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Clinical Research Associate II
1 month ago
Fortrea is seeking a highly motivated and detail-oriented Clinical Research Associate II to join our team in Chengdu. As a key member of our clinical operations team, you will be responsible for ensuring the integrity of clinical trials and providing high-quality support to our clients.
Key Responsibilities- Conduct routine monitoring and close-out of clinical sites, including maintenance of study files and conduct of pre-study and initiation visits.
- Liaise with vendors and other stakeholders to ensure timely and efficient completion of study tasks.
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements.
- Monitor data for missing or implausible data and ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools.
- Prepare accurate and timely trip reports and ensure audit readiness at the site level.
- Participate in and follow up on Quality Control Visits (QC) and undertake feasibility work when requested.
- Recruitment of potential investigators, preparation of EC submissions, notification to regulatory authorities, translation of study-related documentation, organization of meetings, and other tasks as instructed by supervisor.
- Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives, and follow-up of SAE.
- Independently perform CRF review, query generation, and resolution against established data review guidelines on Labcorp Drug Development or client data management systems as assigned by management.
- Assist with training, mentoring, and development of new employees, e.g., co-monitoring, and coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable).
Fortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
We are committed to revolutionizing the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. If you are a motivated problem-solver and creative thinker who shares our passion for overcoming barriers in clinical trials, we encourage you to apply for this exciting opportunity.
