CRA II, Norway
Fortrea
Oslo
Full-time
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This role is for upcoming future opportunities that may arise at Fortrea.
It is a full\-time position supporting a single sponsor.
Role is based in the Oslo area.
Key requirement:
- Minimum 2 years of clinical monitoring experience
- Preferably 1\+ year experience in oncology studies
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
- 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
Additional Information* Willingness to travel (\~60% to study sites)
Learn more about our EEO \& Accommodations request here .
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