The Clinical Research Associate will be part of an international team, which will be developing and monitoring MDR-compliant registries for medical devices.

Responsibilities

• 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 to occasional domestic/international traveling as per project needs

Qualifications

Mandatory

• 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