Clinical Research Associate (at the rank of Technical Officer/Research Assistant I/II)

Clinical Research Associate (at the rank of Technical Officer/Research Assistant I/II) in the Clinical Trials Centre (Ref: 533279)

The Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under The University of Hong Kong LKS Faculty of Medicine (HKUMed) and is dedicated to managing and facilitating international-standard clinical trials on new drugs, medical devices and medical technologies. HKU-CTC offers long-term development opportunities to passionate talents who are devoted to a career in the clinical trial profession.

Clinical studies are highly sophisticated, multi-disciplinary projects that require good planning, close monitoring and synchronization of research team members and activities. HKU-CTC's Project Operations Unit (POU) is a professional unit dedicated to facilitating clinical study planning, performance and completion in compliance with international standards and in an efficient and high-quality manner. POU is seeking talents who are interested/experienced in practising the project management profession in clinical research. Comprehensive on-job training will be provided. Fresh graduates will also be considered.

Main Responsibilities:

• Act as a key contact person among clinical study centres, sponsoring companies, regulatory authorities and other stakeholders to coordinate clinical trial activities
• Facilitate the planning, initiation and monitoring of clinical studies throughout their project life cycles, ensuring adherence to protocols and regulatory requirements
• Assess the feasibility of clinical studies at potential sites to support study planning
• Conduct various visits (including Pre-Study Visits (PSV), Site Initiation Visits (SIV), Site Closure Visits (COV) and Monitoring Visits (MV)) to verify compliance, data integrity, and participant safety
• Support study planning, preparation and initiation (e.g. setting study time plans/milestones, assisting in obtaining ethics and regulatory approvals, importing study products, coordinating logistics and workflows, and organizing study setup)
• Review and verify study data and source documentation for accuracy and completeness
• Monitor the progress and quality of study activities (both on-site at study centres and remotely via electronic data capture systems)
• Oversee study centres compliance with study protocols, Good Clinical Practice (GCP) and other research ethics and regulatory requirements, prepare and write monitoring reports
• Assist in the proper closure of clinical studies
• Facilitate study audits and inspections as needed and
• Perform other duties related to clinical trial management as assigned.

Requirements:

• Bachelor's degree or above in Health, Biological/Life Sciences, Medical, Pharmacy, Nursing or related disciplines
• Experience in clinical research operations and development, and/or basic knowledge in Good Clinical Practice (GCP) are added advantages
• Good interpersonal and communication skills allowing collaboration with cross-functional teams
• Good coordination and problem-solving skills, and commitment to quality and compliance
• Detail-minded, able to handle multiple concurrent tasks, and have a strong sense of responsibility and
• Good command of written and spoken English and Cantonese (proficiency in Putonghua is a plus).

The appointment will commence as soon as possible on a 1-year temporary basis or 2-year fixed-term basis, with the possibility of renewal subject to satisfactory performance. A highly competitive salary commensurate with qualifications and experience will be offered, in addition to annual leave and medical benefits. Appointment on 2-year fixed term basis will attract a contract-end gratuity and University contribution to a retirement benefits scheme, totalling up to 10% of basic salary.

Application Procedure

The University only accepts online application for the above post. Applicants should apply online at the University's careers site () and upload an up-to-date C.V. Review of applications will start from October 9, 2025 and continue until October 25, 2025,or until the post is filled, whichever is earlier.