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    Senior Clinical Research Associate: Ivd

    Kelly Science, Engineering, Technology & Telecom
    5-8 years
    $50/hr - $60/hr
    Remote, USA
    10 May 22, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title:

    Senior Clinical Research Associate (Sr. CRA)

    Location:

    Remote (US)

    About the Company:

    Kelly® Science & Clinical is collaborating with a biotech company in California, dedicated to advancing scientific discoveries and pioneering diagnostic solutions.

    Responsibilities:

    • Execute all activities related to clinical trials, including clinical site selection, contract negotiation, study initiation visits, interim monitoring visits, and study close out visits.
    • Perform data monitoring activities, including on-site and remote audits of study data for accuracy, integrity, and completeness.
    • Identify and address issues at sites related to GCP or protocol compliance that may impact data integrity or the timely completion of the study.
    • Prepare study documents such as training materials, case report forms, and protocol-specific informed consent forms for review by project lead.
    • Maintain a high level of familiarity with GCP and assigned protocols.

    Requirements:

    • Bachelor’s degree in a scientific discipline (Clinical Sciences, Health/Life Sciences, Biology, Biochemistry, Human Physiology, or similar).
    • 5 to 8 years of experience in monitoring In Vitro Diagnostic (IVD) products or medical devices.
    • Proficiency in all aspects of clinical trials, including clinical site selection, study visits, preparation of study contracts and budgets, and drafting study-specific documents.
    • Up-to-date knowledge of clinical trial regulatory requirements and guidelines (e.g., GCP, ICH, FDA).
    • Excellent oral and written communication skills, with the ability to build strong relationships with investigators and site staff.
    • Willingness to travel 25 – 50%, including solo international travel 4-6 times per year to destinations such as Continental US, Sub-Saharan Africa, South Asia, Southeast Asia, South America, and Central America.

    Preferred Qualifications:

    • Experience with in vitro diagnostic (IVD) products, particularly in molecular diagnostics or immunodiagnostics, focusing on oncology and/or infectious disease.
    • Familiarity with laboratory automation and biological databases.
    • CCRA certification.

    Compensation:

    • Base Salary Range: $50/hr - $60/hr
    • Compensation may vary based on skills, experience, and location.

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