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    Principal Clinical Science Professional - Florence, United States - University of Colorado

    University of Colorado
    University of Colorado Florence, United States

    2 weeks ago

    Default job background
    Full time
    Description
    Principal Clinical Science Professional-33420University Staff Description

    University of Colorado Anschutz Medical Campus

    School of Medicine | Department of Medicine | Division of Pulmonary Sciences and Critical Care

    Job Title: Principal Clinical Science Professional

    Position # – Requisition #33420

    Job Summary:

    This is a full-time (1.0 FTE) position for a Lead Clinical Research Coordinator within the Interstitial Lung Disease (ILD) research team, at the University of Colorado School of Medicine. This position will be supervised by Dr. Joyce Lee and will work closely with study sponsors and an interdisciplinary team of collaborative investigators on both clinical trials and investigator-initiated protocols with a focus on broadening the understanding and treatment of ILDs.

    This position will primarily focus on day-to-day oversight of the research team and the studies being conducted, ensuring regulatory compliance, protocol adherence, and achievement of study goals. Primary duties will include but are not limited to supervision and training of research coordinators, management of regulatory aspects for all ongoing and new studies, in addition to performing patient-centered coordinator duties as needed (screening and recruitment, informed consent, visit coordination, sample collection, visit scheduling, data entry, etc.).

    Key Responsibilities:

  • Oversee and provide leadership to the research coordinators, including ensuring continued compliance with research protocols, managing day-to-day priorities, evaluating, and redistributing workloads on a temporary basis, and mentoring staff.
  • Management of all study-related regulatory processes, including IRB submissions, sponsor invoicing, SMV scheduling, and regulatory document preparation.
  • Work closely with sponsors and CROs to facilitate the study start-up process, including contract and budget negotiations, site-specific ICF preparations, and preparation of all required documentation (1572, FDFs, CDAs, DOA, site-specific forms, etc.).
  • Work with PI in planning and execution of new studies, including drafting protocols, ICFs, and CRFs for investigator-initiated studies.
  • Collect information to determine feasibility, recruitment, and retention strategies
  • Employ, evaluate, and assist with the implementation of innovative solutions to maximize recruitment and retention.
  • Work Location:

    Hybrid – this role is eligible for a hybrid schedule and as needed for in-person meetings; onsite location is at the Anschutz Medical Campus in Aurora, Colorado and schedule will be coordinated with supervisor.

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