Position: Clinical Research Associate
Company: Cliantha Research
Location: Ahmedabad, Gujarat, India
Experience Required: 4 – 9 years
Employment Type: Full-Time, Permanent
Key Responsibilities:
- Investigator Management: Identify and qualify potential investigators, ensuring they can fulfill study obligations.
- Documentation Review: Review research protocols, amendments, informed consent documents, case report forms, etc., and suggest modifications.
- Regulatory Support: Assist with regulatory submissions and financial agreements according to local country practices.
- Budget Management: Negotiate study budgets and ensure timely payments to the site.
- Training & Monitoring: Train site teams on the monitoring plan, protocol, and essential document management; perform monitoring visits to ensure compliance.
- Site and Data Management: Ensure proper management of essential documents, source data verification, and trial records.
- Collaboration & Reporting: Collaborate with internal teams to provide status updates to project managers and clients.
- Issue Management: Identify, manage, and escalate site-related issues as needed.
- Close-out & Follow-up: Oversee site close-out and follow-up activities to ensure proper documentation.
- Audit and Quality Assurance: Assist with audits and ensure compliance with ICH-GCP and regulatory guidelines.
Required Qualifications:
- Educational Qualification:
- UG: B.Pharma in any specialization
- PG: M.Pharma, MS/M.Sc in any specialization
Key Skills:
- Clinical Operations
- Site Monitoring
- Clinical Trials
About Cliantha Research:
Cliantha Research is a leading provider of clinical research services in India with expertise in early-phase research, respiratory studies, dermatology, consumer research, and more. The company operates out of Ahmedabad, Noida, and Vadodara.