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    Clinical Research Coordinator - 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 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.


    This is an open-rank posting (there are 4 levels of Clinical Research Coordinator) - candidates will be hired into the level commensurate with their experience.


    Responsibilities:

    ESSENTIAL FUNCTIONS:

    Clinical Research Coord I:
    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, tests and/or interviews/telephone follow up calls

    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.

    Clinical Research Coord II


    Duties noted above plus:
    Conduct preliminary quality assurance reviews of study data

    Contribute to data presentations and Institutional Review Board (IRB) processes

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

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

    Document and collect data/ samples for research related procedures performed during participant study visits. Ensure clinicians and/or PI accurately document their study activities according to protocol.

    Monitor strict adherence to all study protocols, including all regulatory requirements adhering to appropriate federal, local and institutional guidelines. Identify and resolve issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding compliance

    Clinical Research Coord III


    Duties noted above plus:
    Assist with recruiting, screening, selecting, maintaining and terminating study subjects for multiple protocols

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

    Direct the activities of research support staff. Assist with the training of staff

    Develop preliminary designs for study related documentation of data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)

    Contribute to grant preparation, assessment of protocol feasibility, manuscript writing, data presentations and Institutional Review Board (IRB) processes

    Sr Clinical Research Coord


    Duties noted above plus:
    Responsible for internal review/monitoring of clinical data for quality assurance purposes. Reports findings


    Responsible for the smooth operation of all assigned studies on a day-to-day basis, interacting with investigators, staff members, clinicians, sponsors, etc.

    to ensure project timelines and goals are met

    Contribute independently to the development of preliminary designs for study related documentation of data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)

    May Supervise the activities of research support staff. Assist with the selection, training, and supervision of staff

    Prepare ongoing summary reports from various data sources, and collaborate with investigators on data presentation, interpretation, and the writing of manuscripts for publication and grant proposals

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

    Accountable for quality assurance reviews of study data

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

    Contribute independently to grant preparation, assessment of protocol feasibility, manuscript writing, data presentations and Institutional Review Board (IRB) processes


    Qualifications:

    REQUIRED QUALIFICATIONS:

    Clinical Research Coord I:
    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


    Clinical Research Coord II:

    Requirements noted for CRC I plus:
    1-3 years of related experience


    Clinical Research Coord III:

    Requirements noted for CRC I plus:
    3-5 years of related experience


    Sr Clinical Research Coord:

    Requirements noted for CRC I plus:
    5-7 years of related experience

    Demonstrated knowledge of quality management principles in a scientific or hospital setting
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