Clinical Document Specialist
Greater NYC Area
1 week ago
The Clinical Document Specialist is responsible for supporting Trial Master File (TMF) set-up, maintenance, closure, and transfer for clinical projects at TrialSpark. This role will also act as the superuser and administrator for the eTMF platform that TrialSpark uses. This position reports to the Director, Study Operations and will be expected to perform duties and responsibilities with minimal supervision.
This individual will need to have awareness of applicable clinical research regulatory requirements - ICH GCP, along with familiarity with the documents used in clinical trials at both the TMF and ISF level. You should be able to demonstrate a willingness to work in a fast-paced environment juggling workload with time pressures. The ability to establish and maintain effective working relationships with coworkers, managers, and clients is key and you should have good written and verbal communication skills as well as working knowledge of computer applications such as Word, Excel, and PowerPoint.