Clinical Research Associate, Oncology (Immunotherapy & Targeted Therapy)

Arbele Limited

Hong Kong

On-site

HKD 480,000 - 720,000

Full time

6 days ago

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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

About the role

Own 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).

Key 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.

About you

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.
Able to travel to sites. Chinese and English are an advantage for China‑US studies.

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