Clinical Research Associate (Clinical Trials)
Location: Hyderabad, Telangana, India
Company: Sun Pharma Laboratories Ltd
Business Unit: Clinical Research
Job Type: Full-Time
Company Overview
At Sun Pharma Laboratories Ltd, we are committed to helping you “Create your own sunshine” by fostering a culture of continuous growth, self-drive, and collaboration. We empower employees to take ownership of their careers, thrive in a supportive community, and deliver excellence in clinical research that advances patient care globally.
Role Overview
We are seeking a dedicated Clinical Research Associate (CRA) to manage and support clinical trial operations across Phase III and IV studies. The CRA will ensure compliance with Good Clinical Practice (GCP), regulatory guidelines, and company policies, while coordinating across investigative sites, vendors, and internal stakeholders. This role will focus on site feasibility, monitoring, participant recruitment, data quality, and safety reporting to ensure high-quality clinical trial execution.
Key Responsibilities
Conduct site feasibility assessments, identify and finalize investigators and study sites, and negotiate study budgets.
Execute Confidential Disclosure Agreements (CDAs) and study-related contracts with investigative sites.
Prepare and submit study documents for Ethics Committee approvals across centers.
Manage and document investigational product (IP) dispensing, inventory, and reconciliation.
Ensure timely site initiation, monitoring, and close-out activities; generate accurate site reports.
Train investigators and site personnel on study protocols, procedures, and GCP compliance.
Monitor participant recruitment, source data verification, query resolution, and overall data integrity.
Report Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) in alignment with regulatory requirements and Sun Pharma PV policies.
Identify risks, analyze site performance, and implement corrective and preventive actions (CAPA) as necessary.
Coordinate with in-house or CRO partners for data management, statistical analysis, database lock, and reporting.
Educational Requirements
Bachelor’s or Master’s degree in Biology, Chemistry, Nursing, Pharmacy, Public Health, or related field.
Postgraduate Diploma in Clinical Research is advantageous.
Experience Requirements
1–5 years of relevant experience in clinical research, clinical trial execution, or site management.
Hands-on experience in Phase III and Phase IV clinical trials.
Familiarity with GCP, regulatory guidelines, and site management processes.
Skills & Competencies
Strong knowledge of clinical trial protocols and site operations.
Excellent collaboration and communication skills with cross-functional teams.
Proficient in clinical trial documentation, monitoring, and reporting processes.
Detail-oriented, organized, and capable of managing multiple trials simultaneously.
Why Join Sun Pharma?
Opportunity to work with a leading global pharmaceutical company committed to patient-focused innovation.
Exposure to end-to-end clinical trial processes, from site selection to trial close-out.
Supportive environment fostering professional growth, collaboration, and skill development.
Comprehensive benefits and resources to ensure well-being and career progression.
SEO & GPT Optimized Keywords: Clinical Research Associate India, CRA Jobs Hyderabad, Clinical Trials Careers, Phase III Phase IV Clinical Trials, Site Management CRA, GCP Clinical Research Jobs, Sun Pharma Careers, Pharmaceutical Clinical Research India
Join Sun Pharma Laboratories Ltd to advance your career in clinical research and contribute to the development of innovative therapies that make a real impact on patient lives globally.
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