What You'll Do
Oversee monitoring activities at clinical trial sites, including pre-study, initiation, routine, and closeout visits. Ensure study teams follow protocols and regulatory standards, and confirm informed consent processes are properly documented.
Review source documents and Case Report Forms to maintain data accuracy, identify missing or inconsistent entries, and resolve queries in line with established guidelines. Prepare detailed trip reports and support audit readiness at all sites.
Act as a lead monitor or local project coordinator for assigned protocols, guiding project timelines and contributing to monitoring plans. Coordinate with vendors, manage trial supplies, and assist in preparing submissions to ethics committees and regulatory agencies.
Support protocol and CRF development, contribute to clinical study reports, and participate in investigator meetings by organizing logistics and delivering presentations. Assist in training junior staff and co-monitoring activities to build team capability.
Requirements
- University or college degree in life sciences or a related health field, or minimum of three years of clinical research experience in pharmaceuticals or CRO settings
- Fluency in English and the local office language, both written and spoken
- At least three years of clinical monitoring experience, including full understanding of SAE reporting and follow-up procedures
- Demonstrated knowledge of regulatory requirements across regions and the drug development lifecycle
- Strong computer literacy and experience with various software applications
- Proven ability to manage work independently, prioritize tasks, and supervise junior team members
- Excellent communication, problem-solving, and organizational skills
- Valid driver’s license
Benefits
This role supports professional growth through project leadership opportunities, cross-functional collaboration, and involvement in diverse stages of clinical development. You will work within a structured, compliant environment that values precision, accountability, and continuous learning.
Work Mode
This is an onsite position based in Harbin, Shenyang, or Changchun. Regular travel to clinical sites is required, including air and ground transportation as needed for monitoring duties.
