Our client, a leading pharmaceutical company, is hiring a Clinical Trial Registration Specialist consultant on a contract basis.
Hybrid – 50% onsite
B.S, M.S., or Ph.D…Pharm.D. Please do not submit candidate with a M.D.
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