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FSP CRA

About the role

• Ensure clinical studies are conducted at investigator sites in compliance with approved protocols and amendments, ICH GCP, client/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
• Perform and coordinate all aspects of the clinical monitoring process
• Conduct monitoring activities independently
• Work within multinational project teams
• Deliver exemplary customer service across multiple projects
• Take ownership of assigned work

• University degree in a nursing / life-sciences field
• At least 2 years of independent, on-site monitoring experience in a pharmaceutical company or clinical research organisation
• Understanding of ICH-GCP, MFDS and FDA requirements
• Understanding of medical/therapeutic area knowledge and medical terminology
• Exceptional communication, collaboration, organizational and time management skills
• Fluency in English

• Sign-on bonus
• Award-winning training programmes
• Technical and professional skills development