[Remote] Clinical Research Associate-Freelance
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
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