Clinical Research Associate monitoring clinical trials for ICON, a global healthcare intelligence and clinical research organization. Ensuring protocol, ICH - GCP, and regulatory compliance across investigative sites and remote studies.
About the role
- Clinical Research Associate II conducting onsite monitoring and regulatory support for PSI, a contract research organization. Managing sites, CRF review, queries, and study progress across clinical trials.
Responsibilities
- Conduct and report all types of onsite monitoring visits
- Be involved in study startup, if applicable
- Perform CRF review, source document verification and query resolution
- Manage site communication and management
- Serve as a point of contact for in-house support services and vendors
- Communicate with internal project teams regarding study progress
- Participate in feasibility research
- Support the regulatory team in preparing documents for study submissions
Requirements
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- Independent on-site monitoring experience in North America
- Experience in all types of monitoring visits in Phase II and/or III
- Full working proficiency in English and French
- Proficiency in MS Office applications
- Ability to plan, multitask and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
- Ability to travel
- Valid driver’s license
Benefits
- Remote work permitted
- Opportunity to further develop skills
- Opportunity to widen therapeutic area experience
- Opportunity to become an expert in clinical research
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