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    Centralised Study Asso Ii

    Fortrea
    2+ years
    Not Disclosed
    Bangalore
    10 Oct. 24, 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

    About Fortrea
    As a leading global contract research organization (CRO), Fortrea is committed to scientific rigor and has decades of clinical development experience. We offer a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With operations in over 90 countries, Fortrea is transforming drug and device development for partners and patients worldwide.

    Position Overview
    Title: Clinical Study Support Specialist
    Location: Remote - USA

    In this role, you will provide essential support to clinical study teams by managing various clinical systems, maintaining study databases, and ensuring compliance with departmental procedures. Your focus will be on quality, productivity, and effective communication.

    Key Responsibilities

    • Clinical Systems Management:

      • Manage access to clinical systems and ensure compliance with CTMS.
      • Support study teams in electronic Trial Master File (e-TMF) management and data review activities.

    • Database Maintenance:

      • Maintain study databases (CTMS, IWRS, EDC) and assist in the setup of new awarded studies.

    • Reporting:

      • Generate and assist in creating study-specific reports and manage project communications.

    • Documentation Management:

      • Manage project and technical documentation, including document template creation, review, and tracking to e-TMF filing.

    • Quality Assurance:

      • Perform checks to ensure the quality of work completed and manage project metrics as determined by management.

    • Training and Compliance:

      • Complete required training on time and adhere to departmental Standard Operating Procedures (SOPs) and Work Instructions.

    • Administrative Support:

      • Provide technical and administrative support to internal departments as needed and assist in implementing revised processes and procedures.

    • Study Startup Support:

      • Assist study startup teams with tasks required for site initiation and manage uploads according to set objectives.

    • Communication:

      • Track and report on outstanding queries, ensuring timely escalation and resolution of issues.

    Additional Responsibilities

    • Assist with other study support activities as needed and contribute to team collaboration.
    • Support the review and management of study clinical trial contracts according to defined processes and timelines.

    Why Join Fortrea?
    Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

    Equal Opportunity Employer
    Fortrea is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without regard to protected characteristics. We encourage all qualified individuals to apply.

    For more information about how we collect and store your personal data, please see our Privacy Statement.

    Visit Fortrea's website for more details.

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