Clinical Research Associate
vor 16 Stunden
If you are an experienced CRA who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is the place for you
- TRIO (Translational Research in Oncology) is an academic clinical research organization that is dedicated to advancing translational cancer research by pursuing forward innovative and targeted therapeutic concepts in the clinical trial setting. We are committed to providing treatments of the future to the world of today._
**We are looking for Clinical Research Associates** to join our international team, **home-based in Germany**. Our CRAs play a pivotal role in moving our important research forward and helping to save cancer patients’ lives all over the world.
TRIO’s head office is in Edmonton, Alberta with operations throughout Canada, the USA, France and Uruguay. The main objective of the Monitoring Resources team is to effectively monitor TRIO’s clinical trials according to contractual obligations and project deadlines according to the sponsor protocol and in compliance with the appropriate SOPs.
Reporting to a Monitoring Resources Coordinator, a CRA is responsible for the following:
- Conducting site visits, including pre-study, initiation, monitoring and termination;
- Confirming adherence to all FDA, ICH-GCP and local regulations;
- Ensuring the completion and collection of regulatory documents;
- Performing data verification of source documents;
- Ensuring implementation and compliance with FDA, ICH-GCP guidelines;
- Participating in budget negotiation and follow-up where applicable;
- Assisting with data validation and query resolution;
- Mentoring junior team members as required.
**Qualifications**:
- A minimum of 2 years of monitoring experience in oncology trials
- An advanced level of oncology knowledge
- Completion of a science-related Bachelor’s degree
- Excellent knowledge of medical terminology and clinical monitoring process
- Strong ICH-GCPs knowledge
- Experience with clinical trial information systems
- Ability to travel up to 60% on average
**Integrity - Teamwork - Passion**
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