* 담당업무
상세조건 |
● 모집부서
○ Medical
● 접수기간 및 접수방법
○ 접수기간
- 2014년 01월 21일 (화) ~ 2014년 02월 03일 (월) 까지
○ 접수방법
- 당사 홈페이지 접수 이용
● 업무개요
○ Manages phase IV studies including PMS as a Project Manager
○ Maintains timely and effective communication among team members, CRO and site staff. Routinely anticipates/
identifies potential issues and implements corrective actions independently. Keeps project leadership apprised
of team issues, seeking guidance as needed. Demonstrates effective conflict resolution
○ Responsible for site management and site staff performance including: monitors all types of clinical studies
participates in all types of site visits assures compliance with all protocol requirements assures effective
patient identification and recruitment plan is in place assures timely reporting of Adverse Events (AEs)/
Serious Adverse Events (SAEs) and protocol violations ensures proper storage, dispensation, and accountability
of all Investigational Product(s) and trial-related materials regularly reviews the status of the contents of the
site binder exhibits effective time management skills
○ Organize and attends Investigator meetings. May present materials, as requested. Manages with the preparation
of study start-up materials and tools, as requested. Attends medical staff meetings, project team meetings,
teleconference with oversea colleagues, and internal/external clinical training sessions according to the
project communication, monitoring, and/or training plans
○ Completes and submits reports according to SOP/Operational Instructions (OI) or local regulations. Maintains
awareness of key study performance indicators for own sites, e.g. Quality Review Visit Reports, patient
enrollment, and SAEs. Updates study and patient status information. Tracks Investigator payments/milestones.
Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit
○ Conduct site monitoring (including ICF check, source data verification, CRF/safety reports review, study file
review, IP accountability check) to ensure that studies are going well in accordance with protocol, GCP,
relevant guidelines and SOPs.
● 응시자격
○ Bachelor’s Degree of University(or equivalent)
○ Pharmacist or nurse or major in scientific field is preferred
○ Over 1 year of relevant healthcare experience including monitoring & site management
○ Experience in PMS and clinical trial is preferred
- Effective written and verbal English communication skills
- Interpersonal, decision-making and issue resolution skills are required
- Good communication, negotiation and presentation skill
- IT skills: Microsoft word/Excel/PowerPoint
- Comprehensive knowledge of clinical development process and relevant regulations
※ e.g., GCP, SOP, local regulations
- Contract Period: till Sep. 30, 2014
|
