Registration Reviewer

Black Canyon Consulting • Bethesda, MD

2d • $65,000 - $70,000

About The Position

Black Canyon Consulting (BCC) is searching for a Clinical Trials Data Quality Analyst to support the ClinicalTrials.gov. Operated by the National Library of Medicine (NLM), a component of the National Institutes of Health (NIH), ClinicalTrials.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. Unlike journal articles that are reviewed by both scientific colleagues and editors, data submitted to ClinicalTrials.gov are not peer-reviewed prior to posting, however specific review criteria must be met.
The successful candidate for this position will be responsible for reviewing results data submissions to ascertain whether they meet minimal review criteria for posting on ClinicalTrials.gov. Information regarding the ClinicalTrials.gov database and reporting requirements can be found at https://clinicaltrials.gov/policy/fdaaa-801-final-rule.

Requirements

• 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
• 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

Nice To Haves

• 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

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 (https://clinicaltrials.gov/policy/protocol-definitions) and ClinicalTrials.gov registration review criteria (https://clinicaltrials.gov/submit-studies/prs-help/protocol-registration-quality-control-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

Benefits

• We attract the best people in the business with our competitive benefits package, including medical, dental, and vision coverage; a 401(k) plan with employer contribution; paid holidays, vacation, and tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level