Clinical Research Associate II/ Senior Clinical Research AssociateFull-timeCompany 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 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.Job DescriptionAs a Clinical Research Associate II/ Senior Clinical Research Associate at PSI, you will play a key role in ensuring the quality, integrity, and compliance of clinical trials across various therapeutic indications. You will act as the main point of communication between clinical trial sites and project teams, building strong relationships with investigators and site staff while ensuring the rights, safety, and well-being of trial participants.Hybrid role in Sofia, BulgariaYour 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 findingsProviding guidance and mentoring to less experienced Clinical Research AssociatesQualificationsDegree in Life Sciences or a related field, or an equivalent combination of education, training, and experienceAt least 1.5 years of independent on-site monitoring experience in Bulgaria, ideally across multiple clinical trialsExperience conducting all types of monitoring visits in Phase I, II, and/or III clinical trialsC2 proficiency in Bulgarian and a good command of English, both written and spokenExperience supporting oncology studies is an advantage, but not essentialGood knowledge of ICH-GCP guidelines and clinical trial regulationsProficiency in Microsoft Office applicationsStrong organizational, communication, and problem-solving skillsAbility to work independently and collaboratively in an international teamValid driver's license and willingness to travel to clinical trial sitesAdditional 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
