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    Clinical Trial Coordinator Ii - Etmf

    Thermo Fisher Scientific
    3-5 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

    Job Description

    Summarized Purpose:

    As an integral part of the Project Team, you will provide both administrative and technical support. Your role will involve ensuring audit readiness by adhering to the schedule detailed in the organization's SOP and department guidance documents. You will support site activation activities, contribute to the development of critical paths for rapid site activation, and represent CRG personnel. Your responsibilities will include leveraging local knowledge, organization systems, external site lists, and sponsor directives to develop and review site lists. Additionally, you may provide onboarding support and training to new staff.

    Essential Functions:

    • Coordinate and oversee functions on assigned trials as detailed on the task matrix (Central or Local role).
    • Conduct department, internal, country, and investigator file reviews, documenting findings in the appropriate systems.
    • Ensure tasks are completed on time, within budget, and to high-quality standards; proactively communicate any risks to project leads.
    • Provide system support (e.g., Activate & eTMF) and maintain up-to-date system databases.
    • Perform administrative tasks related to trials, including processing documents, performing eTMF reviews, and distributing communications.
    • Analyze and reconcile study metrics and findings reports; assist with resolving site documentation issues.
    • Coordinate and compile Investigator Site File (ISF) and Pharmacy binder materials; manage non-clinical study supplies.
    • Assist with study-specific translation materials and quality control of translations.
    • Maintain knowledge of SOPs, client SOPs/directives, and current regulatory guidelines relevant to services provided.
    • Support feasibility visits (Asia Pac only) and scheduling of client/internal meetings.
    • Review and track local regulatory documents as needed; provide system support and support RBM activities.
    • Support the maintenance of study-specific documentation and systems, including training requirements and project activity plans.
    • Transmit documents to clients and centralized IRB/IEC; maintain vendor trackers.
    • Assist with regulatory submissions and site selection documentation.
    • Collaborate with internal departments to ensure site startup activities align with the critical path.
    • Complete the 'Site Interest Plan' in CTMS and manage document collection and delivery from investigators and site personnel.
    • Document real-time communication and follow-up with site contacts and survey responses.
    • Collaborate with teammates to meet targeted deadlines and address site issues and risks.
    • Ensure efficient site contact plans and escalate concerns/non-compliance to management.
    • Act as a local expert on site capacity and experience, contributing to site tiering and recommendations.
    • Liaise with Global Investigator Services to resolve investigator queries and maintain account/contact information.
    • Contribute to global strategic feasibility processes and best practices.
    • Train new personnel in processes and systems and use local knowledge to identify and develop new sites.

    Knowledge, Skills, and Abilities:

    • Bachelor’s Degree in Life Science preferred.
    • 3-5 years of experience in eTMF activities.
    • Excellent business communication skills.
    • Strong knowledge of eTMF and ICH GCP activities.
    • Immediate availability preferred.
    • Ability to work independently or as part of a team.
    • Strong organizational skills, attention to detail, and multitasking ability.
    • Proficiency in analyzing project-specific data/systems for accuracy and efficiency.
    • Strong customer focus with flexibility to adjust to changing project timelines.
    • Understanding of Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.
    • Proficient in English and local languages as needed; skilled in MS Office (Word, Excel, PowerPoint) and clinical trial database systems.
    • Ability to complete the organization's clinical training program.
    • Self-motivated with a positive attitude and strong interpersonal skills.
    • Effective oral and written communication skills.
    • Good negotiation skills, independent thinking, risk management, and decision-making abilities.

    Work Schedule:

    • Standard (Mon-Fri)

    Environmental Conditions:

    • Office-based

    This role offers an excellent opportunity to support and enhance project management processes within a dynamic and supportive environment.

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