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Experience Level
Experience
Qualifications
The ideal candidate will possess:A College or University degree in Life Sciences or equivalent education, training, and experience. Demonstrated experience in independent on-site monitoring. Familiarity with all types of monitoring visits in Phase II and/or III studies. Experience in Oncology is an advantage. Proficiency in both English and French is essential. Strong skills in MS Office applications. Excellent planning, multitasking, and teamwork abilities in a dynamic environment. Outstanding communication, collaboration, and problem-solving skills. Willingness to travel as required. A valid driver’s license.
About the job
Join PSI as a Senior Clinical Research Associate (CRA) and immerse yourself in a dynamic role where you will execute a variety of monitoring tasks across diverse clinical studies. With a commitment to maintaining the highest quality standards in the industry, you will play a crucial part in advancing medical research.
Your responsibilities will include:
Conducting and reporting Site Initiation Visits (SIV), Routine Monitoring Visits (RMV), and Closeout Visits (COV) on-site.
Performing Case Report Form (CRF) reviews, source document verification, and query resolution.
Managing site communications and fostering strong relationships with study sites.
Serving as a key point of contact for in-house support services and vendors.
Collaborating with internal project teams to provide updates on study progress.
Engaging in feasibility research to assess potential study sites.
Assisting the regulatory team in preparing documentation for study submissions.
Preparing for and participating in audits and inspections to ensure compliance and quality assurance.
About PSI
PSI is a premier Contract Research Organization with over 30 years of expertise in the industry. We offer an exceptional blend of stability and innovation, ensuring high-quality and timely services across a range of therapeutic indications.
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