Bucharest, Bucharest, Romania
3 days ago
Senior Clinical Research Associate

Company Description

PSI is a leading Contract Research Organization with more than 29 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 Senior 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, SSV, RMV, COV onsite monitoring visitsPerform CRF review, source document verification and query resolutionBe responsible for site communication and managementBe a point of contact for in-house support services and vendorsCommunicate with internal project teams regarding study progressParticipate in feasibility researchSupport regulatory team in preparing documents for study submissionsPrepare and participate on audits and inspections

QualificationsCollege/University degree in Life Sciences or an equivalent combination of education, training & experienceIndependent on-site monitoring experienceExperience in all types of monitoring visits in Phase II and/or III studiesExperience in Oncology, Infectious Diseases and IBD is a plusFull working proficiency in Romanian and EnglishProficiency in MS Office applicationsValid driver’s license & ability to travel

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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