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    Clinical Research Associate Iv

    Techdigital Corporation
    1-4 years
    Not Disclosed
    Remote
    10 Sept. 18, 2024
    Job Description
    Job Type: Full Time Remote 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

    Position: Clinical Research Associate (CRA)
    Company: Beckman Coulter Diagnostics
    Location: Fully Remote

    Overview:
    The Clinical Research Associate (CRA) for Beckman Coulter Diagnostics is responsible for supporting clinical activities that generate evidence for product registration and market clearance. This position is part of the Clinical Affairs Department within the Clinical Decision Support business unit and reports to the Director of Clinical Affairs. You will join a cohesive, high-performing team that fosters a winning attitude and supports each other.

    This role offers an opportunity to leverage your clinical research expertise while integrating Danaher standard work processes to drive continuous improvement and professional development. We seek a process-oriented individual with strong communication, interpersonal, and project coordination skills.

    Key Responsibilities:

    • Assist in developing study essential document templates (e.g., study guides, worksheets) and ensure that the Trial Master File (TMF), Sponsor Site Files (SSF), and Investigator Site Files (ISF) are current and audit-ready.
    • Support clinical activities to ensure compliance with the study Monitoring Plan, protocol, regulatory standards, and IRB policies.
    • Conduct onsite and/or remote monitoring of data and oversee corrective actions.
    • Manage schedules and deliverables to meet overall study timelines.
    • Optimize centralized processes for instrument device data, reconcile instrument data with sample lists, and identify protocol deviations and data discrepancies to ensure compliance with study protocols, regulations, Good Clinical Practices (GCP), and Standard Operating Procedures.
    • Collaborate with the data management team to operate effectively within the data management plan and procedures, including the Laboratory Information Data Management System (LIDMS).
    • Support the clinical team with budget management, site compensation, accruals, contract execution, essential documentation collection, and vendor support activities.
    • Ensure adherence to PHI protection and GCP standards.

    Essential Qualifications:

    • Bachelor’s degree in life sciences or equivalent, with 4+ years of experience in in vitro diagnostics (IVD), medical device, or pharmaceutical research. Alternatively, 2+ years of experience with a Master’s degree, or 1+ year with a Doctoral degree.
    • Strong attention to detail and agility with processes; ability to apply critical thinking, analyze data using analytical tools, and solve complex problems.
    • Ability to work independently and thrive in a fast-paced, dynamic environment.
    • Proficiency in Microsoft Office, particularly Excel and Outlook.
    • Willingness to travel up to 10% as needed.

    Preferred Qualifications:

    • Experience with real-world data and cardiovascular clinical trials.
    • Familiarity with electronic data capture (EDC) systems (e.g., Medidata) and eTMF systems (e.g., Florence).
    • Clinical research certification (e.g., SOCRA, CCRA, CCRC).

    If you possess the qualifications and are excited about contributing to our mission, we encourage you to apply!

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