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Join Our Talent Community - Clinical Support Specialist
Company | Precision Medicine Group |
Address | Chicago, IL, United States |
Employment type | FULL_TIME |
Salary | |
Category | Pharmaceutical Manufacturing |
Expires | 2023-09-21 |
Posted at | 10 months ago |
Job Summary
- May support teams with feasibility and investigator recruitment efforts
- Ownership of eTMF and management of eTMF study mailboxes
- Working with study supply and site binder vendors
- Work within the forecasted submission/approval timelines
- Creating, maintaining and closeout for the most critical client deliverable, TMF
- Providing administrative support to the project team for study related activities such as:
- Informed Consent review
- Providing meeting minutes
- Perform review, validation, tracking and filing of essential documents for investigational sites as well as follow-up on missing/incomplete/invalid documents
- Team training maintenance
- Prepare and submit Central EC applications, support site completion of Local EC applications or other supplemental submissions such as hospital approval submissions, as required
- Planning of site level milestones to allow timely site activation
- CSSs may support the development and mentoring of junior CSSs
- Support or drive site start up activities such as:
- Graduate of a secondary education or equivalent degree
- Minimum of 6 months to 6 years of clinical research experience, depending on level
- Ability to travel domestically and internationally including overnight stays
- Customer service demeanor; demonstrate flexibility, teamwork, and a keen attention to detail
- Ability to speak English proficiently (professional level)
- Experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint)
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