Senior Clinical Research Associate at PSI CRO

Seoul, , South Korea -

Full Time

Start Date

Immediate

Expiry Date

05 Jan, 26

Salary

0.0

Posted On

07 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Monitoring, Communication, Collaboration, Problem-Solving, Oncology, Hematology, Regulatory Submissions, Training, Project Management, Data Verification, Patient Enrollment, Document Management, Safety Reporting, Time Management, Teamwork

Industry

Pharmaceutical Manufacturing

Description

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 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!

Responsibilities

As a Senior CRA, you will prepare and conduct site visits, ensuring high-quality standards are maintained. You will act as the main communication line between the project team, sponsor, and site, while also supporting junior monitors and coordinating safety information flow.