Clinical Trial Disclosure Specialist

About the engagement

KARAMATA is engaging an independent contractor to prepare and maintain ClinicalTrials.gov records for client studies, from initial registration through results reporting. The work covers drafting and updating records in the Protocol Registration and Results System (PRS), checking entries against approved source documents, resolving quality-control comments, and tracking required updates and deadlines.

You'll coordinate with each client's clinical operations, regulatory, statistics, and medical writing teams to collect approved content and resolve discrepancies. The client's Responsible Party keeps final release and certification authority.

Scope of work

• Prepare ClinicalTrials.gov registrations, updates, and results submissions for client studies

• Draft and update PRS records from approved source documents

• Prepare participant-flow, baseline, outcome, and adverse-event results modules

• Review records for accuracy and resolve PRS quality-control comments

• Flag upcoming disclosure deadlines and missing or conflicting information

• Deliver audit-ready submission documentation for each study

What you bring

• Two or more years of hands-on work in clinical trial registration, results reporting, regulatory disclosure, or a closely related function

• Experience creating and maintaining ClinicalTrials.gov records in PRS; results-reporting experience is a plus

• Working knowledge of FDAAA 801, the Clinical Trials Registration and Results Information Submission Final Rule, and applicable NIH disclosure requirements

• Ability to read and compare protocols, amendments, statistical analysis plans, clinical study reports, and results tables

• Written English precise enough for public registry content and formal quality review

• Ability to manage several records, deadlines, review cycles, and document versions at once

• Ability to trace discrepancies to their source and explain what's needed to resolve them

• Clear, professional communication with clients and study teams

• Proficiency with ClinicalTrials.gov PRS, Microsoft Word, Microsoft Excel, and document-management systems

• A degree in life sciences, clinical research, regulatory affairs, public health, or a related field is welcome; equivalent experience counts

Rate and terms

• Independent contractor (1099) at $35–$45 per hour

• Fully remote in the US. Not open to residents of California, Connecticut, Illinois, Massachusetts, New Jersey, or Vermont.

• No travel