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Charlestown

    Clinical Research Coordinator - Charlestown, United States - Partners Healthcare System

    Partners Healthcare System
    Partners Healthcare System Charlestown, United States

    2 weeks ago

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    Description

    GENERAL SUMMARY/ OVERVIEW STATEMENT:


    The mission of the MGH Clinical Translational Research Unit Core (CTRU) is to support investigators in the discovery, development, and implementation of promising therapeutics and associated diagnostics for individuals with complex brain disorders affecting cognition, behavior, emotion, sensory and motor functioning, and other diseases as related to the brain.

    Under the general supervision of the CTRU Core Program Director, the Clinical Coordinator will serve as the main point of contact for research participants enrolled in 2-3 research studies conducted by investigators representing the MGH Martinos Center for Biomedical Imaging and the MGH Departments of Neurology, Psychiatry and Radiology.

    These research studies will involve intensive contact with research participants.

    Study activities may include recruitment and screening, administration of clinical rating scale assessments, complex coordination of cognitive testing measures, EEG, MRI and PET neuroimaging, and biofluid collection.

    The incumbent will be responsible for data entry and handling, monitoring the quality of data, managing regulatory documents and interactions with the institutional review board, managing communications with study sponsors, generating reports, and maintaining records related to the assigned research studies.

    Additionally, the CTRU CRC will support various investigators utilizing the CTRU.

    With supervision from each Principal Investigator and under the guidance of the CTRU Program Director, the successful applicant will be responsible for various aspects of clinical research/trial coordination for assigned clinical treatment trials.


    PRINCIPAL DUTIES AND RESPONSIBILITIES:
    Please note, the functions below are representative of major duties that are typically associated with these positions. Specific responsibilities may vary based upon departmental needs. Similarly, not all duties that have been outlined will be assigned to each position.


    • Collects & organizes patient data
    • Maintains records and databases
    • Uses software programs to generate graphs and reports
    • Assists with recruiting patients for clinical trials
    • Obtains patient study data from medical records, physicians, etc.
    • Conducts library searches
    • Verifies accuracy of study forms
    • Updates study forms per protocol
    • Documents patient visits and procedures
    • Assists with regulatory binders and QA/QC procedures
    • Assists with interviewing study subjects
    • Administers and scores questionnaires
    • Provides basic explanation of study and in some cases obtains informed consent from subjects
    • Performs study procedures, which may include phlebotomy.
    • Assists with study regulatory submissions
    • Writes consent forms
    • Verifies subject inclusion/exclusion criteria
    • Performs administrative support duties as required
    A Clinical Research Coordinator II performs the duties of a Clinical Research Coordinator I (above) and may also:


    • Maintain research data, patient fields, regulatory binders and study databases
    • Perform data analysis and QA/QC data checks
    • Organize and interpret data
    • Develop and implement recruitment strategies
    • Act as a study resource for patient and family
    • Monitor and evaluation lab and procedure data
    • Evaluate study questionnaires
    • Contribute to protocol recommendations
    • Assist with preparation of annual review
    • May assist PI to prepare complete study reports

    EDUCATION:
    Bachelor's Degree.


    EXPERIENCE:


    New graduates with some relevant course/project work or those without any prior research experience will be considered for the Clinical Research Coordinator I position outlined above.


    Those with a minimum of 1-2 years of directly related work experience may be considered for a Clinical Research Coordinator II position.


    SKILLS & COMPETENCIES REQUIRED:

    • Bilingual in English/Spanish is preferred.
    • Must be organized, detail-oriented, and have a strong motivation to learn.
    • Should be able to prioritize tasks and troubleshoot problems as necessary. Should be comfortable asking for help when needed.
    • Must be able to communicate effectively; interpersonally, verbally and written.
    • Must be comfortable interacting with colleagues and study participants both in person and over phone/video platforms.
    • Ability to work both independently and collaboratively as a member of a team.
    • Reliable and respectful of others.
    • Prior understanding of laboratory practices and procedures preferred but not required.
    • Basic computer literacy required including word processing, email and spreadsheets.
    LICENSES,


    CERTIFICATIONS:
    AHA-BLS preferred.


    SUPERVISORY RESPONSIBILITY:
    A Clinical Research Coordinator I does not have any supervisory responsibility.

    A Clinical Research Coordinator II may assist with the training and orientation of new staff members.


    WORKING CONDITIONS:


    Incumbent will have a shared workspace in Building 149 in the Charlestown Navy Yard and will be assigned a networked computer.

    The successful applicant may be expected to work from home at times and will be provided with the necessary technology/equipment to allow this.

    Visits to MGH-Main Campus may be required for delivery of biofluid samples and collection of study medication.

    Primary Location:
    USA-MA-Charlestown Work Locations: 149 13th Street Charlestown 02129

    With advance notice, be able to adapt to flexible scheduling.

    On occasion, work hours may include working shifts starting between 6 am and 8 am or ending between 6 pm and 8 pm, as well as the potential to cover overnight shifts.


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