Clinical Research Associate (CRA)
Company: Sun Pharmaceutical Industries Limited
Business Unit: Medical Affairs & Clinical Research
Job Title: Clinical Research Associate
Location: Mumbai / Chennai, India
Job Type: Full-time
Experience Required
1–5 years of relevant experience in Clinical Research.
Experience in:
Clinical trial monitoring
Site management
Investigator coordination
Regulatory documentation
GCP compliance
Educational Qualification
Minimum qualification:
Bachelor's Degree or Master's Degree in a healthcare-related field such as:
Pharmacy
Biology
Chemistry
Nursing
Public Health
OR
Postgraduate Diploma in Clinical Research
Preferred Background:
B.Pharm / M.Pharm
Life Sciences
Clinical Research
Healthcare-related disciplines
Department
Medical Affairs & Clinical Research
Job Summary
Sun Pharma is hiring a Clinical Research Associate (CRA) to support clinical trial operations, site management, regulatory activities, and monitoring activities across clinical research centers.
The role involves managing clinical trial sites, ensuring compliance with protocols and Good Clinical Practice (GCP) guidelines, coordinating with investigators, monitoring patient recruitment, reviewing clinical data, and ensuring timely reporting of safety information.
The CRA will work closely with investigators, clinical sites, CRO partners, regulatory teams, and internal clinical research teams to ensure successful execution of clinical studies.
Key Responsibilities
Site Selection & Study Start-Up
Conduct site feasibility assessments.
Identify and evaluate potential investigators and clinical trial sites.
Support investigator selection and site finalization.
Negotiate study budgets with investigators.
Execute:
Confidential Disclosure Agreements (CDA)
Study-related contracts
Prepare and submit regulatory documents for Ethics Committee (EC) approvals.
Clinical Trial Site Management
Ensure timely:
Site initiation visits (SIV)
Site monitoring visits
Site close-out visits (COV)
Prepare and maintain monitoring reports.
Ensure compliance with:
Study protocol
GCP guidelines
Regulatory requirements
Company procedures
Investigational Product (IP) Management
Monitor investigational product dispensing activities.
Ensure inventory tracking and reconciliation.
Verify proper storage and handling of study medication.
Maintain documentation related to IP accountability.
Investigator & Site Training
Train investigators and site staff on:
Clinical trial protocols
Study procedures
GCP principles
Safety reporting requirements
Provide ongoing support to clinical trial teams.
Patient Recruitment & Data Management
Monitor patient recruitment activities.
Ensure timely enrollment of clinical trial participants.
Support:
Source Data Verification (SDV)
Electronic Data Capture (EDC) entry
Query management and resolution
Ensure clinical data quality and completeness.
Safety Reporting & Pharmacovigilance Support
Ensure timely reporting of:
Serious Adverse Events (SAEs)
Suspected Unexpected Serious Adverse Reactions (SUSARs)
Coordinate SAE reporting across:
Investigators
Clinical sites
Internal pharmacovigilance teams
Ensure compliance with Sun Pharma PV policies and regulations.
Risk Management & Quality Compliance
Identify risks affecting clinical trial performance.
Perform risk analysis.
Develop and implement:
Corrective and Preventive Actions (CAPA)
Support sites that do not meet trial expectations.
Clinical Research Coordination
Coordinate with:
Internal clinical research teams
CRO partners
Data management teams
Statistical teams
Support activities related to:
Clinical database management
Statistical analysis
Statistical analysis reports
Database lock (DBL)
Required Skills
Clinical Trial Management
Site Monitoring
Clinical Research Operations
GCP Knowledge
Regulatory Documentation
Ethics Committee Submission
Investigator Management
Clinical Trial Protocol Review
Source Data Verification (SDV)
EDC Systems
Safety Reporting
SAE/SUSAR Management
Risk Management
CAPA Management
CRO Coordination
Stakeholder Communication
Preferred Skills
Experience handling Phase II/III clinical trials.
Knowledge of Indian clinical research regulations.
Experience working with investigators and hospitals.
Understanding of:
Clinical trial lifecycle
Pharmacovigilance processes
Regulatory submissions
Data management activities
Roles and Responsibilities
Manage assigned clinical trial sites.
Ensure studies are conducted according to protocols.
Monitor site performance and compliance.
Maintain accurate trial documentation.
Support regulatory and safety reporting activities.
Coordinate with cross-functional clinical research teams.
Ensure quality and timely completion of clinical studies.
Work Environment
Full-time clinical research role.
Location options:
Mumbai
Chennai
Requires regular interaction with:
Investigators
Hospitals
Clinical trial sites
CRO teams
Field visits to clinical sites may be required.
Estimated Salary Package
The official job posting does not disclose salary details. Based on current Clinical Research Associate salaries in India:
|
Experience |
Estimated Annual CTC |
|---|---|
|
1–2 years |
₹4 – ₹7 LPA |
|
3–5 years |
₹7 – ₹12 LPA |
|
Experienced CRA |
₹10 – ₹15 LPA |
Expected Average CTC: ₹6–10 LPA, depending on clinical trial monitoring experience, therapeutic area exposure, qualifications, and Sun Pharma compensation structure.
Who Should Apply
Ideal candidates:
Bachelor's/Master's degree in Pharmacy, Life Sciences, Nursing, Public Health, or related fields.
1–5 years of clinical research experience.
Knowledge of GCP and clinical trial processes.
Experience with site monitoring and investigator coordination.
Strong documentation and communication skills.
Ability to manage multiple clinical trial activities.
Locations
Chennai, Tamil Nadu, India
Mumbai, Maharashtra, India
Employment Type
Full-time
Clinical Research Operations Role
Key Highlights
Opportunity to work with a leading pharmaceutical company.
Direct involvement in clinical trial execution.
Exposure to site management, regulatory activities, and patient safety.
Experience across clinical research operations.
Career growth opportunities in Medical Affairs and Clinical Research.
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