About this role

Conduct and report all types of onsite monitoring visits
Be involved in study startup (if applicable)
Perform CRF review, source document verification and query resolution
Be responsible for site communication and management
Supervise study activities, timelines, and schedules on the country level
Be a point of contact for in-house support services and vendors
Be involved in quality control, such as compliance monitoring and reports review
Participate in feasibility research
Support regulatory team in preparing documents for study submissions

College/University degree in Life Sciences or an equivalent combination of education, training & experience
Independent on-site monitoring experience in the USA (5 years minimum)
Experience in all types of monitoring visits in Phase I-III
Participation in clinical projects as a Senior Monitor
Experience monitoring complex Oncology trials required; experience with radiopharmaceuticals and/or breast cancer preferred
Experience monitoring GI studies (IBD, Chron's, UC) is preferred.
Full working proficiency in English
Proficiency in MS Office applications
Ability to plan, multitask and work in a dynamic team environment
Communication, collaboration, and problem-solving skills
Ability to travel up to 80%
Valid driver’s license (if applicable)

Senior Clinical Research Associate

Key skills