Job application due on 2010-08-22
Sr. CRA in Medical, BSP
Job Description:
- Manages and is responsible for all aspects of monitoring and site management from site selection to clean database to site close-out for assigned R&D clinical trials
- Ensures site compliance with the study protocol, international and local regulatory requirements and all applicable company procedures
- Performs as the Country Lead Monitor role for assigned studies. CLM is responsible for and overseeing the study progress within his/her country and reports to responsible Study Manager.
- Responsible for country level management: work cross-functionally to ensure all documents and timelines are met. Also, plan and track study timelines, enrollment, and budget
- Key contributor in the preparation of site audits and regulatory inspections to ensure a successful outcome
- Comply with pharma regulations and BHC ethical business practices
- Ensures site compliance with the study protocol, international and local regulatory requirements and all applicable company procedures
- Performs as the Country Lead Monitor role for assigned studies. CLM is responsible for and overseeing the study progress within his/her country and reports to responsible Study Manager.
- Responsible for country level management: work cross-functionally to ensure all documents and timelines are met. Also, plan and track study timelines, enrollment, and budget
- Key contributor in the preparation of site audits and regulatory inspections to ensure a successful outcome
- Comply with pharma regulations and BHC ethical business practices
Requirements:
- University graduate, major in Pharmacy, Nursing or Science
- 6-7 years in healthcare experience of which at least 3-5 years of direct monitoring experience as CRA is preferred
- Full knowledge of regulations (e.g., ICH-GCP, KGCP)
- Capability of communicating clinical pharmacology of Bayer Schering Pharma’s products comprehensively and clearly to the investigators
- Good command of written and spoken English
- 6-7 years in healthcare experience of which at least 3-5 years of direct monitoring experience as CRA is preferred
- Full knowledge of regulations (e.g., ICH-GCP, KGCP)
- Capability of communicating clinical pharmacology of Bayer Schering Pharma’s products comprehensively and clearly to the investigators
- Good command of written and spoken English

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