[ÀÌÈñÁ¤] ¿ÜÀÚCRO - CRA / Sr.CRA ¸ðÁý

Date 02/11/2010   Hits 1337

1. ÀÇ·Ú»ç: À¯¸í ¿ÜÀÚ CRO

2. ¸ðÁý ³»¿ë : Clinical Research Associates / Senior Clinical Research Associates ¸ðÁý

Job Functions:
- Assist in managing large scale clinical trial projects or function as project manager for small scale projects, ensuring on-time, on-budget performance
- Monitor (pre-study, initiation, routine, and close-out visits) investigator sites for GCP compliance according to CRO SOPs and/or client guidelines
- Recruit investigators
- Negotiate study budgets with investigators
- Obtain, review, and process regulatory and administrative documents from investigator sites
- Review and develop protocols
- Review and develop CRFs
- Coordinate and present at Investigators¡¯ Meetings
- Participate in proposal meetings with potential clients
- Prepare and review Serious Adverse Event (SAE) reports
- Prepare project management reports for clients, project personnel, and CRO management
- Resolve issues, questions, and requests for additional study supplies
- Review and approve monitoring trip reports
- Review and verify completed CRFs
- Review clinical data in-house
- Resolve queries of CRF data with study site personnel
- Review Tables and Listings generated from study data
- Author Clinical Study Reports
- Train and mentor CRAs on monitoring, internal procedures, and query resolution

Minimum Requirements :
- Bachelor¡¯s Degree or RN
- Two years¡¯ work experience in clinical research, data management, regulatory affairs, or other relevant healthcare research position
- Eighteen months¡¯ experience in field monitoring of clinical trials.
- Excellent written and verbal communications skills
- Ability and willingness to travel up to 50%
- Excellent organizational skills and ability to manage time and work independently

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¿¬¶ôó : 02-567-7407,7408
À̸ÞÀÏ : yskim@jhhr.co.kr