Translational Research in Oncology (TRIO) sucht einen Clinical Research Associate (CRA) für den Standort Deutschland. In dieser Rolle sind Sie für die Durchführung von Site Visits, die Überwachung von klinischen Studien gemäß ICH-GCP-Richtlinien und die Datenverifizierung verantwortlich. TRIO ist eine akademische Forschungsorganisation, die sich der Förderung der translationalen Krebsforschung widmet. Wenn Sie über mindestens 2 Jahre Erfahrung im Monitoring von Onkologie-Studien verfügen und sich für die Krebsforschung begeistern, ist dies eine großartige Gelegenheit. Das Team ist international und bietet die Möglichkeit, einen wichtigen Beitrag zur Lebensrettung von Krebspatienten zu leisten.
Are you an experienced CRA with a passion for oncology research? Join the highly skilled team at TRIO!
TRIO (Translational Research in Oncology) is dedicated to advancing translational cancer research through innovative and targeted therapeutic concepts in clinical trials. We're committed to bringing the treatments of tomorrow to the world today.
TRIO is seeking Clinical Research Associates to join our international team,home-based in Germany. As a CRA, you'll play a crucial role in advancing our research and helping to save cancer patients' lives globally.
TRIO's head office is in Edmonton, Alberta, with operations across Canada, the USA, France, and Uruguay. The Monitoring Resources team ensures effective monitoring of TRIO's clinical trials, adhering to contractual obligations, project deadlines, sponsor protocols, and SOPs.
Reporting to a Monitoring Resources Coordinator, your responsibilities will include:
- Conducting site visits (pre-study, initiation, monitoring, and termination)
- Ensuring adherence to FDA, ICH-GCP, and local regulations
- Completing and collecting regulatory documents
- Performing data verification of source documents
- Ensuring compliance with FDA and ICH-GCP guidelines
- Participating in budget negotiation and follow-up (where applicable)
- Assisting with data validation and query resolution
- Mentoring junior team members as needed
Qualifications:
- Minimum of 2 years of monitoring experience in oncology trials
- Advanced knowledge of oncology
- Science-related Bachelor’s degree
- Excellent understanding of medical terminology and clinical monitoring processes
- Strong ICH-GCP knowledge
- Experience with clinical trial information systems
- Ability to travel up to 60%
Innovation • Teamwork • Passion • Integrity
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