About the job
At Black Canyon Consulting (BCC), we are on the lookout for a meticulous Clinical Trials Data Quality Analyst to bolster our efforts in supporting ClinicalTrials.gov. This invaluable resource, managed by the National Library of Medicine (NLM) under the National Institutes of Health (NIH), serves as a comprehensive registry and results database for clinical research conducted domestically and globally. While the registration and results submission occurs via the web-based Protocol Registration and Results System (PRS), it is crucial to note that data submitted to ClinicalTrials.gov does not undergo peer review before publication, although it must adhere to specific review criteria.
The ideal candidate will be tasked with reviewing results data submissions to determine their compliance with minimum review standards for publication on ClinicalTrials.gov. Additional information about the ClinicalTrials.gov database and its reporting requirements can be found at this link.
Duties & Responsibilities:
Job Responsibilities
- Conduct quality assurance and quality control (QA/QC) assessments of clinical trial result submissions to ensure alignment with review criteria.
- Engage in effective communication (via record reviews, teleconferences, emails, workshops, etc.) with responsible parties (such as clinical trial sponsors, principal investigators, and statisticians) to enhance understanding of and compliance with submission requirements.
- Develop a comprehensive understanding of the ClinicalTrials.gov Basic Results Data Element Definitions and results review criteria.
- Produce documentation to assist responsible parties in navigating submission protocols.
