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    Clinical Research Program Manager - Phoenix, United States - Dignity Health

    Dignity Health
    Dignity Health Phoenix, United States

    2 weeks ago

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    Description

    Overview
    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 ) .

    Look for us on Facebook ) and follow us on Twitter ) .

    _For the health of our community ... we are proud_ _to be_ _a tobacco-free campus._


    Responsibilities
    Barrow Neurological Institute (BNI) at Dignity Health St.

    Joseph's Hospital and Medical Center is an internationally renowned medical center with one of the most experienced and expert stroke programs in the country.

    BNI is home to the Petznick Stroke Center, caring for more stroke victims than any other center in the southwestern United States.

    Our team of accomplished physicians and scientific investigators serves as a destination center of excellence for stroke care and research discovery.


    We are excited to announce a new search for a dedicated Stroke Research Program Manager to join our rapidly growing research team.

    This position exists to oversee our clinical stroke treatment and prevention research trials with focus on clinical trial conduct and leadership of the newly created Stroke Research Team.

    The successful candidate will have a combined working knowledge of clinical stroke programs, national care guidelines, stroke care delivery and research operations to successfully advance this rapidly growing program at BNI.

    This position works diligently to support the research interests of all investigators and to foster interdisciplinary partnerships to facilitate research from concept to close-out.

    Additional responsibilities include day-to-day oversight of research operations, fiscal management and promotion of a compliant research culture based on the principles of Good Clinical Practice, Good Laboratory Practice, Federal Regulations and Dignity Health policies.


    This position reports directly to the BNI Research Operations Manager, partners with physician leaders and works collaboratively with inpatient and outpatient stakeholders across the stroke program.


    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.


    Principal Duties and Accountabilities:

    • 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

    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.

    Preferred:

    • 8 yrs of clinical research-related experience.
    • Master's Degree in Healthcare related field preferred. Certification in Healthcare Research Compliance through the Health Care Compliance Association (HCAA).

    Pay Range
    $ $53.60 /hour

    We are an equal opportunity/affirmative action employer.
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