Registration Reviewer

Duties & Responsibilities

• Perform quality assurance/quality control (QA/QC) reviews of clinical trial registration submissions for consistency with review criteria
• Gain and use a working knowledge of the ClinicalTrials.gov Protocol Data Element Definitions and ClinicalTrials.gov registration review criteria
• Clearly communicate (via email and record reviews) with “responsible parties” (e.g., clinical trial sponsors, designated principal investigators) regarding the consistency of clinical trial records with review criteria
• Perform general proofreading
• Create new documentation to help responsible parties submit their clinical trial records in accordance with established review criteria
• Post records in accordance with established deadlines
• Monitor data for trends or patterns of problems (e.g., consistent series of errors from a single data provider) and participate in process improvement efforts
• Support database management activities
• Serve as a 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

• Bachelor’s degree from an accredited college in a biomedical science, public health, or related discipline with at least 2 years of professional experience
• Or a master’s degree in a comparable field with no professional experience
• Ability to work within a team environment and contribute to consensus-based decision making
• 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
• General computer skills with a proficiency in MS Word, Outlook, Excel, and PowerPoint

Preferred Qualifications

• Ability to identify and communicate data processing errors and content discrepancies or inconsistencies
• Ability to identify, analyze, and solve problems creatively and independently
• Experience in data management and quality assurance
• General knowledge in the conduct and reporting of clinical trials