Job Posting: Clinical Trials Results Analyst, Health Informatics & Technology Solutions, Bethesda, MD
Clinical Trials Results Analyst
Job Number:1300000296
Technology & Management Solutions
Health Informatics & Technology Solutions
Bethesda, MD
Job 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. 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 database Background:
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical research conducted in the United States and around the world. Since September 2008, ClinicalTrials.gov has included a results database of structured summary results information including participant flow, baseline characteristics, outcome measures, and adverse events.
Responsible parties commonly submit results prior to a journal publication. Unlike journal articles that are reviewed by both scientific colleagues and editors, results submitted to ClinicalTrials.gov are not peer reviewed prior to posting, although minimal review criteria must be met.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 submission requirements can be found at ClinicalTrials.gov in the Submit Studies topic area: web address is clinicaltrials.gov/ct2/manage-recs.
Qualifications
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, and/or statisticians) regarding consistency of clinical trial results with review criteria
§ Gain and use a working knowledge of the ClinicalTrials.gov Basic Results Data Element Definitions (http://prsinfo.clinicaltrials.gov/results_definitions.html)
§ Gain and use a working understanding of ClinicalTrials.gov results review criteria (http://prsinfo.clinicaltrials.gov/ResultsDetailedReviewItems.pdf)
§ Create new documentation to help responsible parties submit their clinical trial results records and devise strategies to improve the quality of submissions.
§ Participate in weekly team meetings, often including NLM staff, to discuss process improvement and quality assurance/control of the review process
§ Perform general editorial proofreading
Basic 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 experience in a comparable field plus experience working with clinical trial data will also be considered.
§ 1 year experience with analysis and reporting of clinical trial data
§ 1 year experience with standard mathematical concepts and statistics (correlations, trends, significance, etc.)
§ 1 year experience with standard quantitative measures for health studies
Preferred Skills/Experience:
§ Background knowledge relevant to understanding and interpreting clinical trial data and statistics
§ Ability to identify internal inconsistencies in clinical trial data reporting
§ Strong critical thinking, analysis, and problem-solving skills
§ Ability to critically appraise clinical trial design, methodology and analysis information
§ Experience (via coursework and/or job duties) working with and interpreting the following concepts:
o Mean, median, least square mean, standard deviation, range, inter-quartile range, confidence intervals, etc
o Frequency, incidence, proportion, percentage, rate, etc
o Time-to-event measures
o Parametric and non-parametric statistical tests, interpretation of p-values
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
ICF offers an excellent benefits package, an award winning talent development program, and fosters a highly skilled, energized and empowered workforce.
About ICF International
ICF International (NASDAQ:ICFI) partners with government and commercial clients to deliver professional services and technology solutions in the energy and climate change; environment and infrastructure; health, human services, and social programs; and homeland security and defense markets. The firm combines passion for its work with industry expertise and innovative analytics to produce compelling results throughout the entire program life cycle, from research and analysis through implementation and improvement. Since 1969, ICF has been serving government at all levels, major corporations, and multilateral institutions. More than 5,000 employees serve these clients worldwide. ICF’s Web site is http://www.icfi.com/.
ICF International is an Equal Opportunity and Affirmative Action Employer – M/F/D/V
For a listing of other career opportunities at ICF, please visit our Career Center at www.icfi.com/careers/