gov. gov is a registry and results database of publicly and privately supported clinical research conducted in the United States and around the world. Both registration and results submission are accomplished through the web-based Protocol Registration and Results System (PRS).

Responsible parties commonly register trials and submit results prior to a journal publication. gov are not peer-reviewed prior to posting, however specific review criteria must be met. gov.

Requirements

gov/policy/fdaaa-801-final-rule .

Gain and use a working knowledge of the ClinicalTrials.gov Basic Results Data Element Definitions ( https://clinicaltrials.gov/policy/results-definitions ) and ClinicalTrials.gov results review criteria ( https://clinicaltrials.gov/submit-studies/prs-help/results-quality-control-review-criteria ) Create new documentation to help responsible parties submit their clinical trial results records in accordance with established review criteria Devise and help implement strategies to improve the quality of submissions Support database management activities Serve as liaison between data providers (e.g., NIH, industry, universities, and other organizations) and ClinicalTrials.gov Participate in weekly team meetings with NLM staff to discuss process improvement Required skills and experience Master’s degree in biomedical science and/or mathematics-related discipline (epidemiology, biostatistics, neuroscience, biochemistry, etc.) 3+ years’ experience with standard mathematical concepts and statistics (correlations, trends, significance, etc.) 1+ year experience with standard quantitative measures for health studies Ability to work within a team environment and contribute to consensus-based decision making Ability to identify, analyze, and solve problems creatively and independently Ability to handle multiple tasks simultaneously and shift priorities as directed Ability to work efficiently with team members in a fast-paced environment Excellent oral and written communication skills Excellent interpersonal skills and ability to work with people at every level Clearance and Location

Must be able to obtain and maintain a Public Trust clearance Must reside in and be authorized to work in the United States; candidates in the DMV area preferred All work must be performed within the United States

Responsibilities

: Job

Perform quality assurance/quality control (QA/QC) reviews of clinical trial results submissions for consistency with review criteria Clearly communicate (via record reviews, teleconferences, emails, workshops, etc.) with “responsible parties” (e.g., clinical trial sponsors, principal investigators, statisticians) to facilitate understanding of and adherence to submission

Preferred Qualifications

Results Analyst