Senior Clinical Research Associate

Summary

Join PSI, a dynamic global company, as a Senior CRA and work on the frontline of communication with project stakeholders, ensuring timelines, targets, and standards of clinical research projects. You will build and maintain relationships with clinical sites and investigators, focusing on subjects’ rights, safety, and well-being, and quality of data compliance. This role involves conducting monitoring visits, study startup, CRF review, source document verification, query resolution, site communication and management, and supervising study activities. You will also be a point of contact for support services and vendors, participate in quality control, feasibility research, and regulatory document preparation. Advance your career in clinical research with a company that prioritizes its people.

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