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Clinical Trial Assistant

2 months ago

mumbai, India Catawba Research India Full time
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