Central Clinical Research Coordinator
Central Clinical Research Coordinator
Sanofi
Job description
Looking to begin a career in research and the management of study sites? Explore the Central Clinical Research Associate position at Sanofi in Hyderabad.
Company Description
Sanofi is a healthcare company that offers medicines and health care solutions. The Sanofi Business Operations team in India helps areas such as Speciality Care, Vaccines, General Medicines, CHC, CMO and R&D. The team collaborates with Medical, HEVA and Commercial groups to develop skills and improve business processes.
Job Summary
This position is located in Hyderabad. It requires assisting with research activities for designated registries. The Central Clinical Research Associate serves as the contact for Principal Investigators and site staff aiding in site selection study start-up, monitoring, data quality, safety reporting, documentation and regulatory compliance. The role also involves collaboration with Data Management, vendors, internal teams and other members of the study team throughout the study period.
Key Responsibilities
Assist with site feasibility. Join the site selection process with the registry and clinical project teams.
Help gather and review site documents required for Health Authority, Regulatory Authority, Ethics Committee and Institutional Review Board submissions.
Support site contract activities by collecting documents related to budgets and finalising agreements with sites.
Modify consent forms to meet country requirements. Perform quality checks and track versions as necessary.
Oversee study start‑up documents in the Trial Master File (eTMF).
Verify study information from source documents. Monitor completeness of electronic Case Report Forms. Resolve site questions.
Assist in recruitment activities.
Ensure site facilities and staff comply with protocol and SOP standards.
Provide training to site staff. Help them access systems.
Ensure study sites report safety correctly. Support compliance with all regulations.
Examine study conduct to prepare for audits and inspections review deviations. Assist with root‑cause analysis and CAPA actions when required.
Maintain study trackers, tables, databases and other records.
Support payments to investigators when required.
Educational Qualification
Hold a degree in Pharmacy, a related field or Life Sciences.
Skills Required
Have at least five years of experience in clinical research and development including monitoring clinical trials.
Understand Good Clinical Practice rules.
Possess project management skills that cover time, budget and resources.
Write reports, protocols and regulatory documents.
Have experience working on projects and within a team.
Communicate well in writing and speaking.
Demonstrate ethics and professional honesty.
Salary Structure
The average salary for a Central Clinical Research Associate in India ranges from ₹12 Lakhs to ₹18 Lakhs per year.
Career Development
This position offers professionals the chance to enhance their skills in trial monitoring, data quality, teamwork and global research activities while gaining experience with disease registries and various clinical research projects.
How to Apply
Visit our website. Search for "Central Clinical Research Associate."
Enter your details. Upload your resume.
Submit your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
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