Clinical Trial Registration Specialist

Full Time
Lawrenceville, NJ 08648
Posted
Job description

Hybrid - 50% onsite

Required Education:

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

Job Type: Contract

Salary: $13.00 - $31.72 per hour

Benefits:

  • Health insurance

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

Ability to commute/relocate:

  • Lawrenceville, NJ 08648: Reliably commute or planning to relocate before starting work (Required)

Education:

  • Bachelor's (Preferred)

Experience:

  • Clinical trials: 2 years (Preferred)
  • registration of clinical trials into public registries: 2 years (Preferred)
  • Submits registration updates to Clinicaltrials.gov: 2 years (Preferred)

Work Location: Hybrid remote in Lawrenceville, NJ 08648

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