Inhouse CRA

诺维泰医药科技(上海)有限公司; Hong Kong Island; Sur place; HKD 300 000 - 520 000; Plein temps

Résumé du poste

Novotech is seeking an In-house Clinical Research Associate to collaborate with the Project Manager, CRAs and Clinical Operations. You will support trial start-up, essential document management, TMF maintenance and site communications throughout the study lifecycle.

The role requires a Life Sciences/Clinical background with 2–3 years of CRO/pharma experience and familiarity with CTMS, eTMF and EDC systems. English and Chinese communication skills are essential.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Medicine, or related field.
• 2–3 years of experience in clinical research, preferably as CTA/Coordinator/In-house CRA/Start-Up Specialist.
• Experience with ICH-GCP guidelines and clinical trial processes.
• Familiarity with CTMS, eTMF, EDC and other trial systems.

Responsabilités

• Support study start-up activities, including collection and review of essential documents and IRB/EC submission documentation.
• Coordinate with CRAs, Project Managers, and vendors to ensure trial progress.
• Maintain and ensure completeness of TMF/eTMF documentation.
• Track site regulatory documents, contracts, and approvals to ensure timely progress.
• Coordinate communication between study sites, CRAs, Project Managers, and vendors.
• Support site onboarding and investigator/staff documentation collection.
• Prepare study trackers, logs and reports to monitor status and enrollment.
• Assist with investigator meetings, trainings and study team meetings.
• Ensure study documentation complies with ICH-GCP and SOPs.

Connaissances

Organizational skills

Documentation management

Multitasking

English & Chinese communication

Formation

Bachelor's degree in Life Sciences/Pharmacy/Nursing/Medicine

Outils

CTMS

eTMF

EDC

Description du poste

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.