Senior Clinical Research Associate

As a Senior CRA at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.

Office-based/Hybrid in Seoul, South Korea

Responsibilities

• Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits
• Act as the main line of communication between project team, Sponsor and the site
• Ensure that subject recruitment targets and project timelines are met at site level
• Perform CRF review, source document verification, drug accountability, and query resolution
• Facilitate the flow of site documents, assist in maintaining study-specific and corporate tracking systems
• Support Study Startup and Regulatory teams in preparation of draft regulatory and ethics committee submission packages 
• Conduct project-specific training of Investigators, prepare Investigator newsletters
• Participate in study site audits and client onsite visits, as required
• Monitor project timelines and patient enrollment, implements respective corrective and preventive measures
• Support junior Monitors in the query resolution process, including Central Monitoring observation
• Coordinate safety information flow and protocol/process deviation reporting
• Perform clinical supplies management with vendors
• Support site contracting and payments
• May lead project team calls on a country level