Clinical Research Associate, Oncology (Immunotherapy & Targeted Therapy)

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

Job summary

Arbele is seeking a Clinical Research Associate, Oncology (Immunotherapy & Targeted Therapy) to manage monitoring and site relationships for selected oncology sites in Hong Kong. This on-site role emphasizes patient safety, data integrity, and TMF readiness in alignment with ICH-GCP and local regulations.

Responsibilities include site qualification, initiation, SRV, safety reporting, and drug accountability, with strong emphasis on AE/SAE handling, protocol compliance, and collaboration with

Qualifications

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field.
• 2–4 years of independent oncology monitoring experience preferred.
• Hands-on monitoring of immunotherapy or targeted therapies beneficial.
• Knowledge of immune-related adverse-event management and targeted-therapy toxicities.
• ICH-GCP, local regulatory monitoring and EDC/eTMF/CTMS experience.
• Strong communication and stakeholder management skills.

Responsibilities

• Site qualification, initiation, interim monitoring, and close-out.
• Review informed consent, verify eligibility, and identify protocol deviations with timely safety escalation.
• Source data verification and review against EDC with focus on dosing, premedication, SAEs, and concomitant meds.
• Safety follow-up at site level: AE/SAE completeness and reporting timelines; escalate immune-related events the same day.
• Investigational product accountability with site pharmacy: receipt, storage, temperature excursions, preparation, administration, destruction, reconciliation.
• Query resolution, missing-page chase, and lab/imaging/biomarker sample tracking.
• Investigator site file and eTMF filing against the expected documentation; monitoring visit reports within company timeline.
• Site relationship management with PI, study coordinator, pharmacy, and local lab; support enrollment against approved population.
• Close-out: final drug reconciliation, query closure, ISF completeness, and archive instructions.

Skills

Oncology monitoring

Site management

Safety reporting

Communication

Coordination

Stakeholder management

Education

Bachelor’s degree in life sciences

Tools

ICH-GCP

EDC

eTMF

CTMS

Job description

Company Description

Arbele is a biotechnology company specializing in targeted immunotherapy for cancers and autoimmune diseases. The team brings over 30 years of experience in multinational pharmaceutical research, development, and business operations. Arbele’s mission is to deliver innovative, cost-effective therapeutics for diseases with significant unmet medical needs. The company focuses on advanced antibody-based platforms, including T-cell engagers (TCE), antibody-drug conjugates (ADC), and mRNA-based gene and cell therapies. Its culture emphasizes rigorous science, strong business integrity, and committed social values.

Role Description

This full-time Clinical Research Associate, Oncology (Immunotherapy & Targeted Therapy) role is an on-site position based in Hong Kong. The position is responsible for o wn monitoring and site management for assigned oncology sites on immunotherapy and targeted-therapy studies. Protect subject safety and data integrity, and keep the site file and sponsor TMF inspection-ready under ICH-GCP, the protocol, and local requirements (NMPA, FDA, TGA as applicable).

Responsibilities:

• Site qualification, initiation, interim monitoring, and close-out. Confirm the site can enroll, administer, and manage immune-related adverse events and targeted-therapy toxicities before activation.
• Informed consent review, eligibility source-data verification, and protocol-deviation identification, with timely escalation of safety and enrollment risks.
• Source data verification and source data review against EDC, with focus on dosing or administration, premedication, adverse events, serious adverse events, dose modifications, and concomitant medication.
• Safety follow-up at site level: AE/SAE completeness, reporting timelines, and consistency with the medical monitor. Escalate suspected immune-related adverse events (colitis, pneumonitis, hepatitis, endocrinopathies, rash) and class-specific targeted-therapy toxicities the same day.
• Investigational product accountability with the site pharmacy: receipt, storage, temperature excursions, preparation, administration, destruction, and reconciliation. Follow the pharmacy manual for each agent.
• Query resolution, missing-page chase, and lab/imaging/biomarker sample tracking, including companion-diagnostic samples where the protocol requires them.
• Investigator site file and eTMF filing against the expected-document list. Monitoring visit reports within the company timeline.
• Site relationship management: principal investigator, study coordinator, pharmacy, and local lab. Support enrollment against the approved population, not off-protocol patients.
• Close-out: final drug reconciliation, query closure, ISF completeness, and archive instruction.

Qualifications

• Bachelor’s degree in life sciences, nursing, pharmacy, or a related field.
• At least two to four years of independent oncology monitoring. Phase 1 or 1b solid-tumor or hematology experience is strongly preferred.
• Hands-on monitoring of checkpoint-inhibitor, bispecific, cell-therapy, or other immunotherapy studies, or of small-molecule or antibody targeted therapies. Both is ideal; one is acceptable if the other can be trained.
• Working knowledge of immune-related adverse-event management and of common targeted-therapy toxicities (hypertension, hand-foot syndrome, QT prolongation, myelosuppression, depending on the class).
• ICH-GCP, local regulatory monitoring practice, and EDC/eTMF/CTMS experience.
• Strong communication, coordination, stakeholder management, and resource integration skills.