Program Manager Clinical Research

As our Program Manager of Clinical Research, you will be responsible for the administration, oversight, management, implementation and accountability of clinical research, data collection activities and clinical operations for assigned research program.

In this role, you will coordinate project activities, regulatory approvals, contracting and is accountable for assigned research cost center budget.

To be sucessful in this role you will facilitate research activities in partnership with program Medical Director(s) and Research Administration colleagues leveraging clinical experience in related specialty area. Activities include coordination of grant submissions and sponsored clinical trials. Work includes management of site selection process, site initiation visits, and study submissions consistent with regulatory requirements and local policies.

Responsibilities include:

• Directs, organizes and plans the daily research operational activities of the program and support staff to manage and grow the divisions research activities. Serves as the primary liaison for internal and external project sponsors, routinely informing key stakeholders of project plans, status updates, milestones (including subject enrollment metrics, timely data collection and submission and related contract and/or grant goals) through regular reporting and coordinated discussions.
• Manages program budget working synergistically with Research Administration to perform and coordinate transactional tasks; i.e., sponsor invoicing, patient financial billing, time and effort reporting, etc. Proactively manages supplies, staffing needs and research portfolio via forecasting reports to ensure a robust study pipeline is in place. Acts as the program fiscal steward and works to promote and grow the research portfolio thru public relations, web-based activities, newsletters and social media outlets.
• A strong working knowledge of GCP, ICH, DHHS, OIG and FDA regulations and depth of clinical expertise in the assigned area is required along with familiarity of all applicable federal and state regulations and institutional policies. Coordinates the process flow of a study from initial concept to IRB through the final study closure. Facilitates feasibility reviews based upon governing policies.

Required

• Bachelors Degree of Science in Nursing
• Minimum of five (5) years experience in related field
• Three (3) years management experience
• Licensed Registered Nurse: AZ
• Certified Clinical Research Associate (CCRA)

Preferred

• Masters Degree in healthcare related or business field
• ACRP Certified Clinical Research Coordinator or Certified Clinical Research Professional, within 12 - months

Hello Humankindness: Join a Legacy of Healing at Saint Joseph’s Hospital and Medical Center (SJHMC) 

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