CRA I - Beijing
Hybrid · Beijing, Beijing, China
Job Summary
Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, informed consent forms, and case report forms. Develop and implement tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and templates. Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of standard operating procedures (SOPs) and training materials. Manage defined components of projects or processes within the area of responsibility, such as coordinating site visits, tracking study progress, and resolving issues. Ensure accurate and timely documentation of monitoring activities and findings, including writing monitoring reports, follow-up letters, and action plans. Collaborate with cross-functional teams to support clinical trial operations, including working with investigators, site staff, and other stakeholders to ensure smooth study conduct.
Required Qualifications
- Bachelor's degree in a related field or equivalent experience
- Minimum of 2-4 years of experience in clinical research monitoring
- Certified Clinical Research Associate (CCRA) or equivalent certification preferred
- Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
- Ability to work independently and manage multiple priorities
- Proficiency in using clinical trial management systems and other relevant software
- Excellent communication and interpersonal skills
- Attention to detail and strong analytical skills
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