Role Overview
A Senior Clinical Research Associate will lead monitoring and site management activities across international clinical trials, ensuring adherence to ICH-GCP, local regulations, and internal SOPs. This position plays a central role in maintaining data quality, patient safety, and regulatory compliance while supporting Clinical Trial Managers and contributing to study documentation and team development.
Key Responsibilities
- Lead all phases of site management, from feasibility and start-up to close-out, ensuring timely regulatory submissions and compliance with ethics committees and regulatory authorities.
- Conduct pre-study, initiation, monitoring, and close-out visits independently, both on-site and remotely, in alignment with study protocols and monitoring plans.
- Verify informed consent procedures, investigational product accountability, and protocol adherence at each site.
- Review and maintain Investigator Site Files, ensuring alignment with Trial Master File requirements and archiving standards.
- Generate and submit detailed monitoring reports, follow-up letters, and communication logs in accordance with SOPs and client expectations.
- Support audit readiness by preparing sites and contributing to responses to findings, including follow-up actions.
- Monitor clinical data integrity through source document review, EDC query resolution, and ongoing data trend analysis.
- Identify and escalate site-level risks related to safety, compliance, or data quality, proposing mitigation strategies.
- Assist in the development of study tools, training materials, and monitoring plans, and may contribute to protocol and CRF reviews.
- Mentor junior monitors and support onboarding and training initiatives within the clinical team.
- Coordinate investigator payments and support contract processes in collaboration with designated departments.
- Attend sponsor meetings, investigator conferences, and team trainings as required by the study schedule.
- Travel frequently (60–70%) to clinical sites across mainland China and potentially other regions based on project demands.
Qualifications
- Bachelor’s degree or equivalent in a scientific, healthcare, or business-related field.
- Minimum of 3.5 years of direct on-site monitoring experience, with a strong background in oncology trials.
- Proven experience in global clinical trial execution and familiarity with international regulatory environments.
- Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint) and Electronic Data Capture (EDC) systems.
- Fluent in English, both written and spoken, with strong attention to detail and accuracy.
- Demonstrated understanding of ICH-GCP, SOPs, and the clinical drug development process.
- Ability to work independently and collaboratively in a remote setting with excellent organizational skills.
Work Environment
This is an onsite role based in Shanghai or Beijing, with extensive travel (60–70%) required across clinical sites. The position supports a science-driven organization focused on advancing research in oncology and rare diseases through rigorous clinical execution and data excellence.
