• Clinical Research Coordinator I-II

    Requisition Number 2019-1584
    Department Clinical Research
  • Overview

    Clinical Research Coordinator I

    A Clinical Research Coordinator  (CRC) I performs increasingly complex tasks to facilitate cancer clinical research.


    Clinical Research Coordinator II


    A Clinical Research Coordinator (CRC) II performs increasingly complex studies, test article (TA), disease or earlier phase studies, and assists with a variety of duties related to the conduct of oncology clinical research protocols.

     

    These are not lab based positions.

    Responsibilities

    Clinical Research Coordinator I


    Responsibilities may include new study preparation, the creation of study budgets, 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, and ensuring site quality.

    Subject care requirements may include appointment scheduling, records review, treatment coordination, collecting vital signs, subject health assessment, and telephone triage/screening. The CRC may also perform phlebotomy, specimen processing and participate in process improvement events as necessary.


    Clinical Research Coordinator II


    May include new study preparation, subject screening and recruitment, informed consent, subject history, adverse events, concomitant medication review, regulatory document filing, preparation for study monitor visits, TA handling, completion of case report forms, maintenance and development of source documents, eligibility verification, proper standard or research billing, and ensuring site quality.

    Subject care requirements may include appointment scheduling, arriving, records review, treatment coordination, collecting vital signs, subject health assessment, telephone triage/screening, at all times the CRC will ensure protocol compliance and subject safety. The CRC may also perform phlebotomy, specimen processing using universal precautions when appropriate and consistent with licensure and participate in process improvement activities, root cause analysis and create corrective and preventive action plans.

    The CRC must maintain subject and document confidentiality at all times, understand and comply with the appropriate sponsor requirements, regulations including the Food and Drug Administration (FDA), Good Clinical Practices (GCP’s) and International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards, (IRB) and institutional policies and procedures.  In some instances, may provide guidance or informal supervision of a Research Assistant or CRC I in the conduct of their study.

    Requirements

    Clinical Research Coordinator I


    Requires good medical knowledge including medical terminology, and basic subject care. May require phlebotomy skills and the ability to operate centrifuges and EKG machines. Prefer higher education or vocational training specializing in healthcare.
     
    Minimum one year of full-time related experience. May require Healthcare Assistant Certificate or other specialized training. Previous experience in cancer clinical research is a plus.


    Clinical Research Coordinator II

     

    Two years of experience in clinical research is required.  A Bachelor’s degree and SOCRA or ACRP certification is strongly preferred.  May substitute a Masters in clinical research or related field or M.D. for the two years of clinical research experience.

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