Clinical Research Associate / Senior CRAFull-timeCompany DescriptionPSI 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 be collaborating with experienced clinical research professionals who are committed to quality, teamwork, and advancing clinical research.Remote role in UkraineYour responsibilities will include:Preparing, conducting, and reporting on all types of monitoring visits, including site selection, initiation, routine monitoring, and close-out visitsEnsuring compliance with study protocols, ICH-GCP guidelines, and regulatory requirementsBuilding and maintaining strong relationships with investigators and site staffMonitoring patient recruitment, study timelines, and site performancePerforming source data verification, following up on data queries, and managing site-level risksOverseeing investigational product accountability, trial supplies, and essential study documentationMaintaining Investigator Site Files (ISF) and supporting Trial Master File (TMF) reconciliationDelivering study-specific training to investigators and site staffSupporting regulatory submissions, audit preparation, and resolution of audit findingsQualificationsMD, PharmD or MSc1+ year of independent on-site monitoring experience in UkraineExperience in all types of monitoring visits in Phase II and/or IIIExperience in Oncology/Ulcerative Colitis/Antibiotics trials is a plusFull working proficiency in English and UkrainianProficiency in MS Office applicationsAbility to plan, multitask and work in a dynamic team environmentCommunication, collaboration, and problem-solving skillsAbility to travelAdditional InformationThis is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy applyI'm interestedI'm interestedPrivacy Notice
