Clinical Research Associate (CRA)

We are seeking a proactive and detail-oriented Clinical Research Associate (CRA) to join our growing China Clinical Operations team. This role will be responsible for on-site and remote monitoring and management of one or more clinical trial sites in China, ensuring compliance with the study protocol, standard operating procedures (SOPs), ICH-GCP, China GCP, and applicable Chinese regulatory requirements, including NMPA and local ethics committee requirements. The successful candidate will be a key member of the clinical operations team, working closely with investigators, site staff, vendors, and cross-functional study team members to support high-quality study delivery and inspection readiness.

• Perform all aspects of site management through onsite and remote monitoring visits, including site selection, initiation, routine monitoring, and close-out.
• Support site start-up activities, including feasibility support, ethics committee submission follow-up, site contract and budget coordination, essential document collection, site activation readiness, and investigator site file set-up.
• Ensure the protection of study subjects by verifying that informed consent procedures and protocol compliance are followed.
• Conduct source data verification (SDV) to assess the accuracy, completeness, and reliability of clinical data reported in case report forms (CRFs).
• Review the management of investigational product (IP) accountability, storage, and reconciliation at sites.
• Identify, track, and ensure resolution of site issues, protocol deviations, and adverse events.
• Complete monitoring visit reports and follow-up letters in a timely manner.
• Maintain and update trial master file (TMF) documents to ensure audit readiness.
• Develop and maintain strong, collaborative relationships with investigators and site staff.
• Provide ongoing protocol and study process training to site personnel.
• Report on site status, patient recruitment, and data issues to the clinical team.
• Ensure all site activities comply with ICH-GCP, China GCP, company SOPs, study plans, and applicable Chinese regulatory and ethics committee requirements.
• Perform other study activities as assigned by the line manager.

• University bachelor degree or above in Life Sciences, Pharmacy, Nursing, or a related field is required.
• Minimum of 1-3 years of independent on-site monitoring experience as a CRA within a Sponsor or CRO environment, with proven experience in China clinical trials.
• Solid understanding and practical application of ICH-GCP, China GCP, NMPA requirements, ethics committee processes, HGRAC-related requirements where applicable, and local site start-up and monitoring practices.
• Experience supporting China site start-up activities, including ethics committee submission follow-up, contract and budget coordination, site activation readiness, and essential document collection, is preferred.
• Experience in managing site dynamics and building effective site relationships.
• Strong attention to detail, and excellent analytical and problem-solving skills.
• Superior organizational and time management skills with the ability to manage multiple priorities.
• Ability to work both independently and collaboratively within a team.