Key Responsibilities:
- Site Monitoring:
- Conduct site initiation visits (SIV) and close-out visits (COV).
- Perform ongoing site monitoring to ensure compliance with study protocols and regulatory requirements.
- Principal Investigator (PI) Management:
- Maintain effective communication and collaboration with PIs and site staff.
- Ensure timely resolution of site issues and queries.
- Audit & Inspection:
- Prepare sites for regulatory audits and inspections.
- Address audit findings and implement corrective actions.
- NDCT Rule Compliance:
- Ensure adherence to the New Drugs and Clinical Trials (NDCT) rules.
- Keep updated with changes in regulatory requirements and guidelines.
Qualifications:
- Pharm D or equivalent degree.
- More than 1.5 years of site monitoring experience.
- Good communication skills, both verbal and written.
