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Clinical Trials Results Analyst – ICF International

By December 18, 2015Jobs

Position Description: 
The Health Informatics & Technology Solutions (HITS) Division seeks a ClinicalTrials.gov Results Analyst to support our National Institutes of Health/National Library of Medicine (NIH/NLM) client. 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journal articles that are reviewed by both scientific colleagues and editors, data submitted to ClinicalTrials.gov are not peer-reviewed prior to posting, however specific review criteria must be met. Information regarding the ClinicalTrials.gov database and reporting requirements can be found at http://clinicaltrials.gov/ct2/manage-recs/fdaaa

Key Responsibilities:
• 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
• Perform general editorial proofreading

Qualifications:
• PhD (or equivalent degree) from an accredited college in a biomedical science and/or mathematics-related discipline (epidemiology, biostatistics, neuroscience, pharmacology, biochemistry, etc.) OR a Master’s degree and 3 years of post-Masters experience in a comparable field
• Strong critical thinking, analysis, and problem-solving skills
• Experience with standard mathematical concepts and statistics (correlations, trends, significance, etc.)
• Experience with standard quantitative measures for health studies

Preferred Skills/Experience: 
• Background knowledge relevant to understanding and interpreting clinical trial data and statistics
• Experience with analysis and reporting of clinical trial data
• Ability to critically appraise clinical trial design and methodology and to identify internal inconsistencies in clinical trial data reporting
• 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-values Experience (via coursework and/or job duties) working with and interpreting the following concepts:

Professional Skills:
• 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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