Clinical Trial Assistant (CTA)
Company: IQVIA
Location: Thane, India
Department: Clinical Operations
Job Type: Full-Time
Work Mode: Hybrid
JOB OVERVIEW
The Clinical Trial Assistant (CTA) is responsible for providing administrative and operational support to Clinical Research Associates (CRAs), Regulatory and Start-Up (RSU) teams, and Clinical Operations to ensure the efficient execution of clinical trials. The role involves Trial Master File (TMF) management, clinical documentation, clinical trial supply coordination, Case Report Form (CRF) tracking, study file maintenance, regulatory document management, and coordination of trial-related communications while ensuring compliance with ICH-GCP guidelines and company SOPs.
KEY RESPONSIBILITIES
Clinical Documentation Management
Maintain and update Trial Master File (TMF) documentation.
Prepare, organize, distribute, file, and archive clinical trial documents.
Ensure clinical documentation is complete, accurate, and audit-ready.
Support document version control and tracking.
Perform periodic reviews of study files for completeness.
Clinical Trial Administration
Provide administrative support to Clinical Research Associates (CRAs).
Support Regulatory and Start-Up (RSU) teams with study documentation.
Maintain study records in accordance with SOPs and regulatory requirements.
Assist in maintaining project timelines and documentation.
Coordinate routine administrative activities for assigned studies.
Clinical Trial Supply Management
Assist in the preparation and distribution of clinical trial supplies.
Track shipment and receipt of clinical trial materials.
Maintain supply inventory and tracking logs.
Coordinate clinical supply documentation.
Support study material management activities.
Clinical Data & CRF Management
Track and manage Case Report Forms (CRFs).
Support clinical data flow management.
Assist in tracking data queries and resolutions.
Maintain clinical data tracking systems.
Coordinate documentation related to data management activities.
Trial Coordination & Communication
Act as the central communication point for assigned clinical projects.
Coordinate project correspondence and documentation.
Support communication between CRAs, RSU teams, investigators, and project teams.
Maintain communication logs and project records.
Ensure timely distribution of study-related information.
Clinical Monitoring Support
Assist Clinical Research Associates during study activities.
Accompany CRAs on site visits after required training, when applicable.
Support monitoring visit preparation and follow-up documentation.
Assist with monitoring-related administrative tasks.
Help ensure compliance with study protocols and monitoring procedures.
Compliance & Quality
Ensure compliance with ICH-GCP guidelines and regulatory requirements.
Follow company Standard Operating Procedures (SOPs).
Maintain inspection-ready documentation.
Support quality assurance activities.
Ensure confidentiality and integrity of clinical trial documentation.
EDUCATIONAL QUALIFICATIONS
Required
High School Diploma or equivalent.
Preferred
Bachelor's Degree in:
Life Sciences
Pharmacy
Nursing
Biotechnology
Biological Sciences
Healthcare
Or a related discipline
EXPERIENCE REQUIREMENTS
Required
Minimum 3 years of experience in:
Clinical Trial Administration
Clinical Operations Support
Administrative Support
Clinical Documentation Management
Trial Master File (TMF) Management
Preferred
Experience supporting Clinical Research Associates (CRAs).
Experience with Trial Master File (TMF) systems.
Knowledge of clinical trial documentation processes.
Experience in Clinical Research Organizations (CROs).
Understanding of clinical study workflows.
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Remote, India | Siliguri |Illinois :
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Canada |Quebec :
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Brussels |Antwerp :
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Manila |Croatia :
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