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Clinical Trials Registration Analyst
The Health, Science, and Human Services (HS2) Division seeks a ClinicalTrials.gov Data Quality Analyst to support our National Institutes of Health/National Library of Medicine (NIH/NLM) client. The National Institutes of Health, a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting medical research (http://www.nih.gov/). The NLM collects, organizes, and makes available biomedical science information to scientists, health professionals, and the public (http://www.nlm.nih.gov/).
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journal articles that are reviewed by both scientific colleagues and editors, data submitted to ClinicalTrials.gov are not peer-reviewed prior to posting, however specific review criteria must be met.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 the quality assurance and control of clinical trial registration submissions in accordance with registration review criteria, clear communication with data providers regarding registration submissions, and support of database management activities.
*Information regarding the ClinicalTrials.gov database and reporting requirements can be found at http://clinicaltrials.gov/ct2/manage-recs/fdaaa.
- Perform quality assurance/quality control 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 (http://prsinfo.clinicaltrials.gov/definitions.html) and ClinicalTrials.gov registration review criteria (http://prsinfo.clinicaltrials.gov/ProtocolDetailedReviewItems.pdf)
- Clearly communicate (via email and record reviews) with “responsible parties” (i.e., clinical trial sponsors, designated principal investigators) regarding consistency of clinical trial record 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
- Support database management activities
- Serve as a liaison between data providers (e.g., NIH, industry, universities, and other organizations) and ClinicalTrials.gov
- 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 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
- Ability to work within a team environment and contribute to consensus-based decision making
- Ability to handle multiple tasks simultaneously and shift priority 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
Working at ICF
Working at ICF means applying a passion for meaningful work with intellectual rigor to help solve the leading issues of our day. Smart, compassionate, innovative, committed, ICF employees tackle unprecedented challenges to benefit people, businesses, and governments around the globe. We believe in collaboration, mutual respect, open communication, and opportunity for growth.
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