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. Build and maintain relationships with clinical sites and investigators, focusing on subjects’ rights, safety, and well-being, and quality of data compliance. Conduct and report all types of onsite monitoring visits, participate in study startup, perform CRF review, and resolve queries. Supervise study activities and be a point of contact for support services and vendors. Contribute to quality control and participate in feasibility research. Support the regulatory team in preparing documents for study submissions. This role offers opportunities for career advancement and hands-on involvement in all aspects of the study.

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