Senior Clinical Research Associate

Summary

Join PSI as a Senior CRA and work on the frontline of communication with project stakeholders, ensuring timelines, targets, and standards of clinical research projects.

Requirements

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• Independent on-site monitoring experience in USA (5 years minimum)
• Experience in all types of monitoring visits in Phase II and/or III
• Participation in clinical projects as a Lead/Senior Monitor
• Experience monitoring complex Oncology (breast cancer) 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)

Responsibilities

• 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