Clinical Research Associate

Why This Role Matters
Clinical trials are essential for ensuring the safety, efficacy, and quality of new medicines before they reach patients. The Clinical Research Associate (CRA) plays a critical role in managing clinical trial activities, maintaining regulatory compliance, and ensuring that clinical studies are conducted according to approved protocols and Good Clinical Practice (GCP) guidelines. At Sun Pharma, this role contributes directly to the development of innovative pharmaceutical products that improve patient outcomes globally. By monitoring study sites, coordinating with investigators, and ensuring accurate clinical data collection, the CRA helps maintain the integrity of clinical trials and supports the successful approval of life-saving medicines.

Job Description
The Clinical Research Associate will support and manage clinical trial operations across assigned study sites. The role involves coordinating with investigators, overseeing study activities, ensuring compliance with regulatory requirements, and maintaining high standards of clinical research documentation. The CRA will also monitor study progress, verify clinical data accuracy, and ensure adherence to the study protocol and ethical guidelines.

Key Features of the Role:
• Active involvement in clinical trial site feasibility, initiation, monitoring, and close-out activities
• Hands-on exposure to Phase III and Phase IV clinical trials
• Opportunity to work with investigators, ethics committees, and cross-functional teams
• Engagement in regulatory documentation, safety reporting, and clinical data verification
• Participation in risk assessment and quality assurance activities for clinical sites

Responsibilities
• Conduct site feasibility assessments and identify potential investigators for clinical studies
• Negotiate study budgets with investigators and finalize study sites and investigators
• Execute confidentiality disclosure agreements (CDA) and study-related contracts
• Prepare and submit clinical study documents for Ethics Committee (EC) approval across study centers
• Oversee investigational product (IP) dispensing, inventory management, and reconciliation
• Ensure timely completion of site initiation, site monitoring, and site close-out visits
• Train investigators and site personnel on study protocols, procedures, and GCP guidelines
• Monitor patient recruitment and ensure accurate and timely data entry into clinical databases
• Perform source data verification and resolve clinical data queries
• Ensure timely reporting of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) according to regulatory requirements
• Communicate safety updates and regulatory requirements to investigators and study teams
• Identify potential risks at clinical sites and implement corrective and preventive actions (CAPA)
• Coordinate with internal teams or contract research organizations (CROs) for data management, statistical analysis, and database lock (DBL) activities

Required Qualifications
• Bachelor’s or Master’s degree in a health or science-related field

Educational Requirements:
• Degree in Biology, Chemistry, Nursing, Pharmacy, Public Health, or a related discipline
• Postgraduate Diploma in Clinical Research is an added advantage

Experience and Skills:
• Minimum 1–5 years of experience in clinical research or clinical trial management
• Strong understanding of Good Clinical Practice (GCP) and clinical trial regulatory guidelines
• Knowledge of Phase III and Phase IV clinical trial processes
• Experience in site management and monitoring activities
• Ability to collaborate with investigators, regulatory authorities, and cross-functional teams
• Strong analytical, documentation, and problem-solving skills
• Effective communication and stakeholder management abilities

Salary Insights:
• Salary is not specified in the notification and will depend on experience, qualifications, and company policies

Company Overview
Sun Pharma is one of the largest pharmaceutical companies globally and a leading specialty generics manufacturer. The company is committed to innovation, research, and improving patient lives through high-quality medicines. With operations in numerous countries, Sun Pharma focuses on developing safe and effective pharmaceutical products while maintaining strong regulatory compliance and ethical research practices. The organization encourages professional growth, continuous learning, and collaboration, creating an environment where employees can build rewarding careers in the pharmaceutical and clinical research industry.

FAQs
• What is the job location?
Hyderabad

• Which department is offering this role?
Clinical Research Business Unit

• What is the required experience?
Minimum 1–5 years in clinical research

• What qualifications are required?
Degree in a health or science-related field such as Pharmacy, Biology, Nursing, or Public Health

• What type of clinical trials will the candidate work on?
Primarily Phase III and Phase IV clinical trials

Application Tips
• Highlight clinical trial monitoring experience and knowledge of GCP guidelines in your resume
• Include experience related to site management, regulatory submissions, and safety reporting
• Mention exposure to clinical trial phases, especially Phase III or Phase IV studies
• Demonstrate your ability to collaborate with investigators and cross-functional teams
• Ensure your resume clearly reflects experience with clinical documentation, monitoring reports, and regulatory compliance