Job Summary: The Clinical Trial Assistant (CTA) is responsible for documentation management as part of a clinical trial team, as well as assisting in the appropriate conduct of clinical trials in cooperation with Project Managers (PM), Clinical Research Associates (CRA), and Clinical Trial Specialists (CTS).

Primary Responsibilities
• Maintain Trial Master File (TMF) within a Clinical Trial Management System (CTMS)
• Maintain Investigator Site Files within a Clinical Trial Management System (CTMS)
• Ensure TMF and ISF are always “audit ready”
• Engage in cross-study Quality Control as scheduled
• Ensure timely start-up, study conduct, and closeout in cooperation with the Project Manager

Document Management
• Will maintain the TMF and ISF of multiple clinical trials simultaneously
• Ensures assigned trial files are always “audit ready”
• Secure documentation in cooperation with sites, CRAs, CTSs, PMs, and other stakeholders
• Assist in the management of enrollment of sites, particularly in study start-up
• Assist in the collection and tracking of subject enrollment information
• Update study management reports as necessary

Study Management
• Manage study correspondence, as needed
• Assist PMs in tracking study progress by updating CTMS and other relevant systems
• Assist in developing materials for study training and other stakeholder meetings/presentations

Reporting

· Timely submission of expense and other administrative reports (i.e., time tracking)

Qualifications
• Bachelor’s Degree in the field of biomedical science (i.e., biology, chemistry, microbiology, health/life sciences, biomedical engineering, pharmacology, etc.) preferred
• Ability to enter data and documents with accuracy into CTMS or other relevant systems
• Knowledge of CTMS, EDC, project management software, and other technology-based

programs (including Microsoft software/programs)
• Knowledge of applicable clinical research regulatory requirements (i.e., GCP and ICH Guidelines)
• Effective time management and organizational skills
• Excellent oral and written communication skills
• Mindset of superior customer service for sponsors and sites
• · Location - Mumbaiand securely