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    Clinical Trial Coordinator I

    Thermo Fisher Scientific
    0-1 years
    Not Disclosed
    Remote
    10 Sept. 23, 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

    Job Description

    Work Schedule: Standard
    Environmental Conditions: Office

    At Thermo Fisher Scientific, you'll find meaningful work that has a positive global impact. Join us in our mission to help our customers create a healthier, cleaner, and safer world. We provide our teams with the resources they need to achieve their career goals while advancing science through the research, development, and delivery of life-changing therapies. With clinical trials conducted in over 100 countries and ongoing innovation in clinical research frameworks through our PPD portfolio, our work encompasses laboratory, digital, and decentralized clinical trial services. Your commitment to quality and accuracy will enhance health outcomes for individuals and communities, both now and in the future.

    Discover Impactful Work

    As a member of our team, you will provide essential administrative and technical support to ensure audit readiness. You will review files according to the organization’s SOPs and departmental guidelines and assist in developing the critical path for site activation in assigned projects. Utilizing local knowledge, organizational systems, external site lists, and sponsor directives, you will help create and review site lists that align with the strategic needs of feasibility activities.

    A Day in the Life

    • Perform internal, country, and investigator file reviews as assigned, documenting findings in the appropriate systems.
    • Ensure timely, budget-compliant, and high-quality completion of allocated tasks, proactively communicating any project risks to leads.
    • Provide system support (e.g., Activate & eTMF) and maintain up-to-date databases.
    • Carry out administrative tasks for assigned trials, including processing documents for the Client (e)TMF, conducting (e)TMF reviews, and distributing communications as needed.
    • Assist in scheduling client and internal meetings as required.
    • Review and track local regulatory documents.
    • Maintain vendor trackers and support the start-up team with regulatory submissions.
    • Collaborate with sites to obtain necessary documents for site selection.
    • Work closely with teammates to meet project goals and address site issues and risks.

    Keys to Success

    Education:

    • Relevant formal academic or vocational qualification; a Bachelor’s degree is preferred.

    Experience:

    • Previous experience (approximately 6 months to 1 year) that provides the necessary knowledge, skills, and abilities for the role.

    Knowledge, Skills, and Abilities:

    • Ability to work both independently and as part of a team.
    • Flexibility to adjust priorities based on changing project timelines.
    • Strong understanding of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs.
    • Proficient in English and, if required, the local language; excellent grammar skills.
    • Good digital literacy, with proficiency in MS Office (Word, Excel, PowerPoint) and the ability to master clinical trial database systems.
    • Effective oral and written communication skills.
    • Strong judgment and decision-making abilities.
    • Capability to accurately follow project work instructions.

    Benefits

    We offer competitive remuneration, an annual incentive plan, healthcare benefits, and a range of employee perks. Thermo Fisher Scientific provides an innovative, forward-thinking work environment with outstanding career and development opportunities. Our exciting company culture values integrity, intensity, involvement, and innovation!

    Join us and be part of a team that makes a difference!

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