FSO CRA II (Beijing/Tianjin/Shenyang/Changchun/Zhengzhou/Shijiazhuang/Jinan/Harbin/Xi'an/Taiyuan)
On-site · Beijing, Beijing, China
Job Summary
Lead CRA responsibilities across multiple Chinese locations for Fortrea’s clinical trials, focusing on site management and monitoring per SOPs and ICH GCP. Responsible for site monitoring activities including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits; verify informed consent procedures and protocol adherence; ensure data integrity through source document review and SDV; maintain complete and current site regulatory documents and eTMF/sponsor materials; monitor Investigational Product inventory and secure storage; ensure audit readiness at site level; perform 100% eCRF review and issue resolution; assist with training and coordination of study team; travel up to 60% to study sites; work with cross-functional teams to meet timelines and deliverables; fluent in local language and English; strong organizational, problem-solving, and communication skills.
Required Qualifications
- 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.
- A minimum of 2 years of Clinical Monitoring experience (External Candidates).
- Internal Candidates: minimum of 2 years of Clinical Monitoring experience.
Desired Qualifications
- 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
- Minimum of 2 years of Clinical Monitoring experience (External Candidates)
- Internal Candidates: minimum of 2 years of Clinical Monitoring experience
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