• (a)To participate in on-site inspections and related regulatory work for clinical trials conducted in Hong Kong, including review of medical record and trial documents, to ensure compliance with the requirements of the Pharmacy and Poisons Regulations (Cap. 138A) and Good Clinical Practice (GCP) guidelines;
• (b)To evaluate and process applications for clinical trials, through evaluating clinical trial protocols, adverse event reports, and other trial-related documents;
• (c)To handle enquiries from trial sites with respect to findings from GCP inspection and follow-up on the subsequent corrective and preventive actions, and to consolidate inspection findings and draft inspection reports;
• (d)To provide assistance to pharmaceutical product registration, post-marketing surveillance, and other pharmacovigilance activities in relation to clinical perspectives;
• (e)To assist in the formulation and drafting of guidelines and internal procedural documents relating to the regulation of clinical trials and registration of pharmaceutical products; and
• (f)To perform any other duties as assigned by senior officers.

(Remarks: Selected candidates may be required to work shifts outside normal working hours and perform on-call duties.)

Candidates should –

• (a)be permanent residents of the Hong Kong Special Administrative Region;
• (b)possess a medical qualification registrable in Hong Kong under the Medical Registration Ordinance, Cap. 161 or equivalent;
• (c)have a good command of spoken and written Chinese and English; and
• (d)be able to speak fluent Cantonese.