Clinical Research Regulatory Project Manager

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.

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For the health of our community ... we are proud to be a tobacco-free campus.

Manages the daily operation and supervision of the Clinical Research Regulatory Affairs area and program specialist(s) in accordance with all applicable institutional, state, federal laws and regulations. Supervision includes coordination of activities with physician-investigators in providing guidance and interpretation of local policies; emphasis is needed relative to Catholic governance obligations of Dignity Health to comply with ethical standards in the operations of clinical research. Requires subject matter expertise and demonstrated working knowledge of ICH, HHS, and FDA regulations pertaining to the ethical conduct of research. Responsibilities include daily operational guidance to all SJHMC/BNI investigators requiring independent judgment and strong critical thinking skills relative to human subject research regulations to ensure the safe and ethical conduct of research. Under the direction of the Research Integrity and Compliance Officer, may serve as primary contact in support of site initiation and monitoring visits performed by pharmaceutical and device manufacturing clinical trial sponsors.

Responsibilities Include:

• Manages all functions of the Clinical Research Regulatory Affairs team with minimal input and supervision from the Research Integrity and Compliance Officer (RICO). Supports the clinical research teams in his/her assigned area(s). Responsible for coordinating all aspects of the Regulatory Affairs functions and activities, including scheduling and logistics for meetings, sponsor/monitor visits and training sessions.
• Conducts the preliminary preparation of IRB submissions to ensure completeness, compliance with administrative requirements, accuracy and scientific validity consistent with regulatory requirements and local policies.
• Independently develops study related documents including but not limited to consents, HIPAA authorizations, recruitment materials and other outward-facing documents; provides all relevant communications to the physician-investigators and clinical research teams. Provides regulatory and technical guidance to the clinical program managers, physician-investigators and clinical research teams.
• Accomplishes Regulatory Affairs resource objectives by selecting, orienting, training, coaching, and disciplining employees. Communicates job expectations and conducts performance evaluations.
• Manages work flow and assigns projects. Creates and maintains, or supervises the maintenance and coordination of complex filing systems, records and/or data systems.
• Prepares narrative and information reports, as needed or requested; compiles and organizes information requiring the understanding and evaluation of data sources.
• Principal liaison with other institutional offices and/or external agencies. Transmits authoritative information and serves as a resource regarding policies and procedures related to research compliance functions, with responsibility to interpret such policies and procedures.
• Stays abreast of frequently changing federal regulations, guidelines and other scientific literature related to bench, animal and human subject research.
• Identifies areas of risk and potential non-compliance.
• Participates in the review of operating procedures for efficiency and effectiveness, develops or recommends changes or improvements.
• Serves as the primary contact for complex problems, questions and issues related to the Regulatory Affairs.
• Performs related duties as required.

Education and Experience:

• Minimum of five (5) years experience in related field. 
• Seven years of related experience preferred.

• Bachelor's degree or equivalent combinations of education and experience
• Master's degree preferred.

Licensure:

Preferred:

Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), Certified IRB Professional (CIP) or Certified IRB Manager (CIM)
 
Special Skills
Proficient to advanced computer skills; proactive; strong organizational skills; demonstrated knowledge of organizational and administrative support processes.

Demonstrated proficiency taking and transcribing notes and minutes and/or formal proceedings. Excellent verbal and written communication and interpersonal skills.

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