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 Senior CRA to manage the clinical aspects of full-service global projects in South Korea. As a Senior CRA at PSI, you will work on the frontline of communication with project stakeholders, ensuring the successful conduct of clinical trials in a variety of therapeutic indications. You will maintain the highest quality standards in the industry, while performing and supervising study start-up, clinical monitoring and site management activities on the country/regional level.
Seoul, South Korea
You will:

• Supervise study activities, timelines, milestones, and schedules on the country level.
• Conduct and report all types of onsite monitoring visits.
• Be involved in study set-up, including site contract and budget negotiations.
• Be responsible for site communication and management.
• Ensure consistency of all study processes and identify country differences.
• Oversee maintenance of study-specific and corporate tracking systems.
• Contribute to the development and update of project planning documents, essential documents, and project instructions.
• Be a point of contact for in-house support services, contractors, global cross-functional teams, and vendors.
• Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
• Development of local language materials including local language Informed Consents and translations.
• Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.

Qualifications

• College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
• At least 5 years of independent on-site monitoring experience or an equivalent experience in Korea for SCRA I
• 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 Power Point
• 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!