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    Clinical Research Coordinator I - Boston, United States - DM Clinical Research

    DM Clinical Research
    DM Clinical Research Boston, United States

    4 days ago

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    Description

    Job Description

    Job DescriptionClinical Research Coordinator I

    The CRC I will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC I will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis.

    DUTIES & RESPONSIBILITIES

    • Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.
    • Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to:
      1. Sponsor-provided and IRB-approved Protocol Training
      2. All relevant Protocol Amendments Training
      3. Any study-specific Manuals Training, as applicable
      4. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
    • Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.
    • Adherence to ALCOA-C Standards with all the relevant clinical trial documentation.
    • Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.
    • Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
    • Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols.
    • Liaising with Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols.
    • Submitting required administrative paperwork per company timelines.
    • Participating in subject recruitment and retention efforts.
    • Engaging with Research Participants and understanding their concerns.
    • Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
    • Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent
    • Facilitate effective communication between patients, healthcare providers, and research staff
    • Any other matters, as assigned by management.

    KNOWLEDGE & EXPERIENCE

    Education:

    • High School Diploma or equivalent required
    • Bachelor's degree a plus
    • Foreign Medical Graduates preferred

    Experience:

    • 1+ years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting.
    • 2+ years of experience as a research assistant, data coordinator, laboratory personnel, or equivalent experience in a clinical research setting

    Credentials:

    • ACRP or equivalent certification is preferred
    • Registered Medical Assistant certification or equivalent is preferred

    Knowledge and Skills:

    • Be an energetic, go-getter who is detail-oriented and can multi-task.
    • Be goals-driven while continuously maintaining quality.
    • Proficient communication and comprehension skills both verbal and written in the English language are required.
    • Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.

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