Clinical Research Associate

The Clinical Research Associate is responsible for managing and monitoring clinical trials to ensure they are conducted in compliance with study protocols, ICH-GCP, and applicable regulations. This includes site selection, initiation, monitoring, and close-out activities, while ensuring data quality and patient safety. The role reports to the Clinical Project Manager.Key ResponsibilitiesIdentify, assess, and initiate investigational sitesConduct feasibility, pre-study, initiation, monitoring, and close-out visitsEnsure compliance with protocols, SOPs, ICH-GCP, and regulatory requirementsPerform source data verification and ensure data accuracy and completenessMonitor patient recruitment and support sites in meeting targetsEnsure proper reporting of adverse events and protocol deviationsManage investigational product handling, storage, and accountabilityMaintain study documentation (TMF/eTMF, Investigator Files)Write monitoring reports and follow-up communicationsCollaborate with project teams, sponsors, and site staffSupport audits/inspections and mentor junior CRAsRequirementsDegree in a scientific fieldMinimum 2 years’ CRA or clinical trial monitoring experienceStrong knowledge of ICH-GCP, ISO14155, and clinical trial processesGood English and Microsoft Office skillsStrong organizational, communication, and problem-solving abilitiesAbility to work independently and in a teamWhat we offerWe offer a competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company.Please read the information notice on the processing of personal data in the candidates information section of our company website.Who we areFounded in 1998 in Italy and now operating at an international level, OPIS is a full-service science driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.) always contributing to our clients’ challenging achievements. This page is hosted by JazzHR and uses cookies for technical and analytical purposes. For details regarding the processing of your application data by OPIS, please refer to our: Pivacy Policy Candidate Privacy Policy