CRA II (FSP) Denmark

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

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• Perform and coordinate all aspects of the clinical monitoring and site management process
• Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation
• Manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.)
• Act as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects rights, well-being, and data reliability
• Ensure audit readiness
• Develop collaborative relationships with investigational sites

• Bachelor's degree in a life science related field or a registered nursing certification or equivalent and relevant formal academic/vocational qualification Knowledge

• Valid driver's license
• Well-developed critical thinking skills, including but not limited to: in-depth investigator for appropriate root cause analysis and problem solving
• Good oral and written communication skills - both English and Danish/Swedish
• Good listening skills, attention to detail and the ability to perceive customers' underlying issues
• Good organizational and time management skills
• Effective social skills
• Ability to remain adaptable in a wide range of scenarios
• Ability to work in a team or independent as required
• Good digital literacy - Microsoft office plus the ability to learn appropriate software