Clinical Research Associate
5 giorni fa
Napoli, Italia
Translational Research in Oncology
Tempo pieno
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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 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 Associateto join our Monitoring Resources team. Reporting to a CRA Line Manager,*
* this position will be home-based in Italy. 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
- Experience in monitoring early-phase trials
- Fluent in English
- 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 annual leave
- Health insurance plan
- Flexible
working hours
- Luggage allowance
- Mobile phone allowance Salary to be influenced (or determined) by the education, experience, location, knowledge, skills, abilities of the applicant, internal equity, and alignment with market data. Teamwork
- Passion
- Integrity
- Innovation Teamwork
- Passion
- Integrity
- Innovation cczUsif7ft
* this position will be home-based in Italy. 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
- Experience in monitoring early-phase trials
- Fluent in English
- 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 annual leave
- Health insurance plan
- Flexible
working hours
- Luggage allowance
- Mobile phone allowance Salary to be influenced (or determined) by the education, experience, location, knowledge, skills, abilities of the applicant, internal equity, and alignment with market data. Teamwork
- Passion
- Integrity
- Innovation Teamwork
- Passion
- Integrity
- Innovation cczUsif7ft