Southern Illinois Healthcare

  • CLIN TRIAL RESEARCH SPECIALIST

    Posted Date 2 months ago(9/21/2018 1:11 PM)
    Requisition ID
    2018-3125
    Job Locations
    US-IL-Carbondale
    Category
    Clinical & Technical
    Position Type
    Full Time
    Shift
    8AM-4:30PM
    Weekend Requirement
    Weekends as required
  • Overview

    Responsible for protecting the rights and welfare of research subjects while performing biomedical and social-behavioral research in accordance with Good Clinical Practice, all federal regulatory bodies, and research protocols.

    Responsibilities

    • Safety
      • Manages processes effectively in regard to employee/patient safety.
    • Record Keeping
      • Maintains all required records, reports, statistics, logs, files and other documents as required.
    • Process Improvement
      • Promotes a culture of process improvement by participating in unit/department based programs that supports the system’s process improvement goals.
      • Actively participates on system-wide or hospital-based teams as needed.
    • Role Specific Responsibilities
      • Recruits and verifies eligibility of study subjects in compliance with the principles of the Belmont Report, Good Clinical Practice, and federal regulations of OHRP and FDA.
      • Reviews and obtains informed consent and documents process;
      • Schedules and conducts study visits with subjects;
      • Conducts follow-up phone calls with subjects ;
      • Scores test results;
      • Collects survey data and review medical records
      • Consults with nurses and physicians to determine subject eligibility according to protocol requirements;
      • Facilitates communication with and education of investigators, key personnel and subjects to maintain project study flow;
      • Maintains detailed study records. Performs scientific literature searches in support of research;
      • Completes research documents in compliance with current local, state, and federal regulatory guidelines, requirements, laws and research protocols.
      • Participates in outreach to promote clinical research at SIH, including but not limited to outreach to physicians, staff, patients, or community.
      • Identifies, records, reports and follows Adverse Events (AE) and Serious Adverse Events (SAE). Collaborates with investigator to address AE and SAE resolution.
      • Identifies and reports protocol deviations, including corrective action plans.
      • Maintains test article (drug or device) and research supply accountability per protocol and SOP.

    Qualifications

    • Bachelor's degree in a social or health science. Or the equivalent combination of education and experience.
    • Must complete NIH Protection of Human Research Participants and NUCATS training before interacting with any participants and must complete continuing education annually.
    • Clinical Research Professional certification within two years of hire.

     

     

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