Administrative / Clinical Trial Assistant – Italy (Home Based)
We welcome applications from candidates with disabilities.
Clintec is recruiting an Administrative and Clinical Trial Assistant to join our organisation in Italy to support our expanding clinical operations team. This is a permanent and full-time role working home based in any major city across Italy.
By working for Clintec, you can further your career in a dynamic, fast paced environment and you can be assured of rewarding benefits.
Clintec is a dynamic, privately owned clinical research organisation with a presence in over 50 countries and a HQ in the UK. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical devices industries and assisting in their key product development efforts for over 2 decades.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.
The Administrative/Clinical Trial Assistant will be responsible for providing support to the clinical operations team to ensure the successful completion of clinical studies performed on behalf of our clients. The Administrative/Clinical Trial Assistant will be overall responsible for administrative activities ensuring adherence to company procedures, the study protocol and in line with IGH GCP and Italian regulations.
Document Compilation and Archiving:
• Act as the central contact for all members of the Clinical Project Team for the transmission, collation, tracking and filing of project documentation
• Compile and contribute to regulatory submissions & Ethics Committee/IRB submissions in conjunction with the Clinical Project Team
• Ensure project documents are uploaded in the shared company database such as SharePoint
• Accompany CRAs if appropriate to specified sites to ensure that the study site files confirm to the Clintec / sponsor SOPs and in accordance with ICH-GCP and relevant regulatory requirements
• Contribute to the successful running of the Clintec Italian operations
• Provide general administrative and clerical support
• Carry out additional duties to support business activities as required by Clintec
Adherence to Regulatory regulations and laws and ICH-GCP:
• Supervise and monitor clinical trials to ensure adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures
• Read all applicable SOPs, attend trainings as recommended and maintain an accurate updated training log
• Professional manner
• Excellent verbal and written communication skills
• Strong organizational and time management skills
• Competent in all Microsoft Office packages
• Ability to speak English at intermediate level minimum
• Ability to work from home (equipment will be provided)