Looking for your new role in Clinical Research as a Clinical Research Associate?
Interested to join an international, multicultural corporation that takes pride in its innovative projects within the medtech industry?
Then, send us your CV! Evnia is looking forward to meeting you!
The Clinical Research Associate will be part of an international team, which will be developing and monitoring MDR-compliant registries for medical devices.
- Establishing strong, dynamic communication with principal Investigators and administration personnel
- Full ownership and maintenance of site-related activities including, quality oversight visits during initiation, regular monitoring and close-out, in accordance with the clinical monitoring plan
- Entering and Managing data in an online platform of data management (recruitment, case report form (CRF) completion, and data query resolution)
- Ensure that all ICH-GCP, ISO14155, and MDR requirements are met
- Other duties may be assigned to this role depending on project-specific needs.
- Ability for occasional domestic/international traveling as per project needs
- University degree in Health Sciences including Biology/Chemistry/Nursery etc
- Prior experience of at least 3 years working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
- A solid, working knowledge of ICH-GCP guidelines, ISO 14155 requirements and local and international regulatory requirements is essential.
- Fluent in English plus local language requirements. Other languages will be appreciated.
- PC literacy including expertise in MS Office Suite and study systems e.g., eCRF, ePRO, CTMS, etc.
Good to have
- Prior experience as CRA with independent monitoring experience of registries and/or observational studies
- Prior experience/exposure to the Medical Device Regulation for medical devices