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 :
- Science/Engineering/Medical/Paramedical University or High School qualification
- First 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 independently
- Good written (particularly technical writing) skills
- Good oral communication skills and verbally persuasive
- Familiar with standard IT office tools
- Full driving licence
- Existing right to work in Europe required.
Contract information :
- Oxford Consultant or Freelancer (part-time)
- Some on-site presence required
- Start date in August.
Vacancy number : 26163
