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Task description
Site Management
- assume on-site monitoring duties and quality audits as needed
- oversee investigator recruitment, qualification and selection
- coordinate inventory and shipment of investigational products, clinical supplies and documents
- overlook patient enrollment and identify/outline patient recruitment strategies
- assure timely reporting of AEs/SAEs
- report appropriately Protocol Violations/Deviations
- assure compliance with ICH and GCP guidelines , CFR and State regulations, Sponsor and KasaConsult SOPs
Data Handling- perform source document verification according to contractual requirements
- assure timely completion and submission of CRFs according to Clinical Monitoring Plan and/or Data Managing Plan
- assure timely and accurate completion of Data Clarification Forms
Reporting and Tracking- complete and submit visit trip reports
- maintain awareness of key study performance indicators
- update study and patient status information and serve as resource
- track investigator payments
- document and track the resolution of all outstanding site-specific protocol-related issues from visit to visit.</il>
Regulatory Submissions and Documentation- perform or assist with submission of clinical trial dossiers and documents to Competent Authorities (CA) and Ethics Commitees (EC)
- understand the EC/CA submission process in Belgium, The Netherlands and France
- maintain current regulatory documentation
Communication- maintain timely and effective communication among team members and site staff
- assure timely and detailed feedback to sponsor
- organize and present on project and investigator meetings
Profile- excellent in social and interpersonal contacts
- able to handle multiple tasks to meet deadlines
- motivating people (coaching, counseling, mentoring)
- customer-oriented, enthousiastic, dynamic
- willing to travel
Education, knowledge and experience- Msc Biomedical Sciences, Msc (Para) Medical Sciences, or equivalent by experience
- minimum 1-2 year of experience in a similar function and/or in a CRO,in the pharmaceutical/medical device, in the biotechnology sector
excellent in Dutch, French and English (spoken as well as written)- experience in Microsoft
Our offer
KasaConsult offers you a challenging job with an interesting salary and extralegal benefits within a pleasant work atmosphere and on a location without traffic jams.
Possibility of development of your personal skills via courses.
Please send your reaction preferably by e-mail to k.seldeslagh(at)kasaconsult.com
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