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Clinical Research Program Manager - RN

Company: Dignity Health
Location: Gilbert
Posted on: May 16, 2019

Job Description:

Overview Located in the Phoenix, Ariz., suburb of Gilbert, the Mercy Gilbert Medical Center, is a 198-bed, not-for profit hospital with more than 1,300 employees and almost 900 doctors on staff representing all major specialties. In 2014, Phoenix Children's Hospital launched a 22-bed pediatric unit inside the hospital. Mercy Gilbert opened in 2006 and has been a vital part of the growing community. Today it is the fifth largest employer in Gilbert. During the fiscal year ending June 30, 2016, Mercy Gilbert provided more than $24 million in community benefit. As a result of Dignity Health's mission to deliver health care and partner with the community, more than 42,000 people in the East Valley were reached through community health services. For more information visit: https://www.dignityhealth.org/arizona/locations/mercygilbert. Responsibilities Job Summary Responsible for administration, oversight, management, implementation and accountability of clinical research, data collection activities and clinical operations for the Cardiovascular Research and Investigational Devices Program at both Mercy Gilbert and Chandler Regional Hospital. Coordinates project activities, regulatory approvals, contracting and is accountable for assigned research cost center budget. 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 Minimum Qualification Minimum of five (5) years experience in related field. Three (3) years management experience. Knowledge of research regulations and principles of the ethical conduct of research. Excellent written and verbal skills. Excellent communication and negotiation skills. Experience with software applications (Word, Excel). Must possess critical thinking skills and excellent organizational skills. Knowledge of budget process. Current Arizona RN license. Membership in professional organization (ACRP or SOCRA). Active Arizona RN License and Research Society certification, or ability to obtain within 12 months of employment. Bachelor's degree in Nursing and/or Master's degree in healthcare related or business field. Current CITI training certificate #helloresearch #ACRP #SOCRASDL2017

Keywords: Dignity Health, Gilbert , Clinical Research Program Manager - RN, Executive , Gilbert, Arizona

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