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    Associate Clinical Research Iii

    Abbott
    6+ years
    $83,600.00 – $167,200.00
    Alameda Albany
    10 Nov. 25, 2024
    Job Description
    Job Type: Full Time Education: MSc./M. Pharm/PhD 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

    Abbott - Associate Clinical Research III

    Company Overview: Abbott is a global healthcare leader committed to improving health and helping people live more fully at all stages of life. With a focus on creating breakthrough science, Abbott offers life-changing technologies across diagnostics, medical devices, nutrition, and branded generic medicines. The company serves people in over 160 countries, with 114,000 employees dedicated to improving health through innovative medical solutions.

    Position Overview:

    The Associate Clinical Research III will support the clinical execution and management of all aspects of assigned clinical studies, including planning, implementation, and reporting. This role is crucial for ensuring studies meet quality standards, timelines, and regulatory compliance. The incumbent will contribute to both internal and external clinical studies and collaborate with cross-functional teams to advance product development.

    Key Responsibilities:

    • Study Management:
      • Assist in the design, execution, and monitoring of clinical studies from concept to clinical study report.
      • Participate in the design and execution of Abbott-sponsored external clinical studies, including PMA and outcome studies.
    • Site Management:
      • Help in identifying and qualifying external clinical sites.
      • Perform site visits (SQV, SIV, IMV, COV) and ensure compliance with the Study Protocol, Good Clinical Practices (GCP), ICH guidelines, and federal regulations.
      • Maintain communication with clinical sites, providing support in study conduct and compliance.
    • Operational Support:
      • Manage study devices and supplies, ensuring shipment to clinical sites.
      • Assist in planning study conduct, designing case report forms (CRFs), and selection/training of investigators.
      • Maintain and audit Trial Master File (TMF) to ensure inspection readiness.
    • Collaboration & Reporting:
      • Participate in cross-functional team activities for product development and clinical trial execution.
      • Review clinical data for completeness and accuracy, escalating issues when necessary.
      • Effectively communicate study progress to management and contribute to interim/final reviews of study data for regulatory submissions.
      • Prepare documentation related to study conduct (e.g., TMF, clinical protocols, reports).
    • Regulatory Support:
      • Assist in preparing for audits and respond to FDA inquiries, working with Regulatory Affairs (RA) and Quality Assurance (QA) teams.

    Required Qualifications:

    • Education: BS degree in life sciences.
    • Experience:
      • Minimum of 6 years of experience in clinical research, including at least 3 years of relevant experience in site monitoring, clinical trial practices, and regulations.
      • Experience in conducting medical device and/or in-vitro diagnostics studies is highly desirable. Pharmaceutical experience may also be considered.
    • Skills:
      • Solid understanding of the clinical trial process, including study design, conduct, clinical data management systems, and reporting.
      • Strong teamwork, communication, and interpersonal skills with the ability to build rapport with peers, management, and external stakeholders.
      • Demonstrated ability to manage clinical trials and ensure deliverables are met within agreed budgets and timelines.

    What Abbott Offers:

    • Career Development: Opportunities for growth within an international company.
    • Benefits:
      • Free medical coverage for employees through the Health Investment Plan (HIP) PPO.
      • Excellent retirement savings plan with a high employer contribution.
      • Tuition reimbursement, Freedom 2 Save student debt program, and FreeU education benefit for affordable degree completion.
    • Recognition: Abbott is consistently named as one of the best places to work, including for diversity and inclusion.

    Salary Range:

    • Base pay ranges from $83,600 to $167,200, with variation based on location and experience.

    This role offers an exciting opportunity to contribute to clinical research within a global healthcare leader, supporting the development of life-changing products and improving patient care through innovative studies.

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