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Senior Clinical Research Associate
2 months ago
Job Overview
As a Senior Clinical Research Associate at PSI, you will play a vital role in ensuring the highest quality standards in clinical studies across various therapeutic indications.
You will:
- Conduct and report on-site monitoring visits, ensuring compliance with regulatory requirements.
- Perform comprehensive CRF review, source document verification, and query resolution to maintain data integrity.
- Manage site communication and relationships, serving as a key point of contact for in-house support services and vendors.
- Collaborate with internal project teams to provide regular study progress updates.
- Participate in feasibility research to identify potential study sites and ensure smooth study execution.
- Support the regulatory team in preparing documents for study submissions, ensuring compliance with regulatory requirements.
- Prepare for and participate in audits and inspections, demonstrating PSI's commitment to quality and compliance.
Requirements
- College/University degree in Life Sciences or an equivalent combination of education, training, and experience.
- Independent on-site monitoring experience, with a strong track record of ensuring compliance and data integrity.
- Experience in all types of monitoring visits in Phase II and/or III, with a focus on Oncology.
- Full working proficiency in English and French is essential, with the ability to communicate effectively with global teams.
- Proficiency in MS Office applications, with the ability to analyze and present data effectively.
- Strong problem-solving skills, with the ability to work in a dynamic team environment and adapt to changing priorities.
- Ability to travel, with a valid driver's license.
About PSI
PSI is a leading provider of clinical research services, dedicated to delivering high-quality results and exceptional customer service. As a Senior Clinical Research Associate, you will be part of a dynamic team that is passionate about advancing medical knowledge and improving patient outcomes.