Company Description

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.

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.

Office-based/Hybrid in Seoul, South Korea

Responsibilities

Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visitsAct as the main line of communication between project team, Sponsor and the siteEnsure that subject recruitment targets and project timelines are met at site levelPerform CRF review, source document verification, drug accountability, and query resolutionFacilitate the flow of site documents, assist in maintaining study-specific and corporate tracking systemsSupport Study Startup and Regulatory teams in preparation of draft regulatory and ethics committee submission packages Conduct project-specific training of Investigators, prepare Investigator newslettersParticipate in study site audits and client onsite visits, as requiredMonitor project timelines and patient enrollment, implements respective corrective and preventive measuresSupport junior Monitors in the query resolution process, including Central Monitoring observationCoordinate safety information flow and protocol/process deviation reportingPerform clinical supplies management with vendorsSupport site contracting and paymentsMay lead project team calls on a country level

QualificationsCollege/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experienceSubstantial independent on-site monitoring experienceExperience in all types of monitoring visits in Phase II and/or IIIExperience in feasibility assessment and study set-up process is preferableExperience in Oncology or Hematology therapeutic indications is a plus (preferable)Full working proficiency in English and KoreanPC skills to be able to work with MS Word, Excel and PowerPointAbility to plan, multitask and work in a dynamic team environmentCommunication, collaboration, and problem-solving skillsAbility 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!