# Clinical Research Associate **Company**: Fortrea **Location**: Chengdu **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Chengdu/Core-CRA--Chengdu-Chongqing-_265060?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_78795ed0-27d ## Description We are seeking a Clinical Research Associate to join our team in Chengdu. As a Clinical Research Associate, you will be responsible for site management and monitoring of clinical trials. ### Summary of Responsibilities 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. This includes verification of study training records. Key responsibilities include: - 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 alongside applicable regulatory requirements - 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 ### General On-Site Monitoring Responsibilities You will ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. You will also: - Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the 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, according to SOPs and established guidelines ### Qualifications To qualify for this role, you will need: - A university or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure) - 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 We require a minimum of 2 years of Clinical Monitoring experience. You should also have: - 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 ### Physical Demands/Work Environment This role requires: - Sitting at a computer for long periods of time - Using 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) ### Benefits We offer a competitive salary and benefits package. ## 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/Chengdu/Core-CRA--Chengdu-Chongqing-_265060?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)