We are looking for a Clinical Research Associate (CRA) to join our Compliance and Regulatory Affairs (RA) team. Compliance and RA team is responsible for the companys clinical and regulatory activities, quality management systems, and for ensuring compliance with applicable standards.
The team plays a central role in both pre-market and post-market activities. The CRA will play an important role, working with clinical sites, ensuring successful management of clinical activities, and performing assigned monitoring activities throughout the clinical trial lifecycle.
Your responsibilities will include:
Managing global clinical trials at multiple clinical sites, taking part in planning clinical studies, defining clinical protocols, and supporting regulatory documentation.
Collaborating with multiple stakeholders to ensure successful, rigorous, and timely studies.
Proactively managing clinical study processes and monitoring activities. Overseeing and supervising clinical operations to ensure activities are carried in accordance with applicable regulatory requirements and guidelines.
Maintaining strong relationships with external experts to ensure effective execution of clinical studies and research projects.
Taking part in defining and approving clinical study protocols and plans, IRB submission documents, CRFs, and clinical study reports.
Facilitating team training per study protocols and supporting regulatory submission and documentation.
Requirements: Relevant bachelors degree (Biotechnology Engineering, Biomedical, Life Science/Exact Science)
2+ years of experience managing clinical trials, in-vitro diagnostics-related (IVD) preferred
Working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential
GCP/CRA certification preferred
Familiarity with medical device and IVD RA preferred
Understanding of quality assurance processes and methodologies (ISO 13485:2016, ISO 9001:2015 or similar) preferred
A collaborative attitude
Independence and self-motivation
Excellent communication skills (written and verbal)
Strong attention to details
English proficiency
This position is open to all candidates.
