Clinical Research Regulatory Project Manager

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Located conveniently in the heart of Phoenix Arizona St. Josephs 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. Josephs was the first hospital in the Phoenix area. More than 125 years later St. Josephs 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. Josephs includes the internationally renowned Barrow Neurological Institute Norton Thoracic Institute Cancer Center at St. Josephs Ivy Brain Tumor Center and St. Josephs 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. Josephs is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day approximately 20 percent of the hospitals patients have traveled from outside of Arizona and the United States to seek treatment at St. Josephs.

U.S News & World Report routinely ranks St. Josephs among the top hospitals in the United States for neurology and addition St. Josephs boasts the Creighton University School of Medicine at St. Josephs and a strategic alliance with Phoenix Childrens Hospital.

St. Josephs is consistently named an outstanding place to work and one of Arizonas healthiest employers. Come grow your career with one of Arizonas Most Admired Companies.

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The Clinical Research Regulatory Project Manager position exists to support research divisions engaged in Contract Research Organization (CRO) activities as well as the conduct of clinical trials at a site level. A unique skill-set with high attention to detail and subject matter expertise in Clinical Research Regulatory Affairs management is essential to drive effectiveness eliminate redundancies and increase both sponsor and site(s) addition to managing dual (local site and CRO) regulatory obligations this role is responsible for building and maintaining relationships across the CRO site network to ensure external sites are set up for success. Obligations include proactively addressing regulatory site needs to resolve issues contribute to development of CRO policies work instructions and/or regulatory sections within study specific Manuals of Operations (MOPs). In summary this position is accountable to ensure ongoing regulatory compliance throughout the conduct of clinical trials at both a local site level and across the CRO multi-site network. This responsibility includes drafting and submission of regulatory documents and performing quality reviews of regulatory documents to ensure document accuracy reviewed and approved by obligatory review board (IRB Scientific Review Committees FDA Privacy Boards etc.) The scope of this position begins at the time of study concept site initiation and until formal study close-out.

Responsibilities Include:

• Acts as the primary regulatory liaison between the Dignity Health CRO and external sites involved in the conduct of the clinical trials. Utilizes problem-solving skills to promote positive working relationships with the site and staff.
• Assists external sites with IRB submissions maintenance of regulatory documents and responding to study related regulatory questions from sites vendors and sponsors in a timely fashion
• Ensures new protocols are submitted to the Institutional Review Board (IRB) within established time frames by drafting and coordinating appropriate paperwork. Completes all necessary regulatory submissions in a timely manner.
• Develops and maintains Trial Master Files (TMF) as well as study specific regulatory binders for use by the site(s).
• Maintains investigator CVs and medical licenses staff CVs and licenses training certificates and lab
  licenses/certifications ensuring all documents are current.

Bachelors Other in biosciences healthcare or healthcare management upon hire

Three years of related experience.

Masters Other in biosciences healthcare or healthcare management business or public health preferred.

Five years of related experience preferred.

Experience in one or more of the following areas: biosafety animal care and use institutional ethics review research administration audit monitoring or other area of research compliance or oversight.