Clinical Research Associate

Clinical Research Associate Vacancy – Auro Labs Madurai

Aurolab hiring Clinical Research Associate in Madurai. M.Pharm, PharmD eligible. Full-time pharma clinical research vacancy.

Aurolab is hiring a Clinical Research Associate at its Madurai facility to support end-to-end clinical research activities for new and existing medical products. This role is designed for candidates with strong grounding in clinical trials, regulatory compliance, and Good Clinical Practice who want hands-on exposure in a globally respected ophthalmic healthcare organization. The position offers direct involvement in clinical studies, ethics committee coordination, investigator management, and post-market surveillance activities that impact real-world patient safety and product quality.

Company Overview

Aurolab is a globally recognized medical device and pharmaceutical manufacturing organization headquartered in Madurai, Tamil Nadu. Established with a mission to make high-quality eye care products affordable and accessible, Aurolab supports healthcare systems across more than 160 countries. The company operates advanced manufacturing facilities compliant with international regulatory standards and plays a critical role in ophthalmic innovation, including intraocular lenses, surgical instruments, pharmaceuticals, and diagnostics.

Aurolab’s clinical research and regulatory ecosystem is built around ethical research, patient safety, and evidence-based product development. The organization maintains strict compliance with ICH-GCP, ISO standards, and applicable national and international regulatory guidelines. Working at Aurolab means contributing to healthcare solutions that directly improve vision outcomes for millions of patients worldwide.

Job Role & Responsibilities

The Clinical Research Associate will be responsible for coordinating, monitoring, and documenting clinical studies for new products in accordance with approved protocols, SOPs, and regulatory requirements. This role demands precision, strong communication skills, and deep understanding of clinical research operations.

Core Responsibilities

• Coordinate and conduct clinical studies for new products in compliance with SOPs, ICH-GCP, and applicable regulatory guidelines
• Set up trial sites and liaise with investigators, doctors, consultants, and study staff to ensure smooth trial execution
• Verify that Ethics Committees operate and function in compliance with GCP, SOPs, and regulatory requirements
• Coordinate with Ethics Committees and prepare documentation for Institutional Review Board approvals
• Support submission, review, and approval processes for clinical study protocols and amendments
• Monitor clinical trials throughout the study duration, including on-site monitoring visits
• Perform source data verification and periodic data review to identify safety signals or protocol deviations
• Ensure accurate and timely documentation of trial activities and corrective actions
• Maintain Trial Master Files at study sites in accordance with regulatory and audit requirements
• Track and manage budgets related to study participant compensation and site payments
• Prepare Clinical Investigation Reports and Clinical Evaluation Reports as per applicable standards
• Review and update Clinical Evaluation Reports for CE marked products
• Support Post Market Surveillance activities including PMS plans, PMCF studies, and Periodic Safety Update Reports
• Ensure continuous compliance with regulatory expectations during audits and inspections

This role plays a direct part in regulatory submissions, product approvals, and lifecycle management, making it critical to Aurolab’s quality and compliance framework.

Eligibility / Qualifications

Educational Background

Candidates must possess a relevant qualification in pharmaceutical, clinical, or life sciences disciplines. Preferred qualifications include:

• M.Pharmacy (Pharmaceutics, Pharmacology, Clinical Pharmacy, Regulatory Affairs)
• Pharm.D
• B.Pharmacy with relevant clinical research experience
• M.Sc in Clinical Research, Life Sciences, Biotechnology, or Pharmacology

Relevant Courses (comma-separated):
B.Pharmacy, M.Pharmacy, Pharm.D, M.Sc Clinical Research, M.Sc Life Sciences, M.Sc Biotechnology, M.Sc Pharmacology

Experience & Skills

• Experience in clinical research, clinical trial monitoring, or regulatory documentation preferred
• Strong understanding of ICH-GCP, ethics committee processes, and clinical trial regulations
• Hands-on experience with clinical trial documentation and monitoring activities
• Ability to communicate effectively with investigators, ethics committees, and internal stakeholders
• Strong attention to detail and documentation accuracy
• Familiarity with post-market surveillance and clinical evaluation reporting is an advantage
• Proficiency in MS Office and clinical documentation tools

Freshers with strong academic exposure and GCP training may also be considered based on interview performance.

Location & Salary

• Job Location: Madurai, Tamil Nadu
• Employment Type: Full-time, On-site
• Salary: Competitive and commensurate with qualifications and experience

Aurolab offers structured career growth, exposure to global regulatory environments, and stable long-term employment in the medical device and pharmaceutical sector.

Application Process

Interested candidates can apply directly through the official job listing using the link below:

https://www.linkedin.com/jobs/view/4359268173/

Applicants are advised to keep updated CVs highlighting clinical research experience, GCP training, and regulatory exposure.

Frequently Asked Questions

Who can apply for this Clinical Research Associate role?

Candidates with M.Pharmacy, Pharm.D, B.Pharmacy, or relevant life science qualifications with clinical research knowledge can apply.

Is this role suitable for freshers?

Yes. Freshers with strong academic background and GCP knowledge may be considered.

What type of clinical studies will I work on?

You will support clinical studies related to ophthalmic medical devices and pharmaceutical products, including post-market studies.

Is this an on-site position?

Yes. This is a full-time, on-site role based in Madurai.

How do I apply?

Apply through the official LinkedIn job link provided in the Application Process section.

Additional SEO Title Options

• Aurolab Clinical Research Associate Hiring – Madurai Pharma Jobs
• Clinical Research Associate Vacancy at Aurolab – PharmD / M.Pharm Eligible
• Aurolab Madurai Hiring for Clinical Research Associate – Healthcare Careers

Summary Table

Company	Aurolab
Vacancies	Clinical Research Associate
Required Education	B.Pharmacy, M.Pharmacy, Pharm.D, M.Sc Clinical Research, Life Sciences
Experience	Fresher to Experienced