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  • 3 days ago

jobs description

• Conduct of clinical research activities independently in accordance to ICH GCP and SOP’s.
- Investigator identification and selection
- Investigator Meeting activities
- Design and review of study material, such as patient information sheets, consent forms, monitoring plans etc
- Timely submission of protocol/consent documents/safety reports for ethics/IRB approval according to local requirements
- Site visits, including Pre study, initiation, monitoring and close out visits
- Maintain all files and documentation pertaining to the studies
- Complete accurate study status reports
- Ensure the correct storage & accountability of study materials and investigational product
- Process case record forms to the required quality standards and timeliness
- Deal with clinical generated queries in a timely manner
- Ensure correct archiving of files on completion of a study
- Maintain patient and sponsor confidentiality
- Co-ordinate and/or participate in feasibility studies for new proposals... as required

• Act in a lead role on a study, assuming additional responsibilities as detailed/documented by the PM, if appropriate

• Project coordination, planning and logistics, including overview of budget and timelines

• Effective Communication:
- Maintain professionalism at all times
- Keep the project manager or designees regularly informed
- Motivate investigators in order to achieve recruitment targets
- Present at meetings as required.

• Recognize, exemplify and adhere to company’ values which center around our commitment to People, Clients and Performance.

• Ability and willingness to travel as and when required by the company.

• Participate in training and mentoring new staff up to Clinical Research Associate level as required

• Assist with marketing the company if and when appropriate
Seoul South Korea


Apply - Senior CRA Seoul