• Clinical Research Coordinator I-II

    Requisition Number 2019-1593
    Department Diabetes Clinical Research Program
  • Overview

    A Clinical Research Coordinator (CRC) performs a complex set of tasks to facilitate clinical research which may include working with affiliate or collaborating research sites, as well as conducting BRI-based research studies.

    Responsibilities

    Clinical Research Coordinator I

    • New study preparation
    • Subject screening and recruitment
    • Informed consent
    • Subject history
    • Adverse events
    • Concomitant medication review
    • Regulatory document filing
    • Preparation for study monitor visits
    • Test article (TA) handling
    • Completion of case report forms
    • Maintenance of source documents
    • Proper standard or research billing
    • Ensuring site quality

     

    Subject care requirements may include:
    o Appointment scheduling, arriving
    o Records review, treatment coordination
    o Collecting vital signs
    o Subject health assessment
    o Telephone triage/screening
    o Ensure protocol compliance and subject safety at all times

    • Perform phlebotomy
    • Specimen processing using universal precautions when appropriate and consistent with licensure
    • Participate in process improvement events as necessary



    Clinical Research Coordinator II
    • Perform the same duties as a CRC I, except:
    o Deals with increasingly complex studies, TA, disease, or earlier phase studies requiring increased depth of knowledge with all regulations, policies and procedures
    o Provide guidance or informal supervision of a Research Assistant or CRC I in the conduct of their study

    Requirements

    • Must maintain subject and document confidentiality at all times
    • Understand and comply with the appropriate sponsor requirements, regulations including:
    o Food and Drug Administration (FDA)
    o Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)
    o Health Insurance Portability and Accountability Act (HIPAA)
    o Institutional Review Boards, (IRB) and institutional policies and procedures
    • Knowledge of medical terminology and basic subject care
    • Ability to operate centrifuges and EKG machines is preferable
    • Higher education or vocational training specializing in healthcare

    Clinical Research Coordinator I

    • Minimum one year of full-time related experience as Medical Assistant/Phlebotomist
    • Registered licenses; licensure may be completed after hire

     

    Clinical Research Coordinator II

    • Minimum two years of full-time related experience as Medical Assistant/Phlebotomist
    • Registered licenses; licensure may be completed after hire
    • SOCRA or ACRP certification

     

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.

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