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    FO

    Fortrea

    Clinical Research

    CRA II/ Senior CRA, Denmark

    Soborg, DenmarkRemoteFull-timePosted 2mo ago
    All Fortrea jobs

    Job description

    Join Fortrea as a CRA – exciting future opportunities for a single sponsor

    We’re excited to invite CRAs to join Fortrea, where you’ll work with one dedicated sponsor.

    Key requirement:

    • Minimum 2 years of clinical monitoring experience

    • Experience in oncology studies preferred

    Summary of Responsibilities

    • Manage clinical trial sites in line with Fortrea SOPs, ICH GCP and sponsor requirements

    • Perform all monitoring visits (PSV, SIV, routine, close-out)

    • Ensure patient safety by verifying informed consent and protocol adherence

    • Maintain data integrity through SDV, query management, and data review

    • Keep site regulatory documentation and eTMF up to date

    • Oversee investigational product handling, storage, and accountability

    • Ensure audit readiness and compliance with quality standards and CRA metrics

    • Prepare monitoring plans, visit reports, and study documentation

    On-site Monitoring Responsibilities

    • Ensure site staff are trained and equipped to run the study

    • Verify subject eligibility, consent, and protocol compliance

    • Review source data for accuracy and completeness

    • Identify and resolve data discrepancies and deviations

    • Perform efficient monitoring activities in line with SOPs and travel policy

    • Submit timely and accurate visit reports

    • Track study progress, IP shipments, and serious adverse events

    • Collaborate closely with study teams to meet timelines and deliverables

    Additional Responsibilities

    • Support investigator/site management activities

    • Work with CTMS and other eClinical systems

    • Attend investigator meetings and project calls

    • Deliver site training and support onboarding of new team members

    • Contribute to study planning and monitoring strategy

    Qualifications & Experience

    • Degree in life sciences or related field (or equivalent experience)

    • Strong knowledge of ICH GCP and clinical trial processes

    • Minimum 2 years of clinical monitoring experience

    • Ability to monitor independently with minimal supervision

    • Experience with SAE reporting and clinical data review

    • Strong organizational, problem-solving, and communication skills

    Learn more about our EEO & Accommodations request here.

    Job details are sourced from the employer's original posting.

    Open job posting
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    About the company

    Fortrea

    Fortrea is a company that provides clinical trial and research services.

    View all Fortrea jobs
    Industry
    Clinical Research
    Open roles
    215

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