FSP CRA II/SCRA (Hangzhou) Cell Therapy
On-site · Hangzhou, Zhejiang, China
Job Summary
Site management and clinical monitoring leadership for Fortrea-supported trials in Hangzhou, ensuring adherence to ICH GCP, SOPs, and regulatory requirements; performing eligibility review, informed consent verification, source data verification, SAE tracking, IP inventory control, eTMF/Sponsor document maintenance, and trial data quality; developing and executing monitoring plans, conducting site initiation and routine monitoring visits, and maintaining audit readiness; training and mentoring staff, coordinating with investigators, and managing travel as required (approximately 60% travel). Proficiency in English and local language, nursing licensure or equivalent degree/certification, and prior clinical monitoring experience are preferred. Extends expertise to eClinical systems (eCRF/CTMS) and data management practices to ensure data integrity and compliance throughout the study lifecycle.
Required Qualifications
- Bachelor or Master degree, or certification in a related allied health profession (e.g., nursing licensure).
- A minimum of 2 years of Clinical Monitoring experience.
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