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Fortrea

CRA II - Sponsor dedicated

LocationSoborg
Work moderemote
Typefull-time
Company size10,000+ people
First seen2w ago
Last seen4d ago
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
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Manage clinical trial sites in line with Fortrea SOPs, ICH GCP and sponsor requirements
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Perform all monitoring visits (PSV, SIV, routine, close-out)
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Ensure patient safety by verifying informed consent and protocol adherence
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Maintain data integrity through SDV, query management, and data review
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Keep site regulatory documentation and eTMF up to date
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Oversee investigational product handling, storage, and accountability
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Ensure audit readiness and compliance with quality standards and CRA metrics
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Prepare monitoring plans, visit reports, and study documentation
On-site Monitoring Responsibilities
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Ensure site staff are trained and equipped to run the study
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Verify subject eligibility, consent, and protocol compliance
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Review source data for accuracy and completeness
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Identify and resolve data discrepancies and deviations
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Perform efficient monitoring activities in line with SOPs and travel policy
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Submit timely and accurate visit reports
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Track study progress, IP shipments, and serious adverse events
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Collaborate closely with study teams to meet timelines and deliverables
Additional Responsibilities
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Support investigator/site management activities
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Work with CTMS and other eClinical systems
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Attend investigator meetings and project calls
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Deliver site training and support onboarding of new team members
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Contribute to study planning and monitoring strategy
Qualifications & Experience
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Degree in life sciences or related field (or equivalent experience)
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Strong knowledge of ICH GCP and clinical trial processes
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Minimum 2 years of clinical monitoring experience
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Ability to monitor independently with minimal supervision
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Experience with SAE reporting and clinical data review
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Strong organizational, problem-solving, and communication skills
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