Clinical Research Associate (12-month contract)

About the role

BioLink HK runs early-phase and Phase II studies out of Science Park for sponsors who want an Asia footprint without building one themselves. Our current portfolio is eleven active protocols in oncology, metabolic disease and vaccines, with sites in Hong Kong, Shenzhen and Guangzhou.

This is a twelve-month contract covering a colleague's study leave, attached to a Phase II metabolic protocol that reaches first-patient-in this November. You will carry four sites: two Hong Kong private hospital sites, one university teaching site and one Greater Bay Area partner site, which means roughly two cross-boundary trips a month.

You will report to Nadine Cheung, Head of Clinical Operations for APAC, and work daily with study coordinators, the data management team in Science Park and the sponsor's medical monitor. Contracts here are genuinely a route in — three of our current permanent CRAs joined on cover contracts.

What you'll do

• Conduct site initiation, routine monitoring and close-out visits per the monitoring plan, and file reports within five business days
• Perform source data verification and review informed consent documentation for every enrolled subject
• Track and chase query resolution with sites until the database is clean for interim lock
• Manage investigational product accountability, temperature excursions and shipment reconciliation at site level
• Escalate protocol deviations, safety findings and enrolment risk to the study manager with a proposed mitigation
• Support ethics committee submissions and amendments for Hong Kong sites

What we're looking for

• 3+ years of on-site monitoring experience at a CRO, sponsor or academic trial unit
• Working command of ICH-GCP and Hong Kong ethics committee submission requirements
• Life sciences, nursing or pharmacy degree
• Business-level English and Putonghua; able to run a site visit in either
• Valid travel document permitting regular Hong Kong–Mainland travel, and willingness to travel roughly 40% of the time

Nice to have

• Oncology or metabolic therapeutic-area experience
• Familiarity with Medidata Rave or Veeva Vault CTMS
• Prior work on a study spanning both HK and NMPA regulatory pathways

What you get

• One month completion gratuity on top of salary at contract end
• Medical insurance from day one, including the contract period
• Travel and cross-boundary expenses settled weekly, no month-end backlog
• Hybrid working on non-visit days; core hours only
• First consideration for permanent CRA openings