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Sugar Land

    Research Assistant II - Sugar Land, United States - DM Clinical Research

    DM Clinical Research
    DM Clinical Research Sugar Land, United States

    1 week ago

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    Description

    Job Description

    Job DescriptionResearch Assistant II

    The Research Assistant will be responsible for assisting the clinical research staff in conducting clinical research trials and assisting in the pre-screening process.

    DUTIES & RESPONSIBILITIES
    • Completing DMCR-required training, including GCP and IATA.
    • Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols.
    • Assisting in the collection and recording of patient data per Sponsor requirements via the respective EDC system.
    • Timely and accurately assist in collection, management, and shipment of subjects' samples, and/or specimens
    • Completing Sponsor-required training prior to study-start, including, but not limited to:
      • Sponsor-provided and IRB-approved protocol
      • All amendments
      • Investigator Brochure
      • Sponsor-specified EDC and/or IVRS
    • This includes completing the above-mentioned training prior to any study-related procedures being conducted on that said protocol should the RA be added to a protocol post-study start.
    • Maintaining clear, concise, accurate, and legible records.
    • Being prepared for and available at all required company meetings and monitoring visits for their assigned protocols at their respective site(s).
    • Utilizing the most recent version of the Protocol, Informed Consent, and Investigator Brochures at their respective site(s).
    • Assisting in the compilation and organization of all regulatory and administrative binders for their assigned protocols at their respective site(s) upon initial receipt of and wherever applicable.
    • Assisting in the creation of source documents for their assigned protocols at their respective site(s).
    • Conducting patient visits.
    • Assisting in reporting Adverse and Serious Adverse Events to the appropriate authorities per Sponsor.
    • Assisting in addressing and resolving issues from internal/external audits and monitoring letters for all assigned protocols at their respective site(s) in a timely manner.
    • Assists with all other aspects of the study and conducts as needed.
    • Assist the lab team in conducting EKG/ECGs.
    • Assist the lab team in blood drawing and lab processing.
    • Able to manually take patient blood pressure.
    • Assists in conducting rapid clinical tests.
    • Any other matters as assigned by management.

    KNOWLEDGE & EXPERIENCE

    Education:
    • High school diploma or equivalent required
    Experience:
    • 1-2+ years experience in the clinical field
    Credentials:
    • Phlebotomist certificate preferred
    • Medical Assistant Certification preferred
    Knowledge & Skills:
    • Knowledge of medical terminology required
    • Must be detail-oriented and demonstrate attention to detail
    • Excellent customer service skills
    • Excellent computer skills
    • Patient-centric focus.
    • Strong organizational and time-management skills.
    • Able to work in a fast-paced environment ensuring limited oversights.

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