Clinical Research Regulatory Project Manger

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.

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) performance. In 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.

Experience

Three years of related experience required.
Five years of related experience preferred

Education
Bachelor’s degree in biosciences, healthcare or healthcare management and/or equivalent combination of education and experience.
Master's degree preferred.

Licensure Preferred:

Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), Certified IRB Professional (CIP), Certified IRB Manager (CIM) or Certified Clinical Research Associate (CCRA)

Special Skills

Proficient to advanced MS office skills; strong organizational skills; demonstrated knowledge of organizational and administrative support processes. Excellent verbal and written communication and interpersonal skills. High level of initiative and self-direction.

Training
Experience in the area of biosafety, animal care and use, institutional ethics review, research administration, audit or other area of research, compliance or oversight.