Clinical Research Associate

1 giorno fa

Roma, Italia Translational Research in Oncology A tempo pieno

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

Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today.

TRIO is looking for a Clinical Research Associate** **to join our Monitoring Resources team. Reporting to the Monitoring Resources Coordinator, this position will be home-based in Italy.

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.

**Responsibilities**:

- 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

**What TRIO Can Offer You**:

- Competitive salary
- Paid time off
- Flexible working hours

**Integrity - Teamwork - Passion**

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