Job Description
Your challenge
Responsibility:
• Monitoring of external and internal clinical performance evaluations and internal clinical trials (development studies, post-marketing complaints/observations)
• Preparation of relevant documents for clinical trials according to project requirments and internal processes
• "Preparation of study documents (e.g. templates/protocols)
• "Review of study documents (e.g. templates/protocols)
• Performance of site initiations, on-site monitoring, monitoring GBO-lab, remote monitoring and close-out visits
• Communication with investigators, opinion leaders, consultants, CRO, suppliers
• Filing of documents, TMF maintainance
• Training of study team members in accordance with protocol specific requirements and (local) regulations
• Support the (international) trials submission to authorities and ethics committees
• Ensuring the accuracy, validity and completeness of study data
• Trial sites feasibilities
Your Profile
Job Requirements:
• University degree in biology, medicine, pharmacy or an equivalent combination of education, training and work experience in clinical trials
• At least 2 years of experience as a clinical research associate/ clinical monitor in a CRO/medical device or pharmaceutical company
• Good knowledge of current industry practices related to the conduct of clinical trials (ICH-GCP, ISO14155, ISO 20916)
• Good knowledge of MDR and IVDR, as well as good understanding of GDPR
• Experience with FDA, ISO regulations and CLSI guidelines an advantage
• Ability to work independently and reliably in a fast-paced and changing environment
• Excellent communication skills are a must
• Travelling required
• Driving license