Clinical Research Associate – Sponsor, Biogen

• Ensure clinical studies are conducted at investigator sites in compliance with the current approved protocol and amendments, ICH GCP, PPD Written Standards, and applicable local laws and regulatory requirements
• Protect the rights, safety and well-being of human subjects
• Ensure reported study data is accurate, complete, and verifiable from source documents
• Thrive in multi-national project teams and deliver exemplary customer service across multiple projects
• Perform and coordinate all aspects of the clinical monitoring process
• Conduct monitoring activities independently

• University degree in a nursing / life-sciences field
• At least 3 years of independent, on-site monitoring experience in a Pharmaceutical or Clinical Research Organisation
• Demonstrated understanding of ICH-GCP, MFDS and FDA requirements
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Exceptional communication, collaboration, organizational and time management skill
• Fluency in English languages
• Ability to conduct monitoring activities independently

• Sign-on bonus
• Award winning training programmes that assist technical and professional skills and knowledge