As a Senior CRA 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.
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
Minimum of 4+ years of independent on-site monitoring experience in the United States
Experience in all types of monitoring visits in Phase II and/or III
Participation in clinical projects as a Lead/Senior Monitor
Experience in monitoring Oncology clinical trials required
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
Valid driver’s license (if applicable)
Telecommuting is allowed.
About PSI CRO
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
You are dynamic. You are curious. You are more than your job. For you, excellence isn’t just a word; it’s the measure for all you do. You’re passionate. Driven. Dedicated. You can’t stand mediocrity. And you might be the team member we're looking for.