Conduct onsite monitoring across clinical studies, oversee site communication and study progress, review clinical data, resolve queries, and support study startup and regulatory submissions.
Clinical Research Associate II
π Description
- Conduct and report onsite monitoring visits across clinical studies.
- 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 support services and vendors.
- Communicate study progress to internal project teams.
- Support the regulatory team with study submission documents.
π οΈ 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 driverβs 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.Β 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
Β
- 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 driverβs license
Β
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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