PClinical Research Associate (CRA) is responsible for coordinating and overseeing the execution of /ppclinical studies, mainly observational, and clinical investigations under the supervision by the Project /ppManager: identify, select, initiate and close-out appropriate investigational sites for clinical studies /ppand clinical investigations. To monitor those sites to ensure that studies are carried out according to /ppthe study protocol and in accordance with CRO/Sponsor SOPs/Wis, any applicable regulations and /ppstandards and the principles of ICH GCP, as applicable. /ppbr / /ppbr / /ppbr / /ppstrongSome of what you'll do: /strong /ppbr / /pulliMaintain patient and Sponsor confidentiality. /liliParticipate in the feasibility process of new studies/clinical investigations, collect feasibility questionnaire (if applicable) and other documents necessary for the ethical and administrative /li /ulp submission. /pulliPerform pre-study/selection visits; br / verify that the Investigator and staff are qualified for the study and have sufficient available time and resources/facilities; br / verify that the Site issuitable with regard to its structure, instruments and the availability of patients affected by the pathology being studied. /liliPerform initiation visits; br / ensure that the Investigator and staff have adequate training on study protocol and all related procedures, including the Investigational Medicinal Product/Investigational Product/Medical Device and the ICH-GCP, ISO1455 and any other applicable standards. /liliEnsure that essential documents are correctly signed and managed. /liliInteract with the Regulatory and submission team and support in collecting the documents or information necessary for the ethical and administrative submission. /liliCheck that the enrolment schedule is in line with the study plan/projections and motivate /liliInvestigators to achieve the planned recruitment targets. /liliEnsure delivery of study materials and products are available prior to study initiation. /liliOngoing management of study materials, including study product(s), as foreseen for the specific study and as applicable (product supply and return, CRFs, laboratory material and samples, study documents, etc.). /liliConduct regular on site and remote monitoring visits in accordance with the Monitoring Plan, the contract, OPIS/Sponsor SOPs/WIs as appropriate. /liliContact Sites to check patient status, resolve queries and deal with various issues. /liliEnsure that all the activities are managed in due time and timelines are respected. /liliEnsure accuracy and completeness of data entered into OPIS/Sponsor systems and ensure that /lilithe confidentiality of the patient is respected. /liliPerform source data verification according to the Monitoring Plan or other similar documents. /liliVerify that Adverse Events and Serious Adverse Events have been reported according to OPIS and/or Sponsor procedures and in adherence to regulatory requirements. /liliEscalation of significant or critical issues according to the relevant procedures. /liliManage queries on an ongoing basis and within the timeframes set. /li /ulpbr / /ppbr / /ppbr / /ppstrongWhat we're looking for: /strong /ppbr / /ppbr / /pulliDegree in a scientific field /lili0-12 Months of experience as CRA /liliKnowledge of ICH-GCP and ISO14155 and techniques for the monitoring of clinical studies and clinical investigations. /liliObtain requirements as per local regulation (e.G., for CRA working in Italy, of Ministerial Decree in order to conduct interventional clinical trials) /liliAble to carry out all the activities related to the monitoring of clinical trials/clinical investigations, guaranteeing the security of information /liliGood knowledge of Office Suite /liliGood knowledge of English language /liliAble to work independently under the supervision of the Project Managers and Clinical Operations Managers /liliAble to interact with the personnel of clinical studies and clinical investigations /li /ulpbr / /ppbr / /ppbr / /ppstronguWho we are: /u /strong /ppbr / /ppFounded 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. /ppOPIS 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. /ppbr / /ppbr / /ppstronguWhat we offer: /u /strong /ppbr / /ppemWe offer a competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company. /em /ppPlease read the information notice on the processing of personal data in the candidates information section of emour company website. /em /p