Monitor clinical studies onsite, conduct SIV/RMV/COV visits, perform CRF review and SDV, manage site communications, support regulatory submissions, participate in feasibility, and prepare for audits and inspections.
Company Description
PSI is a leading Contract Research Organization with 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 DescriptionAs a Clinical Research Associate 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 SIV, RMV, COV onsite monitoring visits
- 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
- Prepare and particiapte on audits and inspections
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- Independent on-site monitoring experience
- Experience in all types of monitoring visits in Phase II and/or III
- Experience in Oncology is a plus
- Full working proficiency in English and French is essential.
- 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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