ppWe are looking for a motivated Clinical Research professional to join our Clinical Operations team. This role is designed for someone with a scientific/life sciences degree and initial experience in clinical research, such as a Clinical Trial Assistant (CTA), Clinical Research Coordinator, Study Coordinator or similar position, who is looking to develop their career into a CRA role. /p pThe successful candidate will initially work as a non-certified CRA, receiving the required induction and clinical research training, including the CRA course where applicable. Once the required training and CRA certification have been successfully completed, the role will progress into a CRA position, with responsibility for monitoring clinical studies. /p h3Key responsibilities: /h3 ul liSupport the planning, set-up and conduct of clinical studies, primarily observational studies and clinical investigations. /li liSupport site identification, selection, initiation and close-out activities. /li liDevelop knowledge and practical experience in clinical trial monitoring under the supervision of a Project Manager. /li liSupport on-site and remote monitoring activities in accordance with study protocols, SOPs, ICH-GCP and applicable regulations. /li liMaintain communication with investigators and site staff and follow up on study-related queries and activities. /li liReview and maintain essential study documentation, Investigator Files and TMF/eTMF. /li liSupport regulatory and ethics submissions by coordinating required documentation. /li liMonitor study timelines, recruitment, site performance and key study metrics. /li liSupport the identification and follow-up of protocol deviations and other study issues. /li liPrepare study documentation, visit reports and follow-up communications. /li liParticipate in Sponsor, Investigator and Monitor meetings as required. /li liComplete all required training and maintain accurate study, time and expense records.



/li liMaintain confidentiality and ensure compliance with applicable regulations, SOPs and quality standards. /li /ul h3Requirements: /h3 ul liDegree in a scientific, life sciences or healthcare-related field. /li liInitial experience in clinical research, ideally as a CTA, Clinical Trial Coordinator, Study Coordinator, Clinical Research Coordinator or similar. /li liNo prior CRA certification required – full training and development will be provided. /li liStrong organisational, communication and interpersonal skills. /li liAbility to manage priorities and work independently while receiving guidance from the Project Manager. /li liGood knowledge of Microsoft Office. /li liGood level of English. /li liWillingness to travel for site visits as required /li liOffice based in Desio, Milan whilst conducting trainings /li /ul h3Career progression: /h3 pThis position provides a structured pathway from a non-certified CRA role to a certified CRA position following completion of the required training and certification. /p h3What we offer /h3 pWe offer a competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company. /p h3Who we are /h3 pFounded 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. /p pOPIS 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. /p /p #J-18808-Ljbffr

📌 Clinical Research Associate (Milano)
🏢 Opis
📍 Milano