Aurolab, a leading medical device manufacturing organization based in Madurai, Tamil Nadu, is hiring a Clinical Research Associate (CRA) for its on-site clinical research operations. This role is ideal for professionals with hands-on experience in clinical trials, ethics committee coordination, GCP compliance, and post-market surveillance. Candidates seeking a stable, full-time opportunity in medical device clinical research will find this position highly rewarding.
This Clinical Research Associate job in Madurai offers direct exposure to clinical investigations, clinical evaluation reports (CER), PMS, and PMCF activities, making it an excellent career move for life sciences and pharmacy professionals.
Key Responsibilities – Clinical Research Associate
As a Clinical Research Associate at Aurolab, you will be responsible for:
- Coordinating and conducting clinical studies for new products in compliance with SOPs, ICH-GCP, and regulatory guidelines
- Setting up trial sites and liaising with investigators, doctors, and consultants
- Coordinating with Ethics Committees (IRB/IEC) and preparing submission dossiers
- Verifying Ethics Committee compliance with GCP and regulatory requirements
- Monitoring clinical trials, including on-site monitoring visits
- Performing Source Data Verification (SDV) and safety reviews
- Maintaining and updating the Trial Master File (TMF) at study sites
- Managing study budgets and participant compensation
- Preparing Clinical Investigation Reports (CIR) and Clinical Evaluation Reports (CER) for CE-marked products
- Supporting Post Market Surveillance (PMS), Post Market Clinical Follow-up (PMCF), and Periodic Safety Update Reports (PSUR)
Qualifications & Eligibility
To be considered for this Clinical Research Associate role, candidates should have:
- A degree in Pharmacy, Life Sciences, Clinical Research, or a related discipline
- Practical knowledge of clinical trials and medical device regulations
- Familiarity with ICH-GCP, ISO 14155, and ethics committee processes
- Experience in TMF management, monitoring, and clinical documentation
- Strong communication, documentation, and coordination skills
- Willingness to work on-site in Madurai, Tamil Nadu
Candidates with prior experience in medical device clinical research will be preferred.
Salary & Benefits
- Salary Range: ₹4,50,000 – ₹7,00,000 per annum (indicative, based on experience)
- Full-time, permanent employment
- Opportunity to work with a reputed ophthalmic medical device organization
- Hands-on exposure to end-to-end clinical research lifecycle
- Career growth in regulatory-compliant clinical research operations
How to Apply
Kindly connect with us at: talent@aurolab.com
