Thermo Fisher / PPD
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
FSP_Clinical Research Associate (Sponsor: Biogen) ─ with Sign-on Bonus
This individual ensures that clinical studies are conducted at investigator sites in compliance with:
• the current approved protocol and any protocol amendment(s),
• ICH GCP
• PPD Written Standards
• applicable local laws and regulatory requirement(s)
so that the rights, safety and well-being of human subjects is protected and that the reported study data is accurate, complete, and verifiable from source documents.
Thrive in multi-national project teams and be focused on delivering exemplary levels of customer service on multiple, exciting projects.
Have excellent communication and social skills and are looking to work in a collegiate environment where you want to take true ownership for your work.
Perform and coordinate all aspects of the clinical monitoring process. You shall also be qualified to conduct monitoring activities independently.
Benefit from award winning training programmes that will assist your technical and professional skills and knowledge.
Keys to Success:
Education - University degree in a nursing / life-sciences field
Experience - Experience of independent, on-site monitoring experience in a Pharmaceutical or Clinical Research Organisation ( at least for 3 years )
Knowledge, Skills, Abilities- 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