Clinical Research Associate
1. 접수기간 및 접수방법
1) 접수기간
- 2014년 01월 15일 (수) ~ 2014년 01월 28일 (화) 까지
2) 접수방법
- 당사 홈페이지 접수 이용
2. 모집부서
- Medical
3. 업무개요
- All aspects of site management and monitoring activities for Phase I and all Phase II-IV clinical Investigator sites
within the approved Clinical Development Plan(CDP). These global, complex studies are conducted within the
standards set by Bayer Global Development, according to Good Clinical Practices(ICH - GCP)and applicable
regulatory and legal requirements.
- Managing Investigator site and site activities and monitoring site data, to ensure patient safety and ethical and
regulatory compliance necessary to provide quality data required for global regulatory submissions for approval of
drugs.
- Managing Investigator sites to ensure the Investigator and Site Staff meet all aspects of study delivery and
commitments to make certain the operational study execution is on track from site selection to site close out.
- Rigorous regulatory guidelines exist to ensure overall patient safety related to reporting of serious or unexpected
adverse drug reactions. This position is responsible for training the Investigator and site staff on these strict
regulations and procedures for timely reporting and as well as ensuring ongoing compliance.
- This position proactively identifies potential issues and develops site Corrective Actions/Preventive Actions(CAPAs).
- Acting as a key contributor to the Trial Master File and study documents at the country level, ensures essential
documents are appropriate and filed in the Investigator Site File.
- Acting as a key contributor in the preparation, conduct and follow up of Site Audits and Regulatory Inspections to
ensure a successful outcome.
4. 응시자격
- Bachelor’s degree(or equivalent)
- 4 ~ 6 years of relevant healthcare experience including 2 ~ 3 years of monitoring & site management experience.
- In-depth knowledge of the drug development process, local and international regulations, ICH-GCP, drug safety
requirements, data management process and investigator grant parameters
- Awareness and understanding of cultural differences as well as regional operational differences
- Effective written and verbal English communication skills
- Strong oral presentation, interpersonal, decision-making and issue resolution skills
- Effective planning and organization skills, attention to detail and excellent follow through