Clinical Research Associate

Apsida Life Science have partnered with a leading patient recruitment company to present the following role: Clinical Research AssociateDuration : 12 monthsCompany Overview: The client company specializes in the delivery of accelerated patient recruitment. The client works with study teams to deliver professional, tailor made solutions to help clinical trials be delivered on time, within budget and to the required standard. Key Responsibilities: Monitor clinical trial sites to ensure adherence to study protocols, GCP, ICH guidelines, and local regulatory requirements. Perform site qualification, initiation, monitoring, and close-out visits. Maintain accurate and complete documentation for trial monitoring visits.

Ensure timely collection and review of essential documents and trial data. Identify and resolve site performance issues in collaboration with site staff and internal stakeholders. Provide training and guidance to investigators and site coordinators on study conduct and procedures. Communicate with cross-functional teams including clinical operations, data management, and regulatory affairs. Assist with ethics committee submissions, regulatory filings, and safety reporting. Contribute to study startup, feasibility, and patient recruitment strategies. Support audits and inspections at clinical trial sites. Qualifications: Bachelor’s degree or higher in Life Sciences, Pharmacy, Medicine, Nursing, or a related field.

Minimum 1–3 years of monitoring experience in clinical trials (CRA role) within the pharmaceutical or CRO industry. Strong understanding of GCP, ICH guidelines, and Chinese regulatory requirements (e. g. , NMPA). Experience working with clinical documentation and electronic data capture (EDC) systems. Excellent organizational and time management skills. Strong verbal and written communication skills in both Mandarin Chinese and English