Senior Clinical Research Associate

Location: Taiwan, Taipei; remote, field based. Significant travel of 60–80% within the assigned area is required, with possible international and weekend travel.

Company

hirify.global conducts clinical development activities in accordance with applicable regulations, Good Clinical Practices, and internal standards.

What you will do

• Manage and monitor assigned investigator sites from site initiation through routine monitoring, database lock, and close-out.
• Ensure clinical trials follow the Study Monitoring Plan, applicable laws, ICH/GCP requirements, and hirify.global standards.
• Act as the primary contact for investigator sites, facilitating communication with study teams, vendors, Site Care Partners, and investigators.
• Support site development, protocol training, recruitment, enrollment, patient safety, and resolution of protocol-related issues.
• Monitor adverse and serious adverse events, investigational product handling, documentation, data queries, and required trial reporting.
• Drive issue remediation, CAPA activities, audit support, database release, and co-monitoring; mentor Clinical Research Associates and serve as a process SME.

Requirements

• Bachelor’s or professional degree in life sciences, nursing, pharmacy, medicine, or an equivalent field.
• At least 5 years of relevant clinical research site-monitoring experience, preferably including 3 years in oncology.
• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA requirements, and local country regulations.
• Experience with global clinical trials and a strong understanding of clinical research operations, risk management, protocol feasibility, and regulatory inspections.
• Fluency in both English and Mandarin is required.
• Valid driver’s license and passport required; ability to travel extensively within the assigned area.

Nice to have

• Therapeutic experience in oncology, vaccines, internal medicine, or infectious diseases.
• Experience supporting sponsor regulatory interactions and inspections.

Culture & Benefits

• Remote, field-based work arrangement.
• Collaboration with Site Care Partners, Country Study Operations Managers, clinicians, recruitment specialists, clinical data scientists, and other study team members.
• Opportunities to mentor Clinical Research Associates and participate in regional or local process-improvement initiatives.
• Work may include international and weekend travel depending on study requirements.