Senior Clinical Research Associate (Medical Device/IVD)

Location: Beijing, China

Company

hirify.global develops analytical, diagnostic, and laboratory technologies, including solutions used in medical device and IVD research.

What you will do

• Schedule and conduct pre-study, initiation, interim monitoring, and close-out visits according to monitoring plans.
• Monitor assigned sites for compliance with protocols, SOPs, Good Clinical Practice, and applicable regulations.
• Verify source documents, case report forms, and electronic data capture entries for accuracy, completeness, and traceability.
• Ensure appropriate investigator site management, including subject eligibility, facility adequacy, investigational product accountability, and documentation.
• Communicate protocol and quality deviations, support corrective actions, and deliver monitoring reports and follow-up correspondence on time.
• Participate in site audits, feasibility assessments, monitoring guideline development, and studies supported by other business units.

Requirements

• Bachelor’s, master’s, university degree, or equivalent qualification.
• At least 3 years of clinical research associate experience in a multinational pharmaceutical, medical device, or CRO organization.
• Professional experience with medical device or IVD clinical trials.
• Familiarity with clinical trial quality management systems and applicable clinical research regulations.
• Education or specialization in clinical medicine or pharmacy; pathology experience is an advantage.
• Good English skills and willingness to travel domestically approximately 10% of the time.

Culture & Benefits

• Full-time employment with a daytime schedule.
• Compensation and benefits are determined by role, level, work location, skills, experience, and education.
• No fixed end date for the position.
• Equal employment opportunity under applicable laws.