CRA II, Norway

It is a full-time position supporting a single sponsor.

Role is based in the Oslo area.

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)

Learn more about our EEO & Accommodations request here.