Senior Clinical Research Associate

Company DescriptionWe are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals. We work on the front-line of medical science, changing lives, and bringing new medicines to those who need them.If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.Job DescriptionAs a Senior Clinical Research Associate you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. You will focus on subjects’ rights, safety and well-being and quality of data compliance.You will:Conduct and report all types of onsite monitoring visitsBe involved in study startup (if applicable)Perform CRF review, source document verification and query resolutionBe responsible for site communication and managementSupervise study activities, timelines, and schedules on the country levelBe a point of contact for in-house support services and vendorsBe involved in quality control, such as compliance monitoring and reports reviewParticipate in feasibility researchSupport regulatory team in preparing documents for study submissionsQualificationsCollege/University degree in Life Sciences or an equivalent combination of education, training & experienceIndependent on-site monitoring experience in the USA (5 years minimum)Experience in all types of monitoring visits in Phase I-IIIParticipation in clinical projects as a Senior MonitorExperience monitoring complex Oncology trials required; experience with radiopharmaceuticals and/or breast cancer preferredExperience monitoring GI studies (IBD, Chron’s, UC) is preferred. Full working proficiency in EnglishProficiency in MS Office applicationsAbility to plan, multitask and work in a dynamic team environmentCommunication, collaboration, and problem-solving skillsAbility to travel up to 80%Valid driver’s license (if applicable)Additional InformationAdvance your career in clinical research and lead challenging full-service projects on the country/regional level while growing with a rapid company, that puts its people first! You will get hands-on involvement in every aspect of the study.For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

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