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    Clinical Research Associate

    Gforce Life Sciences
    3-6 years
    $100K/yr
    Trenton
    10 Aug. 16, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Clinical Research Associate (CRA)

    Contract Duration: 12 months

    Location: Remote (Princeton, NJ) – Requires up to 50% travel

    Responsibilities:

    • Ensure adherence to protocol and regulatory policies during clinical trials by training investigators and study coordinators, and by following up on corrective actions.
    • Maintain the integrity of the study by identifying and resolving discrepancies, obtaining missing data, and managing complex trial components, including core lab activities.
    • Contribute to the development and writing of clinical protocols, case report forms, and other study-related documents, addressing issues through collaboration with relevant personnel.
    • Stay current on regulations for applicable geographies and study types (e.g., IDE, non-significant risk, feasibility, exempt) and act as a resource on clinical trial regulations.
    • Provide training for contract research organizations (CROs) that offer additional monitoring support.

    Qualifications:

    • Bachelor’s degree in a related field.
    • Experience in multi-site data monitoring, covering all visit types, with a strong understanding of U.S. regulations.
    • Proven ability to create and review clinical documents such as training materials for site initiation visits (SIVs), protocols, case report forms (CRFs), informed consent forms (ICFs), and brochures.
    • Participation in data management activities, including user acceptance testing (UAT) and study reviews.
    • Minimum of one year of clinical research experience on the sponsor side.
    • 3-6 years of experience in a clinical environment, preferably with medical device and/or in vitro diagnostic (IVD) experience.

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