Note: The job is a remote job and is open to candidates in USA. TRIO - Translational Research in Oncology is a global academic clinical research organization focused on advancing cancer research. They are seeking a Clinical Research Associate to join their Monitoring Resource team, responsible for conducting site visits, ensuring compliance with regulations, and mentoring junior team members.
Responsibilities
- Performing data verification of source documents
- Conducting site visits, including pre-study, initiation, monitoring, and termination
- Confirming adherence to all FDA, ICH-GCP, and local regulations
- Ensuring implementation and 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 required
- Ensuring the completion and collection of regulatory documents
Skills
- A minimum of 2 years of monitoring experience in oncology trials
- Experience monitoring in early-phase trials will be valued
- 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
- Must be legally authorized to work in the country
Company Overview
TRIO is an academic clinical research organization that is dedicated to advancing translational cancer research. It was founded in 1997, and is headquartered in Edmonton, Alberta, CAN, with a workforce of 201-500 employees. Its website is http://www.trioncology.org.