Clinical Study Administrator
2 weeks ago
**Clinical Study Administrator (CSA) Major Medical Technology Company**
- Work with investigative sites toward completion and appropriate submission of all required clinical trial documents prior to site initiation
- Coordinate Institutional Review Board/ Ethics Committee (IRB/EC) submissions and approvals.
- Set-up the Trial Master File and investigator study file binders; manage regulatory document collection
- Review, track, scan and upload regulatory documents to eTMF, and file in TMF
- Review team communications and share pertinent information with clinical trial team members and investigate sites
- Review EDC reports and data listings and discuss findings with CRAs
- Enter and maintain required documentation in study specific databases related to purchases, contracts, health care compliance, and study document management
- Other duties as assigned
**Requirements**:
- You must be an excellent verbal and written communicator, with ability to work with mínimal supervision in a team environment
- Bachelor’s degree or higher and 1-2 years Clinical Trial Coordinator or 3+ years' related experience.
- Proficiency in Microsoft Office products - Word, Excel, PowerPoint, Project, and SharePoint
- Knowledge of FDA guidelines, regulations and/or Good Clinical Practices
Pay: $60,000.00 - $635,000.00 per year
**Benefits**:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Referral program
- Retirement plan
- Vision insurance
Experience level:
- 3 years
Schedule:
- 8 hour shift
**Education**:
- Bachelor's (required)
Work Location: In person
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