Clinical Research Associate

Why This Role Matters

Clinical research plays a critical role in advancing modern medicine and ensuring that new treatments, drugs, and medical technologies are safe and effective for patients. Clinical Research Associates (CRAs) are essential professionals who help manage and monitor clinical trials while ensuring compliance with international regulatory standards.
The Clinical Research Associate (CRA) opportunity at Aithent in Tiruchirapalli is designed for graduates who want to build a professional career in clinical research, clinical trial management, and regulatory-compliant data handling.
This entry-level position provides valuable exposure to clinical trial documentation, site monitoring support, and clinical data management. Fresh graduates with strong analytical skills and an interest in clinical trials can gain hands-on experience working within the structured environment of clinical research organizations (CROs). With the growing demand for skilled professionals in clinical trials and pharmaceutical research, this role offers an excellent starting point for individuals seeking long-term career growth in the healthcare and research sectors.

Job Description

Aithent is currently hiring Clinical Research Associates (CRA) to support its clinical research operations in Tiruchirapalli. The selected candidates will assist in managing clinical trial activities, monitoring study sites, and ensuring accurate documentation in accordance with regulatory guidelines.
The role involves working with clinical trial documentation, assisting senior clinical research professionals, and supporting electronic clinical trial systems. Candidates will also contribute to maintaining regulatory compliance with international clinical research standards such as ICH-GCP Guidelines. This position is ideal for candidates who want to gain practical experience in clinical operations, regulatory documentation, and clinical data management.

Key Features of the Role

•Entry-level opportunity in clinical research operations
•Exposure to clinical trial documentation and site monitoring
•Work with Electronic Data Capture (EDC) systems and clinical databases
•Opportunity to learn regulatory-compliant clinical research processes
•Professional development in the clinical research and pharmaceutical industry

Responsibilities

Clinical Trial Support

•Assist in maintaining clinical trial documentation and regulatory records
•Support site monitoring activities under the supervision of senior CRAs or clinical research managers
•Ensure clinical trial processes comply with study protocols and ICH-GCP guidelines

Clinical Data Management

•Enter and validate clinical trial data using Electronic Data Capture (EDC) systems
•Generate and resolve clinical data queries to maintain high data accuracy
•Support electronic clinical trial data management and database maintenance

Documentation & Reporting

•Prepare clinical study reports, summaries, and trial progress documentation
•Assist in creating clinical data manuals and research documentation tools
•Support User Acceptance Testing (UAT) for clinical research software and applications
•Assist with documentation related to clinical database validation and system testing

Required Qualifications

Educational Requirements

Candidates with the following qualifications are eligible to apply:

•Bachelor of Pharmacy (B.Pharm)
•Master of Pharmacy (M.Pharm)
•B.Tech / B.E in Biotechnology, Biochemistry, or Biomedical Engineering

Experience and Skills

•Strong communication and documentation abilities
•Analytical thinking and attention to detail
•Basic understanding of clinical trials and clinical research processes
•Ability to manage multiple tasks and meet deadlines
•Willingness to learn and work in a fast-paced clinical research environment

Preferred Knowledge Areas

Candidates with basic familiarity in the following areas may have an advantage:
•Clinical trial processes and study management
•ICH-GCP guidelines and regulatory standards
•Electronic Data Capture (EDC) systems
•Clinical data validation and quality checks
•Clinical documentation and regulatory compliance

Salary Insights

Based on similar entry-level Clinical Research Associate positions in India, the expected salary range is approximately:
₹3,00,000 – ₹5,00,000 per year.
Actual compensation may vary depending on the candidate’s skills, interview performance, and company policies.

Company Overview

Aithent is a technology and services organization that provides specialized solutions in areas such as healthcare, clinical research support, and enterprise technology services. The company works with global organizations to deliver innovative and regulatory-compliant solutions. Through its clinical research operations, Aithent supports pharmaceutical and healthcare companies in managing clinical trials, handling research data, and maintaining high standards of regulatory compliance. The organization focuses on building skilled teams capable of supporting complex clinical research processes while maintaining data integrity and operational efficiency.

FAQs

Who can apply for the CRA role at Aithent?
Candidates with B.Pharm, M.Pharm, or Biotechnology-related engineering degrees are eligible.

Is this role suitable for fresh graduates?
Yes. This is an entry-level position, and fresh graduates are encouraged to apply.

What type of work will a CRA perform?
The role includes clinical trial support, site monitoring assistance, clinical data management, and documentation.

What systems will candidates work with?
Candidates may work with Electronic Data Capture (EDC) systems and clinical trial databases.

What career opportunities can follow this role?
Experience as a CRA can lead to career growth in clinical operations, regulatory affairs, clinical data management, and pharmaceutical research.

Application Tips

•Highlight your pharmacy or biotechnology qualification clearly in your resume
•Mention any knowledge of clinical research, clinical trials, or GCP guidelines
•Include internships or academic projects related to clinical research or biotechnology
•Emphasize analytical skills, communication abilities, and documentation experience
•Show your willingness to learn and work in a clinical research organization (CRO) environment