other
Posted May 6CRA II, Denmark
at Fortrea
On-site
Responsibilities
- 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
Requirements
- experience in oncology studies Summary of
- 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 .
Experience
- Key requirement: Minimum 2 years of clinical monitoring experience Preferably 1+ year
Additional details
- This role is for upcoming future opportunities that may arise at Fortrea.
- Join Fortrea as a CRA – exciting future opportunities across multiple sponsors We’re excited to invite CRAs to join Fortrea, where you’ll work on a diverse portfolio of studies across multiple sponsors.
- This role offers strong exposure to different therapeutic areas, high-quality standards, and the opportunity to further develop your monitoring expertise in a global environment.
- Responsibilities Manage clinical trial sites in line with Fortrea SOPs, ICH GCP and sponsor
- 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