Clinical Research Associate – Sponsor, Biogen

This is a fully remote position, open to applicants in South Korea.

📋 Description

• Ensure that clinical studies are executed at investigator sites in accordance with the current approved protocol and amendments, ICH GCP, PPD Written Standards, and relevant local laws and regulatory requirements.

• Safeguard the rights, safety, and well-being of human subjects involved in the studies.

• Ensure that the reported study data is accurate, complete, and can be verified against source documents.

• Excel in multi-national project teams and provide outstanding customer service across various projects.

• Oversee and manage all facets of the clinical monitoring process.

• Carry out monitoring activities autonomously.

⛳️ Requirements

• Bachelor's degree in nursing or a life sciences field.

• Minimum of 3 years of independent, on-site monitoring experience in a pharmaceutical company or clinical research organization.

• Proven knowledge of ICH-GCP, MFDS, and FDA standards.

• Solid understanding of medical and therapeutic area knowledge as well as medical terminology.

• Outstanding communication, collaboration, organizational, and time management abilities.

• Proficiency in the English language.

• Capability to perform monitoring activities independently.

🏝️ Benefits

• Sign-on bonus.

• Award-winning training programs that enhance technical and professional skills and knowledge.