Clinical Trials Results Analyst
Job description
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 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. 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journal articles that are reviewed by both scientific colleagues and editors, data submitted to ClinicalTrials.gov are not peer-reviewed prior to posting, however specific review criteria must be met.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
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
Basic Qualifications:
  • 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
Preferred Skills/Experience:
  • 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
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
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.
We can only solve the world's toughest challenges by building an inclusive workplace that allows everyone to thrive. We are an equal opportunity employer, committed to hiring regardless of any protected characteristic, such as race, ethnicity, national origin, color, sex, gender identity/expression, sexual orientation, religion, age, disability status, or military/veteran status. Together, our employees are empowered to share their expertise and collaborate with others to achieve personal and professional goals. For more information, please read our
EEO & AA policy
.
COVID-19 Policy: New or prospective U.S. employees must provide proof of complete vaccination on the date of their commencement of employment. If selected for employment, you will provide proof of your full vaccination status, defined as vaccinated two weeks after receiving the requisite number of doses of a COVID-19 vaccine approved or authorized for emergency use by the FDA.
Reasonable Accommodations are available, including, but not limited to, for disabled veterans, individuals with disabilities, and individuals with sincerely held religious beliefs, in all phases of the application and employment process. To request an accommodation please email
icfcareercenter@icf.com
and we will be happy to assist. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodations. Read more about non-discrimination:
EEO is the law
and
Pay Transparency Statement
.

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Company details

Headquarters

9300 Lee Highway, Fairfax, VA 22031

Employee

5001 to 10000

Revenue

$1B to $5B (USD)

Industry

Consulting and Business Services

Company Description
ICF is a global advisory and digital services provider with 8,000 full-and-part-time employees in industries across the public and private sectors. For over 50 years, we’ve been helping clients take on some of the world’s most complex challenges to produce exceptional results. Our work is the catalyst to help shape the future. Beyond our purpose-driven work, we invest in our employees and their experience with us. We have numerous options for healthcare and many additional benefits, including immediate access to 401k retirement matching and pet insurance. Our Employee Community Networks help members find support, belonging, and growth by enhancing internal networks and professional development. We offer paid volunteer time and match your donations. As learning is a never-ending journey, we offer tuition reimbursement, mentorship programs, communities of practice to contribute to and grow from, and memberships to LinkedIn Learning and Coursera. We aim to consider every aspect of how to invest in people so they can belong, grow, and thrive with us.
Company ratings
  • Overall
    3.8
  • Company & Benefits
    3.5 / 5
  • Culture & Values
    3.5 / 5
  • Career Opportunities
    3.1 / 5
  • Work/Life Balance
    3.9 / 5
  • Senior Management
    3.4 / 5
Company reviews
"Work from home is a benefit, Management are unprofessional and need to be trained better"
Current EmployeeInterviewer
Work from home is a benefit, Management are unprofessional and need to be trained better. They will reduce hours towards the end of the month and beginning of the month. You could go from 20-26 hrs a week to 5-7 hours a week if you even get those hours at the end of the month. I wouldnt depend on ICF to pay my bills, get a backup job. Then, they will force you to change your schedule last minute to fit their business needs at any time. Always systems issues and you have to hunt a manager down to make sure your time is edited. Also, they dont show you how to enter sick time if you earn it. you dont even know that youre earning it.
Pros:
Cons:

"Excellent"
Former EmployeeInspector
Excellent, "This employer genuinely cares for your growth, both professionally and personally. "I have been here about a year now, and I have not heard any grumbling about management or the company or even the co-workers. I love it!"
Pros:
Cons:

"Great workplace culture"
Former EmployeeIT Project Manager
- ICF takes ensures the new team members get the education and the guidance to support the projects. - Managers are very supportive - Open communication at all levels

"Ambiente agradável de trabalhar"
Current EmployeeTécnico de Enfermagem
Equipe dinâmica, compromissada. Gestores responsáveis.
Pros:
Cons: