大手医薬品開発支援企業でのSenior CRA【ソウル勤務】の求人

This is a position for experienced Senior CRA to be based in the Seoul office, Korea.

In general, this person will support project management, clinical monitoring and/or regulatory affairs in all aspects of the project, support study start up activities, assist project teams in project administrative tasks, and to support Project Manager and Project Team as required.

【Job responsibilities】
●Responsible to support project team(s) on all project-related issues to ensure all activities are conducted in highest quality standards, in compliance with ICH E6 CGP, local GCP and applicable local regulatory requirements as well as meet/exceed sponsor’s expectation, under the supervision of project manager(s)
●Support to develop, compile and/or review all study-related regulatory and administrative documents from investigational sites, monitoring visit reports, work progression reports and other study-required documents
●Support to develop, compile and/or submit dossiers to regulatory and/or ethics committee for review and follow up until approval, if required
●Support in safety reporting to regulatory and/or ethics committee as required
●Support in planning, coordinating, organizing and attending all study-related meetings and activities for sites, as required
●Support in regulatory/product research, consultancy tasks, feasibility studies, site and investigator identification as required
●Support project(s) in the capacity of Project Assistant and undertake all or partial responsibilities and tasks as designated by the Company and in compliance to ICH E6 GCP, local GCP, applicable local regulatory and project requirements
●Support/Assist in Site and CRO audit or inspection as required
●Assist to set up, review and maintain project files to ensure compliance to ICH E6 GCP, local GCP, applicable local regulatory and project requirements
●Support in Company/departmental administrative work as required
●Set up, maintain new/existing projects

【MUST】
●Minimum of 2 to 4 years of clinical monitoring experience in various therapeutic areas
●Minimum diploma or bachelor degree (major in nursing, pharmacy, or other science related background) from a recognized institution, and/or equivalent combination of training and experience
●Strong computer/technology skills including MS Word, MS Excel and PowerPoint
●Good written and verbal communication skills, preferably with good command of English in addition to Korean language
●Good organizational and interpersonal skills
●Self-initiative to perform duties
●Meticulous and able to work in a fast-paced environment
●Good team-player
●Ability to multi-task and follow through with assigned tasks
●Good knowledge of ICH/GCP guidelines, SOPs and other applicable regulations
●Must have native level Korean language skills

【Ideal skills, if have】
●English language skills
●Japanese language skills
※ For those who are seeking to return to Korea, this would be a very good opportunity where you can help contribute your CRA skills.