🕒 15 days ago
Manage clinical trial activities across global projects, conducting site monitoring and supporting study startup while maintaining site relationships, patient safety, data quality, and compliance with study standards.
Clinical Research Associate II
🔥 19 hours ago
📍 🇨🇦 Canada - Remote🎹 Mid-level🧫 Clinical Research Specialist📢 🇬🇧 English Required📢 🇫🇷 French Required💼 Full-Time
Clinical ResearchOnsite MonitoringClinical Study StartupCRF Review
📜 Description
- Conduct and report onsite monitoring visits.
- Support study startup when applicable and participate in feasibility research.
- Review CRFs, verify source documents, and resolve queries.
- Manage site communications and serve as a contact for in-house support services and vendors.
- Communicate study progress to internal project teams.
- Support the regulatory team with study submission documents.
🛠️ 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
Full job description
Company Description
PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Job Description
As a Clinical Research Associate II at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.
You will:
- 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
- Be responsible for site communication and management
- Be a point of contact for in-house support services and vendors
- Communicate with internal project teams regarding study progress
- Participate in feasibility research
- Support regulatory team in preparing documents for study submissions
Qualifications
- 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
Additional Information
This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.
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