Clinical Research Associate

Vor 3 Tagen


Munich, Bayern, Deutschland Thermo Fisher Scientific Vollzeit
About the Role

Thermo Fisher Scientific is seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will play a critical role in ensuring the success of our clinical trials by providing site management and monitoring services.

Key Responsibilities
  • Perform and coordinate all aspects of clinical monitoring and site management.
  • Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation.
  • 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 to guarantee subjects' rights, well-being and data reliability.
  • Ensure audit readiness.
  • Develop collaborative relationships with investigational sites.
A Day in the Life

As a Clinical Research Associate, you will be responsible for:

  • Monitoring investigator sites with a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
  • Ensuring data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
  • Assessing investigational product through physical inventory and records review.
  • Documenting observations in reports and letters in a timely manner using approved business writing standards.
  • Bringing up observed deficiencies and issues to clinical management expeditiously and following all issues through to resolution.
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).
  • Valid driver's license.
  • Full Right to work in Germany.
  • Fluency in English and German language to at least C1 level.
What We Offer

As a Clinical Research Associate at Thermo Fisher Scientific, you will have the opportunity to work on a wide range of clinical trials, develop your skills and expertise, and contribute to the success of our company.



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