CRA II - Sponsor dedicated
FTPOL Fortrea Poland Sp z o.o.
Apply to this jobJoin 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
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
Learn more about our EEO & Accommodations request here.
Summary
Manage clinical trial sites, monitor data, ensure compliance, and support study activities.
Job title
CRA II - Sponsor dedicated
Experience level
2+ years
Minimum experience
2+ years exp
Industry
healthcare
Location requirements
Soborg, no remote work specified
Salary
Not specified
Management role
No
Required skills
Preferred skills
Specializations
Structured locations inferred from the posting.
Søborg, Denmark