CRA II - Sponsor dedicated

Fortrea; Søborg; On-site; DKK 500,000 - 700,000; Full time

Job summary

Fortrea is seeking a Clinical Research Associate (CRA) for on-site monitoring, focusing on site management and compliance with ICH GCP. The role requires at least two years of clinical monitoring experience and a degree in life sciences or a related field.

The CRA will conduct PSV, SIV, and routine visits, ensure patient safety through informed consent checks, and maintain regulatory documents. Travel to study sites ~60% is expected.

Qualifications

• 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.

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: verify subject eligibility, consent, and protocol compliance.
• Review source data for accuracy and completeness.
• Identify and resolve data discrepancies and deviations.
• Submit timely and accurate visit reports.
• Track study progress, IP shipments, and serious adverse events.
• Collaborate with study teams to meet timelines and deliverables.
• 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.

Skills

Clinical monitoring experience

Study site management

Data integrity

GCP knowledge

Communication skills

Education

Life sciences degree

Tools

CTMS

eTMF systems

SAE reporting tools

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
• 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)

Learn more about our EEO & Accommodations request here.