Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global company founded in 1995, we bring together 3000 driven, dedicated and passionate individuals.  We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

PSI’s business is about conducting clinical research of novel medications. We work at the interface of R&D, pharmaceutical industry and healthcare science and provide services to big and mid-sized pharmaceutical companies.  We help our clients to generate data about safety and efficacy of medications and bring the best ones to market.  By conducting global clinical research trials, PSI makes cutting-edge treatment available in drugstores all over the world and helps patients with serious medical conditions to improve or even save their life.  Help us to make sure that PSI medical and business documents are clear to patients, physicians, regulatory authorities, and clients.

We offer an inspiring story of the company that has grown organically from a handful of countries to global presence.  PSI is a mature company with standards and practices, but we do not stand still.  Every day, there is a figurative Everest to climb, and you will not get bored here.

Job Description

We’re searching for a knowledgeable, team-oriented CRA II to manage the clinical aspects of full-service global projects in South Korea, Seoul. As a CRA II at PSI, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications.  You will build and maintain relationships with clinical sites and investigators.  You will focus on subjects’ rights, safety and well-being and quality of data compliance.

Office-Based in Seoul, South Korea

You will:

Conduct and report all types of onsite monitoring visitsBe involved in study startupPerform CRF review, source document verification and query resolutionFacilitate site budgets and contract negotiationsMonitor trial progress on the country levelBe responsible for site communication and managementBe a point of contact for in-house support services and vendorsCommunicate with internal project teams regarding study progressParticipate in feasibility researchSupport regulatory team in preparing documents for study submissions

Qualifications

 

College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experienceIndependent on-site monitoring experience in KoreaExperience in all types of monitoring visits in Phase II and/or IIIExperience in feasibility assessment and study set-up process is preferableExperience in Multiple Sclerosis, Inflammatory Bowel Disease, Oncology, Infectious Diseases is a plusFull 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

This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.