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🔥 2 hours ago

🇨🇳 China – Remote

⏰ Full Time

🟢 Junior

✨ Navigator

🚫👨‍🎓 No degree required

👻 Ghost score 10%

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Coordinate site-level activities throughout clinical study start-up and potentially closeout • Serve as the primary point of contact for investigative sites • Identify and assess potential research sites • Conduct initial site outreach and collect confidentiality agreements and feasibility surveys • Manage site-level activities, resolve issues, and support study timelines and compliance • Conduct remote pre-study visits and complete follow-up documentation • Support customization and translation of informed consent forms and patient-facing materials • Collect, track, and quality-review essential site activation documents • Maintain site regulatory compliance, including IRB/IEC renewals, PI changes, and document expirations • Participate in study team meetings and develop action plans for site risks and issues • Support CRA teams in preparing site initiation visits and coordinating supplies, access, and documents • Liaise with IRB/IEC, Third Bodies, and Regulatory Authorities • Perform initial and amended contract and budget negotiations with sites • Maintain accurate filing systems and an audit-ready Trial Master File • Track start-up progress and site requirements and deadlines • Ensure ongoing system compliance and audit readiness • Deliver timely site support within scope of work and study budget • Perform CRF review and source-data validation, and monitor protocol deviations and SAE reporting • Perform country and site informed-consent-form review and customization • Perform other assigned duties

🎯 Requirements

• University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution, or 2–3 years' work experience in clinical research • Relevant and equivalent experience may be considered in lieu of educational requirements • High School Diploma or equivalent and a minimum of 5 years' work experience in clinical research may substitute for the above requirement • Working knowledge of ICH/GCP guidelines and RA, IRB/IEC regulations • Fluent in the local official language and English, written and verbal • At least one year of experience in a related field • Basic knowledge of ICH/GCP, RA, IRB/IEC, and applicable regulations/guidelines • Familiarity with investigator start-up documents and contract/budget negotiation processes • Understanding of research protocol requirements • Ability to manage multiple tasks and deadlines simultaneously • Ability to identify and resolve potential issues during the start-up process • Ability to negotiate contracts and budgets with research sites • Effective communication with site staff, CRO personnel, and regulatory authorities

🏖️ Benefits

• Remote-based work required with possible office presence depending on location • Limited travel, only for training • EEO & accommodations support