Clinical Research Associate

vor 4 Wochen


Munich, Bayern, Deutschland Thermo Fisher Scientific Vollzeit

At Thermo Fisher Scientific, we're committed to advancing healthcare through innovative solutions. As a Clinical Research Associate, you'll play a critical role in ensuring the success of our clinical trials. Your expertise in site management and quality assurance will be instrumental in delivering high-quality results and driving business growth.

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.
  • Act as a site processes specialist, ensuring trials are conducted in accordance with approved protocols, ICH-GCP guidelines, and applicable regulations.
  • Ensure audit readiness and develop collaborative relationships with investigational sites.
  • Perform detailed tasks and responsibilities as outlined in the task matrix.

A Day in the Life:

  • Monitor investigator sites with a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving skills to identify site processes failures and corrective/preventive actions.
  • Ensure data accuracy through SDR, SDV, and CRF review as applicable through on-site and remote monitoring activities.
  • Assess investigational product through physical inventory and records review.
  • Document observations in reports and letters in a timely manner using approved business writing standards.
  • Bring up observed deficiencies and issues to clinical management expeditiously and follow 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 providing 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:

  • A dynamic and supportive work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.
  • The chance to work on challenging and rewarding projects.


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