This role is based on Campus coordinating, collecting & processing documents for clinical trials. It is not a Clinical Site Manager role, and will therefore not travel to the clinical sites nor perform the actual clinical trials.
1. Coordinate collection and processes essential trial documents between investigator sites and Company CDMA, including preparation and/or facilitating IRB/IEC submissions.
2. Ensure accuracy and quality of site documents included in the site initiation packets and throughout the duration of the study.
3. Enter and maintain site information and document tracking in current clinical trial management systems.
4. Ensure trial documentation is well organized, available, current, and archived in a timely manner in the sponsor Trial Master File.
5. Follow applicable work processes, SOPs, communication plans, etc.
6. Ensure timely elevation of issues with sites related to preparation/collection of trial documents, initiation packets, site budget and contracts, or other relevant documentation.
7. May interact with and advise other functions on CTDM responsibilities. Interactions include but are not limited to Global Clinical Side Development, Lead Clinical Site Managers, Clinical Site Managers, etc. 8. May assist with site budget negotiations and contract execution, processing of invoices and payments, and tracking of site study budgets.
Preferred clinical trial experience; Proficient in Microsoft Office to include Word, Excel, PowerPoint; Excellent verbal and written communication skills; Excellent organization skills with exceptional attention to detail; History of working with multiple internal and external customers
Preferred: Bachelor's degree in life sciences (Medical, pharmaceutical, biology, chemistry degree or RN)
Source: Job Diva – Job Listing