Senior Clinical Research Associate

As a Senior Clinical Research Associate you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. You will focus on subjects’ rights, safety and well-being and quality of data compliance.
You will:
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)
For this position PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

Employment type
Full-time

Work arrangement
Yes