CRA II - Sponsor dedicated
PharmaCROClinical Research
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 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 .
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