Clinical Study Associate I - Part Time Temp
Behavioral Health Market Context
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Qualifications
- •Demonstrated interest in clinical research and regulatory compliance
- •Strong organizational skills and attention to detail
- •Proficiency in Microsoft Office Suite and experience with clinical databases is beneficial
- •Excellent communication skills and ability to work effectively in a team environment
- •Willingness to travel up to 10% of the time
- •#LI-KN1
- •3 more items(s)
Responsibilities
- •This role is crucial for supporting the execution of clinical studies, ensuring compliance with regulatory requirements, and maintaining the integrity of clinical data
- •The CSA I will work under direct supervision, providing administrative and operational support to clinical study teams
- •Assist in the setup and development of Trial Master Files (TMF) and maintain site regulatory documents
- •Support the coordination and execution of site-specific documents
- •File Management:
- •Ensure accurate filing of site initiation and regulatory documents within the TMF
- •Assist in the entry and management of site information into clinical databases
- •Monitoring Visits:
- •Support preparation for monitoring visits, including internal regulatory file reviews and document preparation
- •Assist with follow-up actions post-monitoring visits as directed by the Clinical Operations Manager
- •Reports & Tracking:
- •Support the preparation of IRB renewal status reports and notify the study team of upcoming renewals
- •Support physician credentialing activities as directed by the Clinical Operations Manager
- •Track and report the shipment and distribution of study-related materials and devices
- •Assist in processing site and patient payments as instructed by the study team
- •Support the reconciliation of payment issues and assist in vendor setup requests
- •Communication & Coordination:
- •Facilitate the distribution of study-specific materials and tools
- •Coordinate internal and external meeting scheduling and logistics
- •This role focuses on self-development and gaining foundational knowledge in clinical research
- •Perform additional duties as assigned for development
- •18 more items(s)
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