Oncology CRA — Immunotherapy Trials

Arbele Limited; Hong Kong; On-site; HKD 480,000 - 720,000; Full time

Job summary

Arbele Limited seeks an oncology clinical monitor to oversee monitoring and site management for assigned sites on immunotherapy and targeted-therapy studies in Hong Kong. You will ensure patient safety, data integrity, and TMF readiness under ICH-GCP, protocol, and local requirements.

The role includes site qualification, initiation, routine monitoring, safety follow-up, SDV, and investigator file management, with travel to sites as needed.

Qualifications

• Bachelor’s degree in life sciences, nursing, pharmacy or related field.
• 2–4 years of independent oncology monitoring experience.
• Experience with checkpoint inhibitors, bispecifics, cell therapy or targeted therapies is preferred.

Responsibilities

• Own monitoring and site management for assigned oncology sites on immunotherapy and targeted-therapy studies.
• Protect subject safety and data integrity, ensure TMF readiness under ICH-GCP and local requirements.
• Site qualification, initiation, ongoing monitoring, and close-out; verify site can enroll and manage AEs.
• Safety follow-up for AE/SAE completeness and timely escalation of safety risks.
• Investigator site file and eTMF filing; site relationship management; travel to sites.

Skills

Oncology monitoring

Site management

Safety data integrity

I HC-GCP knowledge

Communication and coordination

Travel to sites

Education

Bachelor’s degree in life sciences, nursing, pharmacy or related field

Tools

EDC/CTMS experience

Job description

Arbele Limited seeks an oncology clinical monitor to oversee monitoring and site management for assigned sites on immunotherapy and targeted-therapy studies in Hong Kong. You will ensure patient safety, data integrity, and TMF readiness under ICH-GCP, protocol, and local requirements.

The role includes site qualification, initiation, routine monitoring, safety follow-up, SDV, and investigator file management, with travel to sites as needed.