Clinical Project Assistant
SanofiÂ
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Job Description
 Location: Thane, India (Hybrid)
Job ID: R1486263
About
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences industry. The company leverages data, technology, and advanced analytics to accelerate the development and commercialization of innovative medical treatments that improve patient outcomes and public health worldwide.
As a Clinical Research Associate (CRA), you will perform monitoring and site management activities to ensure that clinical trials are conducted in compliance with study protocols, regulatory requirements, and sponsor expectations. This position involves close collaboration with study sites, investigators, and cross-functional teams to maintain the quality and integrity of clinical data.
Role & Responsibilities
- Conduct site monitoring visits (selection, initiation, monitoring, and close-out) in compliance with GCP, ICH, and study protocols.
- Support subject recruitment plans at assigned sites to meet project timelines.
- Administer protocol and study-specific training to site staff and maintain consistent communication.
- Evaluate the quality, accuracy, and integrity of site practices to ensure adherence to regulatory and ethical standards.
- Track study progress including submissions, approvals, recruitment, CRF completion, and data query resolution.
- Verify that the Investigator Site File (ISF) and Trial Master File (TMF) are maintained per GCP and local regulations.
- Prepare visit reports, follow-up letters, and documentation for site management and project tracking.
- Collaborate with study team members to support project execution and resolve issues.
- May assist in developing recruitment plans and managing site financial activities as per trial agreements.
Educational Qualification
- Bachelor’s degree in a scientific or healthcare discipline (required).
- Minimum 1 year of on-site clinical monitoring experience.
- Strong understanding of GCP, ICH, and clinical research regulations.
- Solid therapeutic area and protocol knowledge.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint) and familiarity with laptops, iPhones, and iPads.
- Excellent written and verbal communication skills in English.
- Strong organizational, problem-solving, and time management abilities.
- Capability to build and maintain professional relationships with colleagues, clients, and site personnel.
Location
- Thane, India (Hybrid)
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