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    Clinical Trial Coordinator I

    Thermo Fisher Scientific
    0-1 years
    Not Disclosed
    Remote
    10 Sept. 27, 2024
    Job Description
    Job Type: 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

    Work Schedule

    Environmental Conditions

    Job Description

    At Thermo Fisher Scientific, you’ll find meaningful work that makes a positive impact on a global scale. Join our team in realizing our mission: enabling our customers to make the world healthier, cleaner, and safer. We equip our teams with the resources they need to achieve their career goals while advancing science through research, development, and the delivery of life-changing therapies. With clinical trials conducted in over 100 countries and ongoing innovations in clinical research through our PPD clinical research portfolio, our work spans laboratory, digital, and decentralized clinical trial services. Your commitment to quality and accuracy will help 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 to ensure audit readiness by reviewing files according to the organization’s standard operating procedures (SOPs) and departmental guidelines. You will assist in developing the critical path for site activation within assigned projects to facilitate rapid site activations. Utilizing local knowledge, organizational systems, external site lists, and sponsor directives, you will help develop and review site lists that align with the strategic needs of feasibility activities and contribute to the site tiering process.

    A Day in the Life

    • Conduct department, internal, country, and investigator file reviews as assigned, documenting findings in the appropriate systems.
    • Ensure all allocated 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 maintain current databases.
    • Handle administrative tasks for assigned trials, including timely processing of documents sent to Client (e)TMF, performing (e)TMF reviews, distributing communications, and providing documents and reports to internal team members.
    • Support the scheduling of client and internal meetings as needed.
    • Review and track local regulatory documents.
    • Maintain vendor trackers and support the start-up team in regulatory submissions.
    • Collaborate with sites to obtain documents related to site selection.
    • Work closely with teammates and clinical personnel to address site issues and risks, striving to achieve project goals.

    Keys to Success

    Education:

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

    Experience:

    • Previous experience that equips you with the knowledge, skills, and abilities necessary for the role (comparable to 6 months to 1 year).

    Knowledge, Skills, Abilities:

    • Ability to work effectively in a team or independently as required.
    • Flexibility to reprioritize workload based on changing project timelines.
    • Strong understanding of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs.
    • Proficient in English with good grammar skills, and proficient in local languages as needed.
    • Good digital literacy, skilled in MS Office (Word, Excel, PowerPoint), and capable of mastering all clinical trial database systems.
    • Effective oral and written communication skills.
    • Sound 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, forward-thinking organization and excellent career development prospects. Join us for an exciting company culture that values integrity, intensity, involvement, and innovation!

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