Clinical Research Associate/ Senior CRA - Czech

Work Schedule

Environmental Conditions

Job Description

Thermo Fisher Scientific: Join Us for a Global Impact

At Thermo Fisher Scientific, we offer meaningful careers that make a global difference. Join us in fulfilling our mission: empowering customers to enhance the world's health, cleanliness, and safety. We provide the resources needed to help our employees achieve their career aspirations and advance science through the research, development, and delivery of life-changing therapies. Our work encompasses laboratory, digital, and decentralized clinical trial services across over 100 countries. Your dedication to quality and accuracy will drive better health outcomes for people and communities worldwide.

Clinical Department Overview

Our clinical department is responsible for defining, developing, and delivering clinical programs. Our global Clinical Operations team, part of our PPD clinical research services, offers comprehensive support for clinical trials, from study initiation to monitoring and study close-out, across both commercial and government contracts. Together, we assist clients in defining and developing clinical programs, reducing delays, and implementing high-quality, cost-effective clinical studies.

Discover Impactful Work

• Oversee and coordinate all aspects of the clinical monitoring and site management process.
• Conduct remote or on-site visits to assess protocol and regulatory compliance and manage necessary documentation.
• Navigate and manage procedures and guidelines from various sponsors and monitoring environments.
• As a site processes specialist, ensure trials adhere to approved protocols, ICH-GCP guidelines, regulations, and SOPs, safeguarding the rights, well-being, and data reliability of subjects.
• Ensure audit readiness.
• Develop collaborative relationships with investigational sites.

A Day in the Life

• Monitor and analyze investigator sites to identify process failures, taking corrective/preventive actions to ensure compliance and mitigate risks.
• Ensure data accuracy through SDR, SDV, and CRF review, applicable through on-site and remote monitoring activities.
• Record observations in reports and letters promptly, adhering to approved business writing standards.
• Expedite the communication of observed deficiencies and issues to clinical management and follow through to resolution.
• Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
• Ensure all essential documents are complete and compliant with ICH-GCP and applicable regulations, conducting on-site file reviews per project specifications.
• Respond to company, client, and regulatory requirements/audits/inspections as necessary.

Education and Experience

• Bachelor's degree in a life sciences-related field or equivalent experience, or a Registered Nursing certification, with relevant formal academic/vocational qualifications.
• Demonstrated understanding of ICH-GCP, EU, and FDA requirements.
• Experience with independent, on-site monitoring in a Pharmaceutical or Clinical Research Organization.

Knowledge, Skills, Abilities

• Proficiency in medical/therapeutic area knowledge and medical terminology.
• Well-developed critical thinking skills and strong attention to detail.
• Effective organizational and time management skills.
• Ability to work both independently and as part of a team.
• Proficiency in German (C1 level) and English.

Employee Wellbeing

Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.

We offer a competitive salary and benefits package, along with a flexible working culture where work-life balance is genuinely valued.