Senior Clinical Research Associate
Corporation
Laichikok, Kowloon
1天前

Senior Clinical Research Associate

Company : Corporation / Salary : $Negotiable

Responsibilities

  • Assist director of the region in project management of clinical trial studies;
  • Verify that the rights and well -being of subjects are protected, the reported trial data are accurate, complete, and verifiable from source documents, and the conduct of the trial is in compliance with the currently approved protocol / amendment(s), GCP, and applicable regulatory requirement(s);
  • Ensure site compliance while conducting qualification, study initiation, routine monitoring, and study site close-out visits for research sites according to relevant Standard Operating Procedures (SOPs);
  • Serve as the primary resource to the clinical investigator and site staff;
  • Maintain close collaboration, interaction, and effective working relationships with other employees;
  • Ensure quality completion of visit reports, follow-up letters, and maintenance of study-related databases and monitoring portal;
  • Represent responsibility of CRA at Sponsor (both established and new clients) meetings;
  • Assist in design, development, and evaluation of SOPs
  • Minimum requirement

  • University graduate, preferably with Master’s degree, in sciences or health care discipline. A BSN qualification is definite an advantage;
  • At least 5 years monitoring experience gained from CRO or pharmaceutical industries, preferably regional lead experience in clinical project management, particularly in north & south east Asia;
  • Demonstrate strong knowledge in ICH / GCP guidelines, drug therapy techniques, clinical research methodologies, etc.;
  • Detail-minded, well-organized and self-motivated;
  • Strong communication skills in verbal and written English;
  • Excellent analytical and problem-solving skill;
  • Able to work well both in teams or independently without close supervision
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