Junior Clinical Research Associate
Job content - You manage clinical trials from start to finish: you carry out pre-study visits, you initiate the trial, you are responsible for routine monitoring and closing visits about the quality standards and timelines
- You obtain and update essential documentation in compliance with ICH-GCP, Procedural Documents and local regulations both in a Trial Master File (eTMF) and Investigator Study File (ISF)
- You actively participate in Local Study Team meetings
- You train, support and advise investigators and site staff about study-related matters
- You contribute to Investigators meetings
- You initiate, monitor and close study sites in compliance with procedural documents. You share information on patient recruitment and study site progress with Local Study Teams
- You are in charge of performance at the site. You proactively identify study-related issues and find the appropriate solutions
- You update the CTMS system and other systems with data from centers, respecting deadlines
- You carry out source data verification according to the SDV plan
- You ensure data query resolution on site
- You are responsible for accurate and timely reporting of Serious Adverse Events on site
- You prepare and participate in activities related to audits and regulatory inspections
- You provide the required monitoring visit reports, meeting the requested deadline
Profile - A first working experience within clinical research such as Clinical Trial Assistant or as a CRA is required
- Master degree in Life Sciences
- You are fluent in French and/or Dutch and English (written and spoken skills)
- Advanced knowledge of MS Office Excel
- You have strong communication skills and are able to build relations with the on-site staff and the internal staff (PM, CRAs, CTAs, medical advisor etc.)
- You are flexible and easily adapt to new ways of working or new projects
- You are capable of working independently
- You can set and manage priorities
- You are well-organised and able to work efficiently and effectively in a dynamic environment