Clinical Research Associate Specialist

4 weken geleden

Utrecht, Utrecht, Nederland HKU Voltijd

HKU Clinical Trials Centre: A Career in Clinical Research



The HKU-CTC is a leading clinical trials management platform, established under the LKS Faculty of Medicine. We are dedicated to managing and facilitating international-standard clinical trials on new drugs, medical devices, and medical technologies.



We offer long-term development opportunities to passionate talents who are devoted to a career in the clinical trial profession. Our Project Operations Unit (POU) is a professional unit that facilitates clinical study planning, performance, and completion in compliance with international standards and in an efficient and high-quality manner.



PDOU is undergoing rapid development and is seeking a highly calibre talent to join our POU as a Clinical Research Associate (CRA).



Main Responsibilities:


  • Act as a key contact person among clinical study centres, sponsoring companies, regulatory authorities, and other stakeholders;
  • Facilitate the planning, initiation, and monitoring of clinical studies throughout their project life cycles;
  • Assess the feasibility of clinical studies;
  • Support study planning, preparation, and initiation (e.g. setting study time plans/milestones, obtaining ethics and regulatory approvals, importing study products, communicating on central laboratory and logistic arrangements, and organizing study initiation meetings);
  • Monitor the progress and quality of study activities (both on-site at study centres and off-site via online electronic systems);
  • Oversee study centres' compliance with study protocols, Good Clinical Practice (GCP), and other research ethics and regulatory requirements, and writing monitoring reports;
  • Assist in the proper closure of clinical studies;
  • Facilitate study audits and inspections as needed.


Requirements:


  • Bachelor's degree or above in Health, Biological/Life Sciences, Medical, Pharmacy, Nursing, or related disciplines;
  • Experience in clinical research operations and development;
  • 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;
  • Good command of written and spoken English and Cantonese (proficiency in Putonghua is a plus).


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

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