# Clinical Research Associate (CRA) **Company**: Fortrea **Work arrangement**: hybrid **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Warsaw/CRA-I-CRA-II_265799?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_8e08417e-182 ## Description At Fortrea, you'll help advance life-saving therapies and transform the lives of patients around the globe. We are currently proactively engaging with talented CRAs for anticipated upcoming opportunities in FSPx and future growth within our teams. **Summary of Responsibilities:** - Manage clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and Sponsor requirements - Conduct site monitoring responsibilities for clinical trials, including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits - Prepare and implement project plans related to Clinical Monitoring responsibilities - Ensure the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to - Safeguard data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines - Confirm Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial - Guarantee that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements - Ensure adherence to global quality control and CRA performance metrics - Ensure audit readiness at site level - Act in the project role of a Lead CRA as assigned **General On-Site Monitoring Responsibilities:** - Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study - Perform eligibility review, verify that screening, informed consent procedures, and protocol requirements are adhered to according to applicable regulatory requirements - Ensure the integrity of the source data reported by careful source document review - Monitor data for missing or implausible data - Ensure study data completeness, accuracy, consistency, and compliance - Identify deficiencies, deviations, and discrepancies, and initiate corrective action as required - Perform required monitoring tasks in an efficient manner, according to SOPs and established guidelines - Travel, including air travel, may be required and is an essential function of the job - Prepare and submit accurate and timely trip reports - Independently perform eCRF review, 100% source data verification, query generation, and resolution against established data review guidelines - Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation, and site management - Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems - Track IP shipments and supplies, as needed - Track and follow-up on serious adverse events as assigned - Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met - Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned - Attend investigators' meetings, project team meetings, and teleconferences, and others as needed - Present training content for site initiation - Assist with training of new employees **Qualifications (Minimum Required):** - University or college degree, or certification in a related allied health profession from an appropriately accredited institution - Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements - Thorough knowledge of monitoring procedures - Basic understanding of the clinical trial process - Fluent in local office language and in English, both written and verbal **Experience (Minimum Required):** - University or college degree, or certification in a related allied health profession from an appropriately accredited institution - A minimum of 1.5 years of Clinical Monitoring experience - Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines - Ability to work with minimal supervision - Understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives, and follow-up of SAEs - Good planning, organization, and problem-solving abilities - Works efficiently and effectively in a matrix environment **Physical Demands/Work Environment:** - Must be able to sit at a computer for long periods of time - Must be able to use hands to finger, handle, or touch objects, tools, or controls, including a computer keyboard, for up to 8 hours per day - Standard office and/or home working environment - Clinical Research Unit and hospital environment (administrative only) - Risk of eye strain - Will involve outside of normal office hours as required by the role - Travel Requirement is 60% of the time (traveling to study sites) ## Skills ### Required - ICH GCP Guidelines - Clinical Monitoring - Source Document Review - Data Integrity - Regulatory Requirements - English --- Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Warsaw/CRA-I-CRA-II_265799?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)