PSI is a leading Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry. Originating from Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.

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

• College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
• Substantial independent on-site monitoring experience
• Experience in all types of monitoring visits in Phase II and/or III
• Experience in feasibility assessment and study set-up process is preferable
• Experience in Oncology or Hematology therapeutic indications is a plus (preferable)
• Full working proficiency in English and Korean
• PC skills to be able to work with MS Word, Excel and PowerPoint
• Ability to plan, multitask and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills
• Ability to travel

Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company, that puts its people first!