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    Cra Ii

    Fortrea
    2+ years
    Not Disclosed
    Remote - Europe
    10 Oct. 30, 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

    Company Overview

    Fortrea is a leading global contract research organization (CRO) committed to scientific rigor and decades of clinical development experience. We provide a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in over 90 countries, we are transforming drug and device development for partners and patients worldwide.

    Job Overview

    This posting is for upcoming future opportunities at Fortrea for Clinical Research Associates (CRAs). The CRA will be responsible for site management and monitoring for clinical studies, ensuring compliance with Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, and project-specific requirements.

    Key Responsibilities

    • Site Management: Oversee clinical study operations, ensuring adherence to protocols and regulatory requirements, including verification of training records.
    • Monitoring Duties: Conduct all monitoring activities, including Pre-study, Site Initiation, Routine Monitoring, and Close-out Visits, in accordance with Fortrea SOPs and ICH guidelines.
    • Project Planning: Prepare and implement project plans related to clinical monitoring responsibilities.
    • Subject Protection: Ensure informed consent procedures and protocol compliance to protect study subjects.
    • Data Integrity: Review source documents, verify data accuracy, and resolve discrepancies to safeguard data integrity.
    • Regulatory Compliance: Confirm that all site regulatory documents and eTMF/Sponsor documents are complete and current throughout the trial.
    • Inventory Management: Ensure accurate accountability of the Investigational Product inventory and secure storage of study materials.
    • Quality Control: Adhere to global quality standards and CRA performance metrics, ensuring audit readiness at the site level.
    • Lead CRA Role: Act as Lead CRA on projects as assigned.

    General On-Site Monitoring Responsibilities

    • Staff Training: Ensure study staff are equipped with proper materials and instructions for subject enrollment and protocol adherence.
    • Data Monitoring: Conduct thorough source data verification and monitor for missing or implausible data.
    • Efficiency: Perform monitoring tasks efficiently while managing travel expenses in accordance with Fortrea’s travel policy.
    • Reporting: Prepare and submit accurate trip reports in a timely manner.
    • eCRF Review: Independently perform eCRF reviews and generate queries as needed.
    • Collaboration: Work closely with study teams to align monitoring with critical timelines and deliverables.
    • Training Sessions: Prepare training content for site initiation and assist in training new employees.
    • Additional Duties: Complete other responsibilities as assigned by management.

    Qualifications (Minimum Required)

    • University or college degree or certification in a related health profession (e.g., nursing licensure) or equivalent experience.

    Experience (Minimum Required)

    • A minimum of 2 years of Clinical Monitoring experience.
    • Mandatory CRA certification as per Ministerial Decree.
    • Thorough understanding of ICH GCP Guidelines and local regulatory requirements.

    Physical Demands / Work Environment

    • Ability to sit at a computer for extended periods and use hands for typing and handling objects.
    • Standard office and clinical research unit environments with potential travel requirements (up to 60% of the time).

    Join Us

    Fortrea is seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our commitment to revolutionizing the development process ensures the swift delivery of life-changing therapies to patients. Join our exceptional team and thrive in a collaborative workspace that nurtures personal growth and enables you to make a meaningful global impact.

    Equal Opportunity Employer

    Fortrea is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of individuals without discrimination based on race, religion, gender, sexual orientation, age, or any other legally protected characteristic. We encourage all to apply.

    For more information about how we collect and store your personal data, please see our Privacy Statement.

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