CLINICAL RESEARCH COORDINATOR I

University of Alabama at Birmingham, United States

Updated: 2 days ago
Location: Birmingham, ALABAMA

CLINICAL RESEARCH COORDINATOR I - (T216574)

Description

 

The University of Alabama at Birmingham (UAB), Department of Ped - Neonatology, is seeking a Clinical Research Coordinator I. This position will provide and support all aspects of coordination for clinical research. Tasks will include subject screening, recruitment, consenting, protocol-driven nursing skills, data collection and assessments, AE and SAE assessments; communicating with the research team and the principal investigator, and working with sponsors and monitors; mentoring and training junior staff.

General Responsibilities

  • To collect and record preliminary data for clinical research programs.
  • To recruit and perform follow-up with research participants as protocols outline.
  • To schedule visits according to research protocols.
  • To assist in coordination of lab and fieldwork.
  • To maintain familiarity with appropriate Good Clinical Practice (GCP) guidelines and regulations.

Key Duties & Responsibilities

  • Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks.
  • Assist with addressing and correcting findings from study monitoring and study audit visits.
  • Collect, prepare, or process adverse event information independently.
  • Complete and submit adverse event reports.
  • Screen participants for all studies independently.
  • Identify and explain the risks and benefits to a subject as these pertain to a clinical trial.
  • Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs.
  • Evaluate processes to identify issues related to recruitment and retention rates.
  • Conduct and document consent for participants in a variety of studies independently.
  • Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
  • Develop UAB IRB documents such as consent forms, protocols, and continuing reviews independently.
  • Communicate to research participants, both orally and written, the difference between clinical activities and research activities.
  • Assist junior staff in the ethical conduct of research, and provide guidance in strategies used to maintain safety.
  • Use required processes, policies, and systems to ensure data security and provenance.
  • Recognize and report vulnerabilities related to security of physical and electronic data. May serve as mentor to other staff.
  • Maintain training requirements and develop solutions to proactively ensure study team members' compliance with training requirements.
  • Map a protocol's data flow plan: data capture, storage, management, quality, and preparation for analysis.
  • Use Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations with little assistance.
  • Enter data accurately.
  • Score tests and measures according to protocol, and appropriate to the role.
  • Performs other duties as assigned.

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    Annual Salary Range:     $41,175 - $66,915

     

    Qualifications

     

    High School diploma or GED required.

     
    Primary Location
    : University
    Job Category
    : Clinical Research
    Organization
    : 311653200 Ped - Neonatology
    Employee Status
    : Regular
    Shift: Day/1st Shift
    Work Arrangement (final schedule to be determined by the department/hiring manager): Onsite

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