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    Clinical Trial Coordinator I

    Thermo Fisher Scientific
    1+ years
    Not Disclosed
    Remote
    10 Oct. 15, 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 Description

    At Thermo Fisher Scientific, you'll find meaningful work that makes a positive global impact. Join us in our mission to enable our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources they need to achieve their individual career goals while advancing science through the research, development, and delivery of life-changing therapies. With clinical trials conducted in over 100 countries, our work spans laboratory, digital, and decentralized clinical trial services. Your commitment to quality and accuracy will improve health outcomes that communities depend on—now and in the future.

    Discover Impactful Work: In this role, you will provide administrative and technical support, ensuring audit readiness by reviewing files per the organization's SOPs and department guidance. You will help develop the critical path for site activation within assigned projects, facilitating rapid site activations. By utilizing local knowledge, organizational systems, external site lists, and sponsor directives, you will assist in creating suitable site lists for feasibility activities and contribute local insights into the site tiering process.

    A Day in the Life:

    • Perform department, internal, country, and investigator file reviews as assigned, documenting findings in appropriate systems.
    • Ensure tasks are completed on time, within budget, and to high-quality standards, proactively communicating any risks to project leads.
    • Provide system support (e.g., Activate & eTMF) and ensure databases are current.
    • Handle administrative tasks for assigned trials, including timely processing of documents for the Client (e)TMF, conducting (e)TMF reviews, and managing communications.
    • Assist in scheduling client and internal meetings.
    • Review and track local regulatory documents.
    • Maintain vendor trackers.
    • Support the startup team with regulatory submissions.
    • Collaborate directly with sites to obtain necessary documents related to site selection.
    • Work with teammates to achieve targeted goals for assigned projects, connecting with clinical personnel regarding site issues and risks.

    Keys to Success:

    Education:

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

    Experience:

    • Previous experience that provides the knowledge, skills, and abilities to perform the job (6 months to 1 year).

    Knowledge, Skills, and Abilities:

    • Ability to work collaboratively in a team or independently as required.
    • Flexibility to reprioritize workload to meet changing project timelines.
    • Solid understanding of applicable country regulations, ICH Good Clinical Practices, and organizational/client SOPs and WPDs.
    • Proficient in English and local languages as needed, with strong grammar skills.
    • Good digital literacy, particularly in MS Office (Word, Excel, PowerPoint), with the ability to master clinical trial database systems.
    • Effective oral and written communication skills.
    • Strong judgment and decision-making abilities.
    • Capable of accurately following project work instructions.

    Benefits: We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific provides employment with an innovative organization and outstanding career development opportunities. Our company culture emphasizes integrity, intensity, involvement, and innovation!

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