Inhouse CRA

Novotech; Hong Kong; Hybrid; HKD 197,000 - 246,000; Full time

Job summary

Novotech is seeking an In-house Clinical Research Associate to support the clinical trials lifecycle from start-up through TMF maintenance in Taipei. You will collaborate with Project Managers, CRAs, and the Clinical Operations team to ensure compliance with ICH-GCP, local regulations, and client SOPs, while maintaining strong site communication and documentation.

The role requires 2–3 years in clinical research, proficiency in CTMS/eTMF/EDC systems, and fluency in English and Chinese.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related discipline.
• 2–3 years of experience in clinical research, preferably as a CTA/Coordinator/Study Start-Up Specialist.
• Experience with CTMS, eTMF, EDC and other clinical trial systems is advantageous.

Responsibilities

• Support study start-up activities, including collection and review of essential documents, site activation requirements, and IRB/EC submission documentation.
• Assist CRAs and Project Managers with clinical trial coordination and study tracking activities.
• Maintain and ensure completeness of Trial Master File (TMF/eTMF) documentation throughout the study lifecycle.
• Track site regulatory documents, contracts, and study-related approvals to ensure timely study progress.
• Coordinate communication between study sites, CRAs, Project Managers, and vendors.
• Prepare and maintain study trackers, logs, and reports to monitor study status, enrollment, and site activities.

Skills

English-Chinese communication

Organizational skills

Stakeholder coordination

Multi-tasking

Education

Bachelor's degree in Life Sciences/Related

Tools

CTMS

eTMF

EDC

Job description

The In-house CRA works closely with the Project Manager, Clinical Research Associates (CRAs), and the Clinical Operations team to support the delivery of clinical trials in accordance with local regulations, ICH-GCP guidelines, Novotech/client SOPs, and study protocols.

The In-house CRA is responsible for providing operational and administrative support throughout the clinical trial lifecycle, including study start-up activities, essential document management, trial tracking, site communication, and TMF maintenance, helping ensure studies are conducted efficiently and in compliance with applicable requirements.

This role will be based in our Taipei office, with a minimum of 3-4 days per week in the office.

With opportunities to support global studies as the team expands. Therefore, strong written and verbal English communication skills are essential.

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Responsibilities

• Support study start-up activities, including collection and review of essential documents, site activation requirements, and IRB/EC submission documentation.
• Assist CRAs and Project Managers with clinical trial coordination and study tracking activities.
• Maintain and ensure completeness of Trial Master File (TMF/eTMF) documentation throughout the study lifecycle.
• Track site regulatory documents, contracts, and study-related approvals to ensure timely study progress.
• Coordinate communication between study sites, CRAs, Project Managers, and vendors.
• Support site onboarding activities, including investigator and site staff documentation collection.
• Prepare and maintain study trackers, logs, and reports to monitor study status, enrollment, and site activities.
• Support the planning and coordination of investigator meetings, study trainings, and study team meetings.
• Assist with study supplies management and vendor coordination as required.
• Ensure study documentation is maintained in compliance with ICH-GCP, local regulatory requirements and company SOPs.
• Participate in audit and inspection readiness activities and support resolution of documentation-related findings.
• Provide general operational support to Clinical Operations teams across regional and global studies.

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Qualifications & Experience

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related discipline.
• 2-3 years of experience within the clinical research industry, preferably as a CTA, Clinical Trial Coordinator, In-house CRA, or Study Start-Up Specialist.
• Experience supporting clinical studies within a CRO or pharmaceutical company is preferred.
• Familiarity with ICH-GCP guidelines and clinical trial processes.
• Experience with CTMS, eTMF, EDC, and other clinical trial systems is advantageous.
• Strong organizational and document management skills with high attention to detail.
• Ability to manage multiple priorities in a fast-paced matrix environment.
• Effective communication skills in both English and Chinese.
• Proactive, collaborative, and able to work independently with minimal supervision.