ICON Job Posting: Clinical Research Associate II
Company: ICON plc
Location: Bangalore (Hybrid)
Salary: ₹25,000 – ₹35,000 / month
Experience: 1 to 2 Years
Qualification: B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences
About ICON:
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing outsourced services to pharmaceutical, biotechnology, medical device, and government and public health organizations. Our mission is to accelerate the development of drugs and devices that save lives and improve quality of life, placing patients at the center of all that we do.
Position Overview:
As a Clinical Research Associate II at ICON, you will conduct site monitoring, manage Principal Investigator (PI) relationships, prepare for audits, and ensure compliance with NDCT rules.
Key Responsibilities:
- Site Monitoring:
- Conduct site initiation visits (SIV) and close-out visits (COV).
- Perform ongoing site monitoring for protocol and regulatory compliance.
- Principal Investigator (PI) Management:
- Maintain effective communication with PIs and site staff.
- Resolve site issues and queries promptly.
- Audit & Inspection:
- Prepare sites for regulatory audits and inspections.
- Address audit findings and implement corrective actions.
- NDCT Rule Compliance:
- Ensure adherence to New Drugs and Clinical Trials (NDCT) rules.
- Stay updated with regulatory changes and guidelines.
Qualifications:
- Pharm D or equivalent degree.
- More than 1.5 years of site monitoring experience.
- Good verbal and written communication skills.
Key Responsibilities Table:
| Responsibility | Description |
|---|---|
| Site Monitoring | Conduct SIVs and COVs, ongoing monitoring for protocol and regulatory compliance. |
| PI Management | Communicate with PIs, resolve site issues and queries. |
| Audit & Inspection | Prepare for audits, address findings, implement corrective actions. |
| NDCT Rule Compliance | Adhere to NDCT rules, stay updated with regulatory changes. |
