We 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 ! Job description : 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. The Clinical Research Associate is accountable to the Affiliate Real-World Evidence Lead for performing the major duties and responsibilities as outlined below. Responsibilities : 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. 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.Perform pre-study activities (eg. assist in study sites selection process) for all local or global studies (PMOS and non-PMOS) to be conducted in BelgiumHelp to write and negotiate financial contracts for sitesMaintain local EC tracker for all EC submissions, notifications, approvals related to Local Clinical StudiesAs 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.Provide monitoring reports and appropriate information for local and central tracking systems within the required timelinesPrepare, collect, file, maintain and archive the essential documentsManage or prepares clinical study submissions to ethics committees.Track and report site/study status to the ARWEL/CPM/Global study team.Maintain local Essential Documents in Vault Clinical (eTMF) for the studies assigned toFollow-up of Clinical Study Agreements (CSA) until its fully executionBudget / Payment tracking and execution of payments to study sites as defined in the CSAParticipate in preparation activities required for regulatory and QA audits, and assist in formulation of responses to observations pertaining areas of responsibilityAct 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)Manage translation and tracking of translations for appropriate study documentsAttend relevant internal and external trainings per training requirements and timelines, document completion. Requirements :Science/Engineering/Medical/Paramedical University or High School qualificationFirst CRA experience is required Knowledge of Dutch, French and English (Trilingual is ideal, or at least be able to express him/herself in the second national language)Able to work independentlyGood written (particularly technical writing) skillsGood oral communication skills and verbally persuasiveFamiliar with standard IT office toolsFull driving licenceExisting right to work in Europe required. Contract information : Oxford Consultant or Freelancer (part-time)Some on-site presence requiredStart date in August. Vacancy number : 26163