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1. All aspects of site management and monitoring activities for assigned applicable 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.

2. 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.

3. 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.

4. Rigorous regulatory guidelines exist to ensure overall patient safety related to reporting of serious or unexpected adverse drug reactions. The CRA II 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. Strict adherence is essential to remain complaint with on time reporting from Bayer to regulatory authorities and critical for thorough and timely evaluation of patient safety.

5. Due to the highly regulated clinical trial environment, the CRA II proactively identifies potential issues and develops site Corrective Actions / Preventive Actions (CAPAs). The CRA II ensures timely and sufficient resolution of issues that may impact compliance or quality of study related activities or data.

6. As key contributor to the Trial Master File and study documents at the country level, ensures essential documents are appropriate and filed in a timely manner in the Investigator Site File.

7. Incumbent is a key contributor in the preparation, conduct and follow up of Site Audits and Regulatory Inspections to ensure a successful outcome. The CRA II is a member of the audit/regulatory inspection team.

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- Bachelor¡¯s Degree (or equivalent) with 4-6 years of relevant healthcare experience including 2 - 3 years of monitoring & site management experience.

- In-depth knowledge of the drug development process including monitoring and site management, local and international regulations and international regulations, ICH – GCP, drug safety requirements, data management processes 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 are required.

- Effective planning and organization skills, attention to detail and excellent follow through.