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-CTCs 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:
- Bachelors 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 Universitys careers site () and upload an up-to-date C.V. Review of applications will start from October 9 2025 and continue until October 25 2025or until the post is filled whichever is earlier.
Required Experience:
IC
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 i...
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-CTCs 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:
- Bachelors 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 Universitys careers site () and upload an up-to-date C.V. Review of applications will start from October 9 2025 and continue until October 25 2025or until the post is filled whichever is earlier.
Required Experience:
IC
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