Clinical Research Associate

4 tygodni temu

Poland MyGwork Pełny etat
Job Description

This role is with Thermo Fisher Scientific, an inclusive employer and a member of MyGwork – the largest global platform for the LGBTQ+ business community.

Please do not contact the recruiter directly.

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description

Main Responsibilities:

  1. Ensure Protocol Compliance: Conduct remote or on-site visits to assess protocol and regulatory compliance and handle required documentation.
  2. Manage Site Processes: Act as a site processes specialist, ensuring that the trial is conducted according to the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability.
  3. Monitor Investigator Sites: Monitor investigator sites with a risk-based monitoring approach: applies 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.
  4. Ensure Data Accuracy: Ensure data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
  5. Assess Investigational Product: Assess investigational product through physical inventory and records review.

Requirements:

  • Bachelor's degree in a life sciences field.
  • At least 9 to 18 months of experience of independent, on-site monitoring in a Pharmaceutical or Clinical Research Organisation.
  • Experience in clinical trials, medical terminology, medical research, clinical research, health care or in a health sciences field.
  • Valid driver's license where applicable.
  • Oncology or Haemato-oncology experience highly preferable.

Why Join Us?

At Thermo Fisher Scientific, we're committed to making the world a healthier, cleaner, and safer place. We're a global organization with a local feel, and we're dedicated to providing our employees with the resources and opportunities they need to grow and succeed. If you're passionate about making a difference, join us today.

Our Mission: To enable our customers to make the world healthier, cleaner and safer.

Our Values: Integrity, Intensity, Innovation and Involvement.

Equal Employment Opportunity: Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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