Clinical Research Associate II

Location: Shanghai, China

Company

hirify.global develops innovative medicines and solutions across areas including immunology, oncology, neuroscience, and aesthetics.

What you will do

• Serve as the primary sponsor point of contact for investigative sites and build effective relationships with investigators and site staff.
• Conduct site evaluation, training, routine on-site and off-site monitoring, and site closure activities in accordance with protocols, monitoring plans, GCP, ICH guidelines, regulations, and hirify.global procedures.
• Align, train, motivate, and mentor site personnel and support junior CRAs in site management activities.
• Develop site engagement, patient recruitment, and retention strategies based on the protocol, therapeutic area, and patient journey.
• Perform continuous risk assessment with Central Monitoring, resolve site risk signals, and implement corrective and preventive actions.
• Ensure data quality, timely safety reporting, audit and inspection readiness, investigator site selection, and investigator payments where applicable.

Requirements

• At least 3 years of clinically related experience, including preferably 2 years of independent monitoring of investigational drug or device trials.
• Experience with risk-based monitoring and both on-site and off-site monitoring.
• Relevant tertiary qualification in medicine, science, pharmacy, nursing, or another health-related discipline preferred.
• Knowledge of therapeutic-area science, local regulatory and legal requirements, ICH/GCP guidelines, and applicable policies.
• Advanced communication, presentation, planning, organizational, interpersonal, critical-thinking, and cross-functional collaboration skills.
• Ability to work independently, manage competing deadlines, use clinical research technology and tools, and maintain integrity in accordance with hirify.global values.

Culture & Benefits

• Work focuses on advancing clinical research and turning scientific discoveries into medicines for patients.
• Collaboration spans study teams, internal R&D stakeholders, investigators, and clinical site staff.
• Opportunities to participate in or lead global and local task forces and initiatives.
• Equal opportunity employment and a stated commitment to integrity, innovation, community service, and inclusion.