Clinical Trial Registration Specialist
3551 Lawrenceville Road Trenton, NJ 08648 US
Target Pay Rate: 30-37.16/hr **salary will be commensurate with experience
The Clinical Trial Registration Specialist will report to the Clinical Trial Registration Lead, prepare and provide operational support for the registration of clinical trials into public registries in US and EU.
- Drives the processes for assigned protocol registration activity, resulting in timely, high-quality information posted on clinical trial registries (Clinicaltrials.gov and EU PAS)
- Liaises with clinical team reviewers (Global Trial Managers, Operations Leads, Statisticians, Clinical Trial Physicians, Clinical Scientists, Development Leads, Patent Attorneys) and other stakeholders on all assigned trials to ensure trial registrations are accurate, consistent with the protocol and reported in adherence to NIH guidelines
- Provides maintenance support to CT Registration Lead for assigned records, to ensure the accuracy of information disclosed on Clinicaltrials.gov
- Submits registration updates to Clinicaltrials.gov on behalf of clinical team, within global regulatory timelines
- Maintains study trackers and ensures they are up to date every week
- Educates stakeholders, as needed, on NIH detailed review criteria for registrations as well as the purpose and format of patient-friendly fields in the protocol registration form
B.S, M.S., or Ph.D...Pharm.D. Please do not submit candidate with a M.D.
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