MAIN PURPOSE OF ROLE

Responsible for overseeing the execution and coordination of clinical study activities at clinical sites, ensuring all procedures are conducted in strict compliance with the study protocol, company standard operating procedures (SOPs), and applicable regulatory requirements, including those set forth by the FDA and NMPA.

MAIN RESPONSIBILITIES

• Participate in the identification and nomination of new clinical trial sites; assess site capabilities and provide recommendations for inclusion in clinical trial. Assist in overseeing clinical study projects to ensure on-time and on-budget execution. Ensure site activities in line with milestones (i.e. startup, recruitment, close-out, etc.).
• Provide support in the drafting and review of essential clinical study documents, including study protocols, case report forms (CRFs), and informed consent forms (ICFs), ensuring compliance with regulatory requirements and scientific standards.

• Manage the submission of ethics committee documents, ensuring timely approval/acknowledgment, and maintain full compliance with applicable regulatory and ethical standards.
• Negotiate and sign the site agreement, manage the application and disbursement of study-related funds in accordance with contractual terms, and ensure timely collection of associated invoices.
• Proactively resolve site issues, respond to questions, and coordinate the provision of additional study materials as needed.
• Conduct site initiation visits (SIVs), routine monitoring visits, and close-out visits, ensuring timely submission of monitoring and study reports in accordance with study timelines.
• Support statistical analysis for IVD analytical performance studies and clinical trials.

Perform additional duties as assigned by management, supporting team and project needs as required.

QUALIFICATIONS

• Master’s degree in Public Health, Medical, Pharmacy or a related field.
• Minimum of 2 years’ experience as a Clinical Research Associate (CRA) in the IVD, pharmaceutical, or CRO industry.
• Solid knowledge and experience in international standards (GCP/ICH), and regulatory requirements from FDA, EMA and NMPA.
• Familiarity with statistical method and software tools.
• Strong communication skills, ability to manage multiple priorities, and proficient in computer applications.

Good command of both written and spoken English.