About The Position
As a Clinical Research Associate II at PSI, you will perform a variety of monitoring tasks on clinical studies across different therapeutic indications while maintaining high quality standards. The role involves conducting and reporting monitoring visits, supporting study startup when applicable, reviewing case report forms, verifying source documents, resolving queries, and managing site communications. You will also coordinate with in-house support services, vendors, and internal project teams, participate in feasibility research, and support the regulatory team with study-submission documents.
Requirements
- College or university degree in Life Sciences, or an equivalent combination of education, training, and experience.
- Independent on-site monitoring experience in North America.
- Experience with all types of monitoring visits in Phase II and/or III studies.
- 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.
Responsibilities
- Conduct and report all types of onsite monitoring visits.
- Participate in study startup when applicable.
- Perform CRF review, source document verification, and query resolution.
- Manage site communications and site management.
- Act as a point of contact for in-house support services and vendors.
- Communicate study progress to internal project teams.
- Participate in feasibility research.
- Support the regulatory team in preparing documents for study submissions.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
