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    Assistant Cra

    Thermo Fisher Scientific
    0-2 years
    Not Disclosed
    Remote, USA
    10 June 25, 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, 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: Clinical Research Associate (Remote)

    Company: Thermo Fisher Scientific
    Location: Remote (Office-based in some cases)
    Work Schedule: Standard (Mon-Fri)
    Environmental Conditions: Office

    About Thermo Fisher Scientific

    At Thermo Fisher Scientific, we are committed to enabling our customers to make the world healthier, cleaner, and safer through innovative solutions and cutting-edge research. With a global presence and a diverse portfolio of clinical trial services, including laboratory and digital solutions, we strive to improve health outcomes worldwide.

    Summarized Purpose

    The Clinical Research Associate (Remote) performs essential activities on assigned projects, collaborating closely with Remote and On-Site Clinical Research Associates (CRAs) and study Clinical Trial Managers (CTMs). This role supports site preparedness, logistics for monitoring processes, and assists with site management tasks, ensuring adherence to Standard Operating Procedures (SOPs) and regulatory guidelines.

    Key Responsibilities

    • Study and Site Management:

      • Execute study and site management activities as defined in task matrices and project requirements.
      • Complete and document study-specific training and orient on CRG/study-specific systems.

    • Logistical Support:

      • Provide in-house support during pre-study assessments and manage pre-study assessment waivers.
      • Customize Site Informed Consent Forms (ICFs) with site contact details as necessary.

    • Remote Monitoring and Compliance:

      • Conduct remote review of Electronic Medical Records (EMR) / Electronic Health Records (EHR) checklists.
      • Support document collection verification and Regulatory Compliance Report (RCR) submission status.

    • Support Functions:

      • Assist in reviewing patient-facing materials and translations as directed.
      • Coordinate vendor-related qualification processes and manage system access for site staff.

    • Site Coordination:

      • Coordinate logistics for Investigator Meetings (IM) attendance and manage study/site supply during activation and subsequent phases.
      • Maintain vendor trackers and support Crucial Document collection and updating in systems.

    • Quality Assurance and Reporting:

      • Conduct ongoing remote reviews of centralized monitoring tools and support site payments processes.
      • Perform reconciliation tasks including CRF and query status, deviations, and safety reports.

    • Task Management and Collaboration:

      • Verify document collection status in CRG systems and take action on incomplete or expired documents.
      • Perform other site management tasks as directed by the Remote CRA and per the Task Matrix.

    • Administrative Responsibilities:

      • Complete administrative tasks such as expense reports and timesheets promptly and accurately.

    Keys to Success

    Education and Experience:

    • Bachelor's degree or equivalent in a relevant field.
    • Previous experience (0 to 2 years) providing knowledge, skills, and abilities to perform effectively.

    Knowledge, Skills, and Abilities:

    • Proficiency in medical/therapeutic areas and understanding of medical terminology.
    • Strong grasp of ICH GCP guidelines, applicable regulations, and CRG procedural documents.
    • Effective communication skills (oral and written), with excellent interpersonal and customer service abilities.
    • Exceptional time management skills, attention to detail, and ability to manage multiple tasks efficiently.
    • Flexibility to work independently or in a team, with critical thinking skills for problem-solving.
    • Digital literacy including MS Office proficiency and adaptability to learn new software as required.

    Benefits

    • Competitive remuneration and annual incentive plan bonus.
    • Comprehensive healthcare benefits and a range of employee perks.
    • Opportunities for career advancement and professional development in an innovative, inclusive organization.

    How to Apply

    Interested candidates who meet the qualifications are encouraged to apply through our website at Thermo Fisher Scientific Careers.

    Join Thermo Fisher Scientific in accelerating research, solving scientific challenges, and supporting global health initiatives. Embrace a culture of integrity, intensity, innovation, and involvement as part of our diverse team committed to making a difference.

    Note: Thermo Fisher Scientific is an Equal Employment Opportunity/Affirmative Action Employer and values diversity in its workforce. Accommodations are available for individuals with disabilities in the application process upon request. For assistance, please contact 1-855-471-2255, reserved for disability-related accommodation inquiries.

    This job description provides an overview and may include additional responsibilities and qualifications as needed by Thermo Fisher Scientific.

     

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