Clinical Research Program Manager

at  St Joseph Hospital Medical Center

POSITION SUMMARY:

Responsible for administration, oversight, management, implementation and accountability of clinical research, data collection activities and clinical operations for assigned research program. Coordinates project activities, regulatory approvals, contracting and is accountable for assigned research cost center budget.

EDUCATION AND EXPERIENCE:

• Clinical background with a minimum of 5 yrs of experience in clinical research operations and/or administration.
• BSN or other Bachelor’s prepared healthcare related licensure or an equivalent combination of education and/or job related experience.
• Critical thinking, attention to detail. Excellent verbal and written communication, negotiation, listening, public speaking, problem solving ability, and organizational skills. Strong knowledge of FDA, ICH, OIG, and OCR regulations.

• Facilitates 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.
• 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.
  Qualifications