CRA II, Norway
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Job Summary
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
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
Additional Information
Willingness to travel (60% to study sites)
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