Clinical Research Associate (RWE)

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 Belgium
• Help to write and negotiate financial contracts for sites
• Maintain local EC tracker for all EC submissions, notifications, approvals related to Local Clinical Studies
• As 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 timelines
• Prepare, collect, file, maintain and archive the essential documents
• Manage 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 to
• Follow-up of Clinical Study Agreements (CSA) until its fully execution
• Budget / Payment tracking and execution of payments to study sites as defined in the CSA
• Participate in preparation activities required for regulatory and QA audits, and assist in formulation of responses to observations pertaining areas of responsibility
• Act 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 documents
• Attend relevant internal and external trainings per training requirements and timelines, document completion.

Requirements :

Contract information :

Vacancy number : 26163