Job Purpose

To perform/manage clinical operations including site selection, initiatioin, monitoring and close out in accordance with the scope of Good Clinical Practices.

The Role :

ㆍResponsible for managing/overseeing CROs in an assigned study during set-up period, monitoring period and close out period/data management.

ㆍResponsible for reviewing documentations generated for/during an assigned study including RSV/SIV reports, IRB, ICF, CRFs, monitoring visit reports any other regulatory documents, manuals/policy and SOPs etc.

ㆍResponsible for reporting status/issues of assigned studies during clinical operations.

ㆍResponsible for monitoring IP management (shipment, storage and accountability)

ㆍParticipate in global/local task forces and initiatives.

ㆍEnsure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving global regulations, guidelines and policies. Monitor regulatory reforms and industry trends and provide impact analysis of significant changes affecting conduct of Clinical studies.

Skills, Experience, Education and Certifications :

ㆍBachelor’s or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred

ㆍQualified CRA training from global authorities certified associations

ㆍLanguage: Fluent in English

ㆍStrong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.

ㆍExcellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity.

ㆍDemonstrated proactive and positive team player.

ㆍ Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment, with experience participating global projects with competing deadlines; Experience across multiple Therapeutic Areas and Study Phases.

ㆍ Drives continuous improvement and simplicity in process and approach and enhances agility.

ㆍ Demonstrated business ethics and integrity.

ㆍ There are overseas business trips for global clinical operation (~30% of a year)

[자격요건]

ㆍ 학력 : 대졸 이상 (4년)

ㆍ 경력 : 신입, 0~5년 (사원~과장급)

ㆍ 언어 : 영어 (fluent)

ㆍ 특이사항 : 해외 출장 가능 인력(~30%), 국내 및 해외 임상 참여 3년 이상

ㆍ 우대사항 : 관련학과(생명과학, 의/약학, 간호학 등), 안과 질환 치료제 경험자 우대 등등