# Clinical Research Associate **Company**: Fortrea **Location**: Shanghai **Work arrangement**: onsite **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Shanghai/CRA-I-II-Senior--Shanghai-_256261?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_8d8c2710-b14 ## Description Fortrea is seeking a Clinical Research Associate to manage clinical studies according to their Standard Operating Procedures, ICH GCP Guidelines, and Sponsor requirements. The successful candidate will be responsible for: - Conducting site monitoring responsibilities for clinical trials, including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits - Preparing and implementing project plans related to Clinical Monitoring responsibilities - Ensuring the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to - Safeguarding data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines - Confirming Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial - Guaranteeing that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements - Ensuring adherence to global quality control and CRA performance metrics - Ensuring audit readiness at site level - Acting in the project role of a Lead CRA as assigned The ideal candidate will have: - A university or college degree, or certification in a related allied health profession - Thorough understanding of ICH GCP Guidelines and 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 - At least 2 years of Clinical Monitoring experience Preferred qualifications include: - 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 The role involves 60% travel to study sites, and the ability to work independently with minimal supervision. **Qualifications (Minimum Required)** - University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate. - 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. - Fortrea may consider relevant and equivalent experience in lieu of educational requirements. **Experience (Minimum Required)** - External Candidates: University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). AND A minimum of 2 years of Clinical Monitoring experience. - Internal Candidates: Internal candidates with 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. - Have an 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 ### Nice to have - Fortrea SOPs - Phase I monitoring experience - Life Science or Nursing qualification - e-clinical systems --- Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Shanghai/CRA-I-II-Senior--Shanghai-_256261?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)