Expecto Health Science is a leading player in the clinical research and pharmaceutical industry, dedicated to advancing medical research through high-quality clinical trials. With a strong commitment to compliance with ICH-GCP, FDA, and local regulatory standards, we provide a dynamic work environment for professionals passionate about clinical research.
📍 Location: Mumbai, India
📅 Experience Required: 1-3 years in clinical research monitoring
Detailed Job Description
📌 Job Summary
We are seeking proactive Clinical Research Associates (CRA) / Senior CRAs (Sr. CRA) to join our clinical operations team in Mumbai. The role involves monitoring clinical trials, ensuring protocol compliance, and maintaining data integrity in alignment with Good Clinical Practice (GCP).
🎯 Key Responsibilities
1. Site Management
- Conduct site qualification, initiation, monitoring, and close-out visits.
- Ensure protocol, GCP, and regulatory compliance at investigative sites.
- Verify Case Report Forms (CRFs) against source documents.
2. Trial Oversight
- Monitor patient recruitment, informed consent, and protocol adherence.
- Track and resolve data discrepancies and protocol deviations.
- Ensure timely adverse event (AE) reporting.
- Update Clinical Trial Management Systems (CTMS).
3. Documentation & Reporting
- Maintain Trial Master File (TMF) and regulatory documents.
- Prepare monitoring visit reports and follow-up letters.
- Assist in study protocol, ICF, and regulatory submissions.
4. Communication & Collaboration
- Act as the primary contact for assigned sites.
- Coordinate with investigators, site staff, and sponsors.
- Attend investigator meetings and training sessions.
🚀 Why Join Us?
✅ Career Growth: Work on global clinical trials with exposure to FDA & ICH-GCP standards.
✅ Travel Opportunities: 20-50% travel to clinical sites across India.
✅ Learning & Development: Enhance skills in clinical monitoring, regulatory compliance, and data management.
🎓 Eligibility & Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field.
- 1+ years (CRA) / 3+ years (Sr. CRA) in clinical research monitoring.
- Strong knowledge of ICH-GCP, FDA, and local regulations.
- Clinical Research Certification (preferred but not mandatory).
- Excellent communication & problem-solving skills.
💼 Benefits & Perks
✔ Competitive salary + performance incentives
✔ Health insurance & wellness programs
✔ Flexible work policies
✔ Professional development opportunities
📩 How to Apply
Interested candidates can email their CV to:
📧 hr@expectohealthscience.com
📌 Subject Line: “Application for CRA/Sr. CRA Position – [Your Name]”
📍 Location: Mumbai, India
