Clinical Research Associate II, Oncology
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Job Description
Clinical Research Associate II monitoring oncology clinical trials for IQVIA Biotech, a global clinical research services CRO. Managing sites from start-up through close-out.
Responsibilities:
- Monitor Phase I–IV clinical trials for compliance with protocols, GCP/ICH guidelines, and regulatory requirements
- Manage site activities from start-up through close-out
- Conduct site selection, initiation, monitoring, and close-out visits
- Train site personnel on study protocols, EDC systems, and study requirements
- Ensure high-quality source documentation and data integrity
- Resolve queries in a timely manner
- Oversee investigational product accountability and regulatory document collection
- Serve as the primary site contact and maintain regular communication
- Prepare monitoring reports according to SOPs and timelines
- Support investigator meetings and collaborate with CTMs/Lead CRAs
Requirements:
- Bilingual in French and English (required)
- Bachelor's degree required, preferably in life sciences or a related discipline
- An equivalent combination of education, training, and experience may be accepted in lieu of a degree
- At least 1 year of on-site monitoring experience required
- Ability to travel 65–70%
- Knowledge of clinical trial protocols, GCP/ICH guidelines, and regulatory requirements
- Experience with oncology monitoring
- Experience with EDC systems
Benefits:
- Incentive plans, bonuses, and/or other forms of compensation may be offered
- Health and wellness benefits
- Other benefits
- Equal opportunity employer
- Accommodations for applicants with disabilities throughout the recruitment process
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