ICF Consulting Group, Inc. Clinical Trials Information Specialist in Bethesda, Maryland


Health, Environment, Analytics, Resilience & Social Policy Group

Health, Research, Informatics and Technology

Bethesda, MD

Job Description

As a ClinicalTrials.gov Information Specialist you will be responsible for responding to inquiries from data submitters, including researchers from the National Institutes of Health, other federal agencies, industry (pharmaceutical, etc.), non-profit organizations, the general research community and the public. You will also be responsible for identifying improvements and/or updates to technical assistance resource content provided through the ClinicalTrials.gov public and data submission web sites.

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journal articles that are reviewed by both scientific colleagues and editors, data submitted to ClinicalTrials.gov are not peer-reviewed prior to posting, however specific review criteria must be met.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 technical assistance activities and planning and developing communications for the effective dissemination of information about ClinicalTrials.gov, clinical study registration, and results submission.

*Information regarding the ClinicalTrials.gov database and reporting requirements can be found at http://clinicaltrials.gov/ct2/manage-recs/fdaaa

Key Responsibilities

  • Provide technical assistance support via all possible communication channels (e.g., e-mail, telephone, and web) to a broad range of ClinicalTrials.gov stakeholders including the National Institutes of Health (NIH), other federal agencies, industry and non-profit organizations, the general research community, and the public. These responsibilities cover a broad range of topic areas including relevant policies/laws, study record review criteria, technical support with data entry, account management, and/or using the public website.

  • Advise and support the Program Director on new and existing strategies for effectively and routinely providing education and disseminating information about the project s basic objectives.

  • Develop materials describing ClinicalTrials.gov to various audiences, communicate technical, policy, and procedural details about the program to a broad range of audiences in a variety of formats, including conducting trainings and speaking at conferences and events.

  • Develop, prepare, and edit original documents on various aspects of ClinicalTrials.gov for different purposes and audiences including internal documents, reports, outreach campaigns, web pages, newsletter articles and scientific journal publications.

  • Develop and prepare responses to NIH and NLM, as requested, for summaries and updates about ClinicalTrials.gov project activities, such as annual reports.

  • Clearly communicate with data submitters (i.e., clinical trial sponsors, principal investigators) regarding consistency of clinical study records with review criteria


Basic Qualifications

  • Master s degree from an accredited college in a biomedical science, public health or related discipline

  • 2 years of communications/outreach experience, including developing help materials and web-based content

Preferred Skills/Experience

  • Ability to identify, analyze, and solve problems creatively and independently

  • Strong critical thinking, analysis, and problem-solving skills

  • Experience working with Federal health agencies

  • 2 years experience providing technical assistance

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 and also work independently when needed

  • Excellent oral and written communication skills

  • Excellent interpersonal skills and ability to work with people at every level

  • General computer skills (e.g., Microsoft Office), with database experience preferred

ICF offers an excellent benefits package, an award winning talent development program, and fosters a highly skilled, energized and empowered workforce.

ICF is an equal opportunity employer that values diversity at all levels. (EOE Minorities/Females/ Protected Veterans Status/Disability Status/Sexual Orientation/Gender Identity)

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. ICFtogether for tomorrow.

About ICF

ICF (NASDAQ:ICFI) is a global consulting and technology services provider with more than 5,000 professionals focused on making big things possible for our clients. We are business analysts, policy specialists, technologists, researchers, digital strategists, social scientists and creatives. Since 1969, government and commercial clients have worked with ICF to overcome their toughest challenges on issues that matter profoundly to their success. Come engage with us at icf.com at http://www.icf.com/ .

Location: Maryland-Bethesda

Requisition ID: 1800000844