various teaching strategies. + Insures all departments participating in a study are in-serviced and maintains documentation of training + Acts as a liaison between patient, investigator, sponsor and cooperative centers **Job Requirements** **Minimum:** **Education and Experience:** + Bachelor's degree or equivalent combination of education and experience + Master's degree preferred + One year of clinical RN experience + One year of RN experience within clinical research preferred **Where You'll Work** Hello humankindness ( Located conveniently in the heart of Phoenix, Arizona, ( St. Joseph's Hospital and Medical Center is a 571-bed, not-for-profit hospital that provides a wide range of health, social and support services. Founded in 1895 by the Sisters of Mercy, St. Joseph's was the first hospital in the Phoenix area. More than 125 years later, St. Joseph's remains dedicated to its mission of caring for the poor and underserved. We are extremely proud to be a nationally recognized center for quality quaternary care, medical education and research. St. Joseph's includes the internationally renowned Barrow Neurological Institute ( , Norton Thoracic Institute ( , Cancer Center at St. Joseph's ( , Ivy Brain Tumor Center ( , and St. Joseph's Level I Trauma Center ( (which is verified by the American College of Surgeons). The hospital is also a respected center for high-risk obstetrics, neuro-rehabilitation, orthopedics, and other medical services. St. Joseph's is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day, approximately 20 percent of the hospital's patients have traveled from outside of Arizona and the United States to seek treatment at St. Joseph's. _U.S News & World Report_ routinely ranks St. Joseph's among the top hospitals in the United States for neurology and neurosurgery. In addition, St. Joseph's boasts the Creighton University School of Medicine at St. Joseph's, and a strategic alliance with Phoenix Children's Hospital. St. Joseph's is consistently named an outstanding place to work and one of Arizona's healthiest employers. Come grow your career with one of Arizona's Most Admired Companies ( . Look for us on Facebook ( and follow us on Twitter ( . _For the health of our community ... we are proud_ _to be_ _a tobacco-free campus._ **Pay Range** $32.38 - $48.17 /hour We are an equal opportunity/affirmative action employer.

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