Job Description

  • Job LocationUS-AZ-SCOTTSDALE
    Requisition ID
    2018-13265
    Shift
    01 - Days
    Department
    HHRI Clinical Trial Ops
    Facility
    Shea Medical Center
    Position Type
    Regular Full-Time
    Physical Work Location and New Employee Orientation Location : Address
    10510 N. 92nd St
    Work Hours (ex:M-F, 8am - 4pm)
    Monday-Friday
  • Overview

    HonorHealth is a non-profit, local healthcare organization known for community service and outstanding medical quality. HonorHealth encompasses five acute care hospitals with approximately 11,500 employees and 4,500 volunteers, over 70 primary and specialty care practices, clinical research, medical education, an inpatient rehabilitation hospital, an Accountable Care Organization, two foundations, and extensive community services.

    HonorHealth is a leader in medical innovation, talent and technology with a genuine commitment to your growth. The health system's vibrant careers take place in an environment filled with opportunity and respect because we see the HONOR in you.

    Qualifications

    Education
    Bachelor's Degree in health science field, or 4 years related research experience. Required

    Experience
    2 years experience in clinical research, including data coordination, document and regulatory management, regulatory compliance, and quality assurance. Required

    Responsibilities

    Job Summary
    Under the direction of the Program Manager, Regulatory Affairs, this position coordinates, assesses, plans, and facilitates Regulatory Affairs at the Research Institute in the areas of training and compliance, system-wide use of Good Clinical Practice principals, and application of FDA and ICH guidelines. Responsible for the implementation and maintenance of study protocols from planning, through startup, lifecycle and closure. Studies range from industry-sponsored and investigator-initiated investigational agent, tissue acquisition, and chart/imaging review study protocols. Knowledge of clinical research trials regulations i.e., OHRP and the FDA, Good Clinical Practice (GCP) and the International Conference on Harmonisation (ICH) is essential.
    • Prepares and submits documents related to the protection of human subjects to the relevant IRB and scientific review groups.
    • Coordinate and/or review all submissions to the IRB (which may include multiple IRB’s) and other required committees, including new protocol applications, protocol amendments, informed consent documents, progress reports, and serious adverse events (SAE) and Investigational New Drug (IND) Safety Reports. Review submission of protocols to Institutional Review Boards (internal and external). This includes exempt, minimal risk and greater than minimal risk human research protocols.
    • Understand and coordinate with the Program Manager Regulatory Affairs, compliance with regulations as they apply to multi-center clinical research studies.
    • Develop of regulatory documents, including informed consent templates, and departmental operating procedures.
    • Be knowledgeable of local, state and federal regulations that apply to human subject’s research, including Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) regulations, sponsor guidelines and all Standard Operating Procedures (SOP).
    • Interacts with the third party monitors for regulatory compliance and responds to regulatory queries.
    • Assist research staff and PIs in initiating, following-up, negotiating, and resolving issues regarding current and future submissions; participate in direct discussions with the appropriate regulatory agencies and other parties. Assist physicians and other staff in meeting human subject protection standards in research. As necessary, participate in creation of supporting documents for research involving human subjects.
    • Coordinate and/or review regulatory correspondence with FDA and other regulatory agencies as necessary; interact with FDA and other regulatory agencies on project-related issues, applicable policies and other relevant issues.
    • Execute and maintain a system for maintenance of all regulatory documents, including study-specific regulatory binders. Execute and maintain online database for tracking all study documents.
    • Review sponsor guidelines for each study to ensure compliance with Standard Operating Procedures; suggest modifications as necessary for compatibility.



    It is the policy of HonorHealth to provide equal opportunity in employment. Selection and employment of applicants will be made on the basis of their qualifications without regard to race, color, religion, creed, national origin, age, disability, sexual orientation, marital status, veteran status or any other legally protected status.

    Please review the Equal Employment Opportunity poster.

    Please review the Equal Employment Opportunity Poster.HonorHealth wants all interested and qualified candidates to apply for employment opportunities. If you are an applicant with a disability who is unable to use our online tools to search and apply for jobs, please contact us at EmploymentOffice@HonorHealth.com . Please indicate the specifics of the assistance needed. This option is reserved only for individuals with disabilities that are unable to use the online tools and is not intended for other purposes.

    Application Instructions

    Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!

    Apply Online