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!