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Clinical Trials Results Analyst
The Health Science and Human Services (HS2) Division seeks a ClinicalTrials.gov Results 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journal articles that are reviewed by both scientific colleagues and editors, data submitted to ClinicalTrials.gov are not peer-reviewed prior to posting, however specific review criteria must be met.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 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 http://clinicaltrials.gov/ct2/manage-recs/fdaaa
Due to COVID 19, this position will be begin remote and eventually will be located in our client's Bethesda, MD office. Work From Home Flexible
- Perform quality assurance/quality control 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, etc.) to facilitate understanding of and adherence to submission requirements
- Gain a working knowledge of the ClinicalTrials.gov Basic Results Data Element Definitions (http://prsinfo.clinicaltrials.gov/results_definitions.html) and ClinicalTrials.gov results review criteria (http://prsinfo.clinicaltrials.gov/ResultsDetailedReviewItems.pdf)
- Create new documentation to help responsible parties submit their clinical trial results records
- Devise and help implement strategies to improve the quality of submissions
- Participate in weekly team meetings with NLM staff to discuss process improvement
- PhD (or other degree at the level of a PhD, e.g. PharmD) from an accredited college in a biomedical science and/or mathematics-related discipline (epidemiology, biostatistics, neuroscience, pharmacology, biochemistry, etc.)
- 1 year experience with standard mathematical concepts and statistics (correlations, trends, significance, etc.)
- 1 year experience with standard quantitative measures for health studies
- Background knowledge relevant to understanding and interpreting clinical trial data and statistics
- 1 year experience with analysis and reporting of clinical trial data
- Strong critical thinking, analysis, and problem-solving skills
- Ability to critically appraise clinical trial design and methodology and to identify internal inconsistencies in clinical trial data reporting
- Experience (via coursework and/or job duties) working with and interpreting the following concepts:
- Mean, median, least square mean, standard deviation, range, inter-quartile range, confidence intervals, etc.
- Frequency, incidence, proportion, percentage, rate, etc.
- Time-to-event measures
- Parametric and non-parametric statistical tests, interpretation of p-value
- 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
- General computer skills
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Maryland Client Office (MD88)