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    Project Support Coord

    Thermo Fisher Scientific
    2+ years
    Not Disclosed
    Bangalore
    10 Nov. 11, 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

    Job Title: Clinical Trial Coordinator

    Location: [Insert Location]
    Job Type: Full-Time

    Job Description:

    As a Clinical Trial Coordinator, you will be responsible for overseeing, coordinating, and completing various tasks within assigned clinical trials. This includes managing key study documentation, monitoring study progress, ensuring compliance, and maintaining high-quality standards. You will work closely with internal teams, vendors, and clients to ensure tasks are completed on time and within budget.

    Your key responsibilities include:

    • Task Coordination: Oversee and manage functions based on the task matrix, ensuring tasks are completed on schedule and meet quality standards.
    • File Reviews & Documentation: Perform internal, country, and investigator file reviews, document findings, and follow up on resolutions. Raise issues as necessary.
    • Study Oversight: Manage study-specific documentation, including tracking project-level plans, system access, and training requirements. Ensure that project milestones are being met according to plan.
    • System Support: Provide support for systems like CTMS, Oracle Activate, and eTMF, ensuring proper management of study documents, audit readiness, and compliance. Track access requests, and help manage non-compliance issues.
    • Administrative Support: Process documents for CRG's/Client eTMF; coordinate mass mailings; provide reports and documents to internal teams.
    • Meeting Coordination: Schedule and organize client or internal meetings, prepare meeting minutes, and follow up on action items.
    • Study Metrics & Vendor Tracking: Export and reconcile study metrics, identify issues, and maintain vendor trackers for accuracy.
    • Investigator Site File (ISF): Support the compilation and coordination of the ISF and pharmacy binder under the direction of the Clinical Team Manager.
    • Study Set-Up: Attend Kick-Off and Project Launch meetings, take notes, and assist with the initial study set-up.

    Education and Experience:

    • Education: High School diploma (or equivalent) with relevant formal academic or vocational qualifications.
    • Experience: At least 4 years of previous experience in clinical trials or a related field that provides the knowledge and skills required to perform the job.
    • Technical Qualifications: Specific certificates may be required for certain positions.

    Skills and Competencies:

    • Strong organizational skills and the ability to handle multiple tasks simultaneously.
    • Ability to manage project documentation and ensure compliance with regulatory requirements.
    • Proficiency in managing and using clinical trial management systems (CTMS, Oracle Activate, eTMF).
    • Strong communication skills, both written and verbal, with the ability to interact with internal teams, vendors, and clients.
    • Detail-oriented with a focus on ensuring high standards of quality and efficiency.

    Reasonable Accommodations:

    [Insert Company] is committed to providing reasonable accommodations for individuals with disabilities. If you need assistance during the application or interview process, please reach out to us directly to request accommodations.

    Recruitment Fraud Notice:

    [Insert Company] has discovered instances of fraudulent employment activities by parties pretending to represent the company. We encourage you to be cautious when providing personal or financial information during the recruitment process. For further information on how to protect yourself, please review our Recruitment Fraud Notice.

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