Are you an experienced Clinical Research Associate (CRA) looking for your next career opportunity in the pharmaceutical industry? Here’s an excellent opportunity to join Macleods Pharmaceuticals, one of India’s leading pharmaceutical companies, as a Clinical Research Associate (CRA) at its R&D III Centre in Mumbai.
If you have 3 or more years of clinical research monitoring experience and possess strong knowledge of ICH-GCP guidelines, site management, and clinical trial operations, this could be your chance to work on innovative clinical studies and contribute to drug development in a professional research environment.
📌 Job Overview
| Particular | Details |
|---|---|
| Company | Macleods Pharmaceuticals Ltd. |
| Job Role | Clinical Research Associate (CRA) |
| Department | Clinical Trials – R&D III Centre |
| Location | Mumbai, Maharashtra |
| Job Type | Full-Time |
| Work Mode | Work From Office (WFO) |
| Experience Required | Minimum 3 Years |
| Eligible Candidates | Experienced Clinical Research Professionals |
| Application Mode | Email Resume |
🏢 About Macleods Pharmaceuticals
Macleods Pharmaceuticals is among India’s fastest-growing pharmaceutical companies with a strong presence in domestic and international markets. The company is known for developing high-quality medicines across various therapeutic segments while maintaining global regulatory standards.
Its Clinical Trials department plays a significant role in conducting ethical, high-quality clinical research to support innovative drug development. Working here provides professionals with exposure to advanced research methodologies, regulatory compliance, and multidisciplinary clinical teams.
💼 Key Responsibilities
As a Clinical Research Associate, you will be responsible for managing clinical trial activities from site initiation through study completion while ensuring compliance with regulatory guidelines.
🔹 Site Selection & Feasibility
- Conduct Site Selection Visits (SSVs)
- Evaluate investigator capabilities
- Assess infrastructure and patient availability
- Prepare feasibility reports
- Recommend suitable clinical sites
🔹 Ethics Committee Documentation
- Prepare ethics committee submission packages
- Coordinate Institutional Ethics Committee (IEC) approvals
- Review regulatory documents
- Maintain essential study files
- Ensure documentation compliance
🔹 Site Initiation
- Conduct Site Initiation Visits (SIV)
- Train investigators and site staff
- Explain study protocol
- Review informed consent procedures
- Verify study readiness before patient recruitment
🔹 Site Monitoring
Regular monitoring activities include:
- Performing Site Monitoring Visits (SMVs)
- Source Data Verification (SDV)
- Reviewing Case Report Forms (CRFs)
- Monitoring patient safety
- Ensuring protocol compliance
- Tracking recruitment progress
- Resolving data queries
- Following Good Clinical Practice (GCP)
🔹 Safety Reporting
The CRA will ensure proper reporting of:
- Adverse Events (AE)
- Serious Adverse Events (SAE)
- Protocol deviations
- Safety documentation
- Regulatory timelines
🔹 Investigational Product Management
Responsibilities include:
- Drug accountability
- Storage verification
- Temperature log review
- Drug reconciliation
- Inventory management
- Clinical supply tracking
🔹 Site Communication
The CRA acts as the primary communication point between:
- Investigators
- Study Coordinators
- Clinical Trial Managers
- Regulatory Teams
- Data Management Teams
- Sponsor Representatives
🔹 Documentation & Quality
- Maintain Trial Master File (TMF)
- Update monitoring reports
- Ensure SOP compliance
- Support internal audits
- Prepare inspection-ready documentation
🎓 Eligibility Criteria
Candidates should possess:
- Bachelor’s or Master’s degree in:
- B.Pharm
- M.Pharm
- Pharm.D
- B.Sc Life Sciences
- M.Sc Life Sciences
- Nursing
- Clinical Research
- Allied Healthcare
💼 Experience Required
Applicants must have:
- Minimum 3 years of Clinical Research Associate experience
- Experience in clinical trial monitoring
- Site management expertise
- Knowledge of ICH-GCP
- Experience handling multicentre clinical studies
- Good documentation practices
Freshers are not eligible for this position.
⭐ Required Skills
Successful candidates should possess:
- Excellent communication skills
- Clinical trial monitoring experience
- Source Data Verification (SDV)
- Clinical Trial Management System (CTMS)
- Electronic Data Capture (EDC)
- Good Clinical Practice (GCP)
- Regulatory documentation
- Time management
- Analytical thinking
- Microsoft Office proficiency
📈 Why Join Macleods Pharmaceuticals?
Working with Macleods offers several professional benefits:
- Opportunity to work on large-scale clinical trials
- Exposure to global regulatory standards
- Career growth in Clinical Research
- Professional learning environment
- Experienced clinical research teams
- Modern R&D infrastructure
- Stable pharmaceutical organization
- Competitive salary package
- Long-term career opportunities
📩 How to Apply
Interested and eligible candidates can apply by sending their updated resume through email.
Email Subject Format
Application for Clinical Research Associate – Mumbai – Your Name – 3+ Years Experience
Send Your Resume To
🌟 Tips Before Applying
Before submitting your application, ensure your resume includes:
- Clinical trial monitoring experience
- Number of Site Selection Visits conducted
- Site Initiation Visits experience
- Site Monitoring Visits handled
- Therapeutic area exposure
- Regulatory knowledge
- ICH-GCP certification (if available)
- Clinical software expertise
- Professional achievements
- Updated contact information
Frequently Asked Questions (FAQs)
1. Is this job open for freshers?
No. The company is specifically looking for candidates with at least 3 years of Clinical Research Associate experience.
2. Where is the job location?
The position is based at the R&D III Centre in Mumbai, Maharashtra.
3. Is this a Work From Home job?
No. This is a Work From Office (WFO) position.
4. What qualifications are preferred?
Candidates with qualifications in Pharmacy, Life Sciences, Clinical Research, Nursing, or allied healthcare disciplines are preferred.
5. What is the main responsibility of a CRA?
A Clinical Research Associate monitors clinical trial sites, ensures protocol compliance, verifies clinical data, supports regulatory requirements, and helps maintain participant safety throughout the study.
Final Thoughts
If you are an experienced Clinical Research Associate seeking an opportunity to work with a reputed pharmaceutical company, this opening at Macleods Pharmaceuticals could be an excellent step forward in your career. The role offers the chance to work on diverse clinical trials, collaborate with experienced professionals, and contribute to the development of quality healthcare solutions.
Candidates meeting the experience requirements are encouraged to apply early by sending their updated resume to the official recruitment email. Ensure that your application clearly highlights your monitoring experience, regulatory expertise, and clinical trial accomplishments to improve your chances of selection.
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