Senior Clinical Research Associate
Senior Clinical Research Associate
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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.
Officebased/Hybrid in Seoul South Korea
Responsibilities
- Prepare conduct and report site selection initiation routine monitoring and closeout 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 studyspecific and corporate tracking systems
- Support Study Startup and Regulatory teams in preparation of draft regulatory and ethics committee submission packages
- Conduct projectspecific 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 onsite monitoring experience
- Experience in all types of monitoring visits in Phase II and/or III
- Experience in feasibility assessment and study setup 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 problemsolving 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 :
Fulltime
Employment Type
Full-time
