Inhouse CRA

About the role

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.

Key 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.

About you

• 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.