Clinical Quality Assurance Specialist
6 dagen geleden
Quality Management Specialist (Technical Officer/Research Assistant I/II) at the Clinical Trials Centre
The Clinical Trials Centre (HKU-CTC) operates as a premier platform for managing clinical trials, established under the LKS Faculty of Medicine (HKUMed). Our mission is to facilitate international-standard clinical trials involving innovative drugs, medical devices, and advanced medical technologies. We are committed to fostering long-term career development for individuals who are passionate about advancing their careers in this field.
Ensuring quality and compliance is essential for the success of clinical research initiatives. The Quality Management Team (QMAT) at HKU-CTC is a dedicated group focused on upholding research integrity and compliance through the development and execution of comprehensive quality assurance (QA) and quality control (QC) strategies. We are looking for individuals who are keen to engage in the quality management profession within the clinical research sector.
Key Responsibilities
- Oversee quality management processes for HKU-CTC and associated clinical study activities;
- Sustain an effective QA framework;
- Create and uphold standard operating procedures;
- Support participation in quality assurance and accreditation initiatives;
- Conduct internal QC assessments and coordinate external audits/inspections.
Qualifications
- A Bachelor's degree or higher in Biological, Medical, Life Sciences, Quality Management, or related fields;
- At least 2 years of experience in clinical research quality management, monitoring, or project management/operations;
- Comprehensive understanding of Good Clinical Practice (GCP) and relevant local/national/international regulations and guidelines in clinical research;
- Excellent coordination and problem-solving abilities, strong interpersonal and communication skills, and a commitment to quality and compliance;
- Detail-oriented, capable of managing multiple tasks simultaneously, self-driven, and possessing a strong sense of responsibility;
- Proficient in written and spoken English and Chinese is essential;
- Proficiency in Putonghua is advantageous.
The position is offered on a two-year fixed-term full-time contract basis, with the possibility of renewal based on performance. A competitive salary aligned with qualifications and experience will be provided, along with a contract-end gratuity and a University contribution to a retirement benefits scheme at 10% of the basic salary. Additional benefits include annual leave and medical coverage.
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