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

Qualifications :

• 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

Additional Information :

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!

Remote Work :

No

Employment Type :

Full-time