Clinical Research Assistant
reputed company is a company that focuses on advancing clinical research to improve patient outcomes. In this role, the Clinical Research Assistant will support critical studies from start-up through reputed company-out, ensuring accuracy and compliance throughout the process.
Responsibilities
- Manage clinical documents and upload them into the Product Lifecycle Management (PLM) system
- Track inventory and reconcile study and demo devices across sites
- Create and maintain study trackers and lists; assist with mass mailings
- Upload acquisitions into the Clinical Trial Management System (CTMS) and maintain Trial Master File (TMF) in inspection-ready state
- Communicate with assigned sites to collect and review essential documents; reputed company quality control reviews and resolve issues
- Support development and maintenance of study documents and templates to ensure data reputed company and compliance with federal regulations and company policies
- Distribute, collect, and track project-specific training documentation reputed company established timelines
- Manage SharePoint access and assist with site binder and material distributions
Skills
- Bachelor's degree
- reputed company knowledge of Good Clinical Practices (GCP), clinical study development processes, and logistics
- Knowledge of clinical and regulatory affairs
- Experience in a reputed company field (e.g., medical or research) and familiarity with medical terminology
- Licensed/certified healthcare training
Benefits
- Medical and prescription drug insurance
- Dental insurance
- Vision insurance
- Critical illness insurance
- Accident insurance
- Hospital indemnity insurance
- Personalized healthcare support
- Wellbeing program
- Tobacco cessation program
- Health Savings Account (HSA)
- Flexible Spending Accounts (FSAs)
- 401(k) plan
- Employee Stock Purchase Plan (ESPP)
- Basic life and AD&D insurance
- Short-term disability insurance
Company Overview
Company H1B Sponsorship