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    Clinical Research Coordinator I - Worcester, Massachusetts, United States - University of Massachusetts Medical School

    University of Massachusetts Medical School
    University of Massachusetts Medical School Worcester, Massachusetts, United States

    2 days ago

    Default job background
    Permanent
    Description

    Overview:

    POSITION SUMMARY:


    Under the direction of the Principal Investigator (PI) or designee, the Clinical Research Coordinator I is responsible for independently performing delegated tasks and procedures involving human subject research.

    This work includes coordination of regulatory activities and aspects of collection and management of data for research protocols related to treatment, ancillary services, and prevention practices.


    Responsibilities:

    ESSENTIAL FUNCTIONS:
    Obtain consent of research participants in accordance with the IRB approved protocols and all applicable regulations including HIPAA

    Identify, schedule and/or conduct participant study visits, interviews, and tests

    Coordinate participant remuneration/compensation per protocol

    Maintain all regulatory documentation, including local or central IRB and study data. Provide data/support to study Investigators, sponsors and/or external monitors/auditors

    Identify issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding compliance

    Document and collect data and/or samples for research related procedures performed during participant study visits.

    Ensure clinicians and/or PI accurately document their study activities according to protocol

    Track and maintain study enrollment and completion of milestones

    Assist with financial /operational aspects of grant and contracts. May be responsible for clinical research billing review within the required timeframe.

    Track and maintain study related information in the data management system within the required timeframe

    Responsible for monitoring the inventory of research related supplies

    Participate in grant preparation, manuscript writing, data presentations and Institutional Review Board (IRB) processes

    Provide detailed written summaries from literature searches and related sources to serve as a resource for the study team and clinicians/PIs

    Present study status reports related to assigned research projects

    Participate in the design, development, and documentation of study related data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)

    Maintain strict adherence to all study protocols, including all regulatory requirements adhering to appropriate federal, local and institutional guidelines.

    Comply with all safety and infection control standards appropriate to this position

    Adhere with established policies, health and safety regulations and requirements, procedures, and department objectives

    Adhere to Good Clinical Practice (GCP) guidelines and all human subject protection practices

    Must practice discretion and adhere to school and hospital confidentiality at all times

    Perform other duties as required.


    Qualifications:

    REQUIRED QUALIFICATIONS:
    Bachelor's degree in a scientific or health related field, or equivalent experience

    0-1 year of related experience

    Ability to travel off site locations
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