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    Fsp Clinical Trial Coordinator I

    Thermo Fisher Scientific
    1-3 years
    Not Disclosed
    Remote
    10 Sept. 11, 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

    Work Schedule
    Standard (Mon-Fri)

    Environmental Conditions
    Office

    Job Description

    Clinical Research Coordinator (CRC/CTC) Role

    Thermo Fisher Scientific is looking for an organized and motivated Clinical Research Coordinator (CRC) or Clinical Trial Coordinator (CTC) to provide essential support to our project teams. In this role, you will contribute to the success of clinical trials by ensuring compliance with SOPs, supporting site activation activities, and maintaining key project documents. This is an exciting opportunity to play a vital role in the critical path of clinical trial execution.

    Summarized Purpose: As a Clinical Research Coordinator, you will provide both administrative and technical support to the project team. This includes ensuring files are reviewed according to the organization’s SOPs, supporting site activation, and assisting with the development of critical site activation paths. You will collaborate with internal and external stakeholders, represent CRG personnel, and contribute to the strategic needs of feasibility activities. Additionally, you will help onboard and train new staff.

    Essential Functions:

    • Coordinate and complete assigned trial activities as detailed in the task matrix.
    • Perform internal, country, and investigator file reviews, documenting findings in appropriate systems.
    • Ensure tasks are completed on time, within budget, and meet high-quality standards, proactively communicating any risks to project leads.
    • Provide system support (e.g., Activate & eTMF), ensuring databases remain up to date.
    • Perform administrative tasks for assigned trials, including document processing, (e)TMF reviews, and distributing mass communications as needed.
    • Assist with analyzing study metrics, reconciling findings reports, and coordinating non-clinical study supplies.
    • Support study-specific translation materials and perform translation quality checks as required.
    • Maintain knowledge of SOPs, regulatory guidelines, and other relevant documentation for services provided.
    • Assist with site activation, regulatory submissions, and document collection from site personnel for selection and startup activities.
    • Work with the project team on regulatory compliance review packages and site documentation.
    • Help with the scheduling of meetings, preparation of materials, and maintenance of study-specific documentation.
    • Act as a liaison with Global Investigator Services to resolve investigator queries and maintain site information.
    • Contribute to the development of global strategic feasibility processes and best practices.

    Knowledge, Skills, and Abilities:

    • Bachelor’s degree in Life Sciences is preferred.
    • 1-3 years of experience in a CRC or CTC role.
    • Excellent business communication skills.
    • Knowledge of eTMF and ICH GCP guidelines.
    • Strong organizational skills, attention to detail, and ability to handle multiple tasks efficiently.
    • Familiarity with MS Office (Word, Excel, PowerPoint) and clinical trial database systems.
    • Strong customer focus, flexibility in reprioritizing workloads, and ability to work both independently and as part of a team.
    • Self-motivated, with a positive attitude and good interpersonal skills.
    • Proficient in English and local languages as needed.
    • Capable of following work instructions, managing risks, and making decisions independently.

    Location:
    Candidates from Mumbai or nearby locations preferred.

    If you have the skills and are ready to join a dynamic team, apply now!

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