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 translational cancer research in clinical trials. The Clinical Research Associate or Senior Clinical Research Associate supports oncology trials through site monitoring, data verification, regulatory compliance, and collection of regulatory documents.
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
- 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 3 years of oncology experience as a CRA, Clinical Research Coordinator, and/or Research Nurse
- Minimum of 1 year monitoring experience on an early phase trial
- 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
- Must be legally authorized to work in the United States
- Experience monitoring Phase I trials
- Experience in solid tumor trials, including breast, lung, gastric, ovarian, and/or pancreatic cancer, is preferred
Benefits
- Remote work
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