Clinical Research Associate

1 month ago

Hong Kong, Central and Western District, Hong Kong SAR China Thermo Fisher Scientific Full time
Job Summary

We are seeking a highly skilled Clinical Research Associate (CRA) - Level II to join our team at Thermo Fisher Scientific. As a CRA, you will be responsible for conducting clinical monitoring and site management activities to ensure the integrity and quality of clinical trials.

Key Responsibilities
  • Conduct remote or on-site visits to assess protocol and regulatory compliance, and manage required documentation.
  • Manage procedures and guidelines from different sponsors and/or supervising environments.
  • Act as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.
  • Develop collaborative relationships with investigational sites.
  • Monitor investigator sites with a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving skills to identify site processes failure and corrective/preventive actions.
  • Ensure data accuracy through SDR, SDV, and CRF review as applicable through on-site and remote monitoring activities.
  • Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
  • Participate in investigator meetings, identify potential investigators, and ensure the acceptability of qualified investigative sites.
  • Contribute to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
Requirements
  • Bachelor's degree in a life sciences-related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).
  • Effective clinical monitoring skills, demonstrated understanding of medical/therapeutic area knowledge and medical terminology, and excellent understanding and demonstrated application of ICH GCPs, applicable regulations, and procedural documents.
  • Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem-solving.
  • Ability to manage Risk-Based Monitoring concepts and processes, effective oral and written communication skills, and ability to maintain customer focus through the utilization of good listening skills, attention to detail, and the ability to perceive customers' underlying issues.
What We Offer

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.

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