외국계유명제약사) CRA

[근무회사 및 모집부문]
* 근무회사: 외국계 중견 제약사
* 회사정보: 삼성역 소재 미국계 기업
* 담당업무: CRA
* 특이사항: 육아휴직대체

[업무내용]
• Identifies new potential Investigators, through ongoing collaborations with medical monitors (including local
staff), field medical personnel, and other medical contacts. Assess potential Investigators and their sites.
Documents the visit, and communicate findings. Provides feedback on Potential Site Assessment findings to
collaborators.
• Recommends sites for consideration in future studies, as needed.
Expedites the pre-study and study initiation processes including the conduct of Pre-Study Evaluation and Site
Initiation visits. Conducts initiation visits in collaboration with Clinical Site Managers, Field Medical and/or
Protocol Managers. Orients and trains site personnel regarding the protocol, study related processes and
procedures and applicable regulatory requirements.
• Reviews site activities and quality through on-site visits in addition to emote management capabilities.
Monitors study sites following the monitoring plan, Company's SOPs, protocol, ICH/GCP Guidelines and other local
regulations as applicable. This includes, but is not limited to: Managing multiple protocols, across multiple
therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
• Ensures safety and protection of study subjects according to the monitoring plan, SOPs, and ICH/GCP
Guidelines and local regulations. Ensures quality of data submitted from study sites and assures timely
submission of data by using the available systems to follow site activities.
• Supervises overall activities of site personnel over whom there is no direct authority. Motivates/influences them
to meet study objectives, including enrollment and retention goals. Resolves study site problems/issues as
they occur. More complex issues may be resolved jointly with management. Initiates, recommends,
documents and communicates corrective actions as needed and follows up to ensure corrective actions are
implemented.
• Ensures documented follow-up to all outstanding issues/corrective actions, within the scope of this position
profile, in the available systems. Appropriately documents and promptly escalates serious or persistent
outstanding issues to management and project team.
• Facilitates the Regulatory Compliance audit process, as needed.
Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise,
professional and objective manner.
• Identifies opportunities to interact, builds and strengthens professional and collaborative relationships with all
internal and external stakeholders (e.g., site and institutional personnel, Thought Leaders, internal colleagues,
etc.).
• Uses multiple technologies to maintain open and frequent communication with all stakeholders.
• Exhibits flexibility and adaptability when facing change.
• Employs good fiscal management for travel expenses, etc.
• Ability to perform site management activities, as required.
• Performs other tasks, as assigned or requested by line manager.

[지원자격]
- 대졸 이상
- CRA 경력자 우대 

- 유관 전공자

[근무환경]
- 계약기간: 1년2개월가량 (파견계약직 / 육아휴직대체)
- 근무지: 대치동 (삼성역 부근)
- 근무시간: 09:00 ~ 18:00 (주 5일)
- 급여: 경력별 협의
- 복리후생: 4대 보험, 연차, 명절선물, 생일선물, 자기계발 지원, 경조사 지원 등

[지원방법]
- 이메일 지원: yuhwon@manpower.co.kr
- 이메일 제목: CRA_지원자 본인 성함 기재
- 제출서류: 국/영문 이력서 및 자기소개서 (MS Word 양식)
- 담당자: 이여원 과장, 02-6420-0334