Clinical Research Associate

1 month ago

Guangzhou, Guangdong, China Thermo Fisher Scientific Full time
Job Summary

We are seeking a highly skilled Clinical Research Associate to join our team at Thermo Fisher Scientific. As a key member of our clinical operations team, you will be responsible for conducting clinical monitoring and site management activities to ensure the successful execution of clinical trials.

Key Responsibilities
  • Conduct risk-based monitoring activities to identify site processes failures and implement corrective actions to bring sites into compliance.
  • Ensure data accuracy through source document review, site visits, and CRF review.
  • Assess investigational product through physical inventory and records review.
  • Document observations in reports and letters in a timely manner using approved business writing standards.
  • Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
  • Provide trial status tracking and progress update reports to the Clinical Team Manager as required.
  • Participate in investigator meetings and identify potential investigators to ensure the acceptability of qualified investigative sites.
  • Ensure that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations.
  • Conduct on-site file reviews as per project specifications.
Requirements
  • Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent.
  • Previous experience as a clinical research monitor or equivalent.
  • Effective clinical monitoring skills, including critical thinking and problem-solving skills.
  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
  • 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, with the ability to communicate effectively with medical personnel.
  • Ability to maintain customer focus through the utilization of good listening skills, attention to detail, and the ability to perceive customers' underlying issues.
  • Effective interpersonal skills.
  • Strong attention to detail.
  • Effective organizational and time management skills.
  • Ability to remain flexible and adaptable in a wide range of scenarios.
  • Ability to work in a team or independently as required.
  • Good digital literacy: proficient knowledge of Microsoft Office and the ability to learn appropriate software.
  • Good English language and grammar skills.
  • Good presentation skills.
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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