# Clinical Research Associate **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/Xian/FSP-CRA-II--Lanzhou-_266022?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_78605f2b-3db ## Description We are seeking a Clinical Research Associate to join our team. As a Clinical Research Associate, you will have site management responsibility for clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and applicable project plans and Sponsor requirements. Responsibilities: - 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 alongside applicable regulatory requirements - 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 as 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 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 - Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner - 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: - 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: - A minimum of 2 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 Preferred Qualifications: - Thorough working knowledge of Fortrea SOPs for site monitoring - One or more additional years of experience in a related field - Phase I monitoring experience - Life Science or Nursing qualification - Specific skills, systems, certifications, and/or licenses preferred - Personal characteristics such as leadership, problem-solving, and interpersonal skills - Good attention to detail - Methodical approach to work - Good understanding of medical and clinical research terminology and clinical research processes - Understanding of the basics of physiology, pharmacology, and medical devices - Good computer literacy with working knowledge of PCs, Windows, and Microsoft Office applications - Good oral and written internal and external communication - Strong interpersonal team and organizational skills - Ability to maintain confidentiality of data and information - Demonstrated ability to conduct clinical operations activities effectively and efficiently - Good analytical and negotiation skills - Experience using e-clinical systems 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 (travelling to study sites) ## Skills ### Required - ICH GCP Guidelines - Clinical Monitoring - Regulatory Requirements - Data Integrity - Source Document Review ### Nice to have - Fortrea SOPs - Phase I monitoring - Life Science or Nursing qualification - e-clinical systems - Leadership - Problem-solving - Interpersonal skills --- Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Xian/FSP-CRA-II--Lanzhou-_266022?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)