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Life Sciences Clinical Trials Assistant Job at Samahitha Research
Job Title: Clinical Trials Assistant (CTA)
Company: Samahitha Research
Location: Bengaluru, Karnataka
Experience Required: Minimum 1+ years of experience in Clinical Research
Employment Type: Full-time
Availability: Immediate Joiner Preferred
Job Overview:
Samahitha Research is seeking a dedicated Clinical Trials Assistant (CTA) to support the Clinical Operations team in managing documentation, data flow, and compliance activities for ongoing clinical trials. The CTA will work closely with Clinical Research Associates (CRAs) and the Regulatory and Start-Up (RSU) team to ensure accurate, complete, and audit-ready Trial Master Files (TMFs) in alignment with project timelines and regulatory requirements.
Key Responsibilities for Life Sciences Clinical Trials Assistant Job:
• Assist CRAs and the RSU team in updating, maintaining, and verifying clinical documents and systems (e.g., Trial Master File) to ensure site compliance and performance tracking.
• Support the preparation, distribution, filing, and archiving of clinical trial documentation and reports in accordance with the scope of work and company SOPs.
• Conduct periodic reviews of study files for completeness and accuracy.
• Support CRAs and RSU with the preparation, shipment, and tracking of Clinical Trial Supplies (CTS).
• Track and manage Case Report Forms (CRFs), data queries, and overall clinical data flow.
• Serve as a central contact point for the clinical team, managing communications, correspondence, and related documentation for assigned projects.
• Assist with coordination of investigator meetings, trainings, and other study-related events when required.
• Accompany CRAs on site visits to assist with clinical monitoring duties (after completion of required training).
Qualifications and Skills:
• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related discipline.
• Minimum 1 year of experience in clinical research or a similar administrative role in a CRO or pharmaceutical environment.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Strong written and verbal communication skills in English.
• Excellent organizational, documentation, and time management abilities.
• Knowledge of Good Clinical Practice (GCP), ICH guidelines, and applicable clinical research regulations.
• Ability to collaborate effectively with cross-functional teams and external stakeholders.
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