TheClinical Research Associateis 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 experience (oncology and phase 1 studies highly desirable)Strong 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 offerSalary up to EUR 50,000/annually based on experienceAdditional benefitsOpportunity to develop your career with and expanding companyWho 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.#J-18808-Ljbffr

📌 Clinical Research Associate (Madrid)
🏢 Opis S. R. L.
📍 Madrid