PWe are looking for a Clinical Research Associate (RWE) to support on client of us on a rheumato and a neurology study (both in enrolment stage) and other studies coming their way. Our client work on phase IV and Post-marketing studies, all non-interventional. Willing to join this multinational company and help them ? Apply now !br / br / strongJob description : /strong br / br / To manage and monitor assigned studies and study sites in clinical studies in order to verify that rights and well-being of subjects are protected, the reported study data are accurate, complete and verifiable from source documents and that the study is conducted in accordance with the currently approved protocol/amendments, all relevant processes and procedures and applicable clinical research regulations.br / br / The Clinical Research Associate is accountable to the Affiliate Real-World Evidence Lead for performing the major duties and responsibilities as outlined below.br / br / strongResponsibilities : /strong br / br / To comply with the company's policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of the company.br / Note: This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permanent schedule and is not part of the contract of employment. /pulliPerform pre-study activities (eg. assist in study sites selection process) for all local or global studies (PMOS and non-PMOS) to be conducted in Belgium /liliHelp to write and negotiate financial contracts for sites /liliMaintain local EC tracker for all EC submissions, notifications, approvals related to Local Clinical Studies /liliAs defined in the relevant sections of ICH GCP guidelines and in compliance with SOPs, local SOPs, applicable regulatory requirements and the Monitoring Plan : conduct and document pre-study, initiation, routine monitoring, and close-out visits with investigators and other related research personnel (e.g. research nurses) for the studies assigned to. /liliProvide monitoring reports and appropriate information for local and central tracking systems within the required timelines /liliPrepare, collect, file, maintain and archive the essential documents /liliManage or prepares clinical study submissions to ethics committees. /liliTrack and report site/study status to the ARWEL/CPM/Global study team. /liliMaintain local Essential Documents in Vault Clinical (eTMF) for the studies assigned to /liliFollow-up of Clinical Study Agreements (CSA) until its fully execution /liliBudget / Payment tracking and execution of payments to study sites as defined in the CSA /liliParticipate in preparation activities required for regulatory and QA audits, and assist in formulation of responses to observations pertaining areas of responsibility /liliAct as the main line of communication between the company and the investigator and coordinate distribution of communications to all sites (e.g. newsletters, mailings, etc) /liliManage translation and tracking of translations for appropriate study documents /liliAttend relevant internal and external trainings per training requirements and timelines, document completion. /li /ulpbr / strongRequirements : /strong /pulliScience/Engineering/Medical/Paramedical University or High School qualification /liliFirst CRA experience is required /liliKnowledge of Dutch, French and English (Trilingual is ideal, or at least be able to express him/herself in the second national language) /liliAble to work independently /liliGood written (particularly technical writing) skills /liliGood oral communication skills and verbally persuasive /liliFamiliar with standard IT office tools /liliFull driving licence /liliExisting right to work in Europe required. /li /ulpbr / strongContract information : /strong br / /pulliOxford Consultant or Freelancer (part-time) /liliSome on-site presence required /liliStart date in August. /li /ulpbr / Vacancy number : 26163br / br / br / /p