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Clinical Research Informatics Subject Matter Expert

CTIS Rockville, MD

  • Posted: over a month ago
  • Full-Time
Job Description

For more than 25 years CTIS Inc. has been a leader in developing innovative informatics solutions for the health industry across the areas of communication, research, care, education and public health. CTIS offers applied solutions for government organizations, health systems, academic medical institutes, physicians, payers, and patients. Based in Rockville, MD, CTIS is expanding and looking for talented and creative professionals to join our growing organization. 


We are currently seeking a Clinical Research Informatics Subject Matter Expert with a Bachelor’s of Science or higher in nursing, pharmacy, data analytics/informatics or health information systems and at least five years’ experience working in clinical research or the healthcare industry. The ideal candidate will have experience as a nurse, research pharmacist, Clinical Research Associate (CRA), Clinical Research Coordinator (CRC) or Clinical Operations manager working with clinical research applications/informatic systems, providing clinical trial expertise to cross functional development teams and applicable knowledge of FDA/EMA regulations, GCP/ICH guidelines, and related policies. 

Primary Responsibilities


  • Review and analyze clinical trial data management systems to identify areas of integration and enhancements 
  • Help optimize workflows and clinical information systems with innovative technologies that serve new business purposes and improve existing processes
  • Provide leadership and clinical expertise to help drive the development of quality enterprise systems and features that provide the greatest business value
  • Support program analyses and impact assessments to assist in identifying gaps and areas of opportunity for improvement
  • Apply knowledge of clinical analytics to drive operational efficiencies and effectiveness
  • Apply understanding of clinical metrics to various data sets, map and group data to support implementation of clinical solutions based on advanced analytics
  • Provide clinical governance and validation on data analytics solutions to include contributing to data analysis, report generation, and white papers
  • Provide program support including development of standard operating procedures, data analysis and stakeholder presentations
  • Provide project management support including meeting facilitation, taking meeting notes, action item follow up, and communication with NCI stakeholders, application users and internal agile teams
  • Interface with stakeholders and agile teams during elicitation sessions and requirement review meetings to provide direction for the project
  • Leveraging clinical knowledge and experience to present requirement findings and product demonstrations to agile teams and stakeholders 
  • Conduct peer reviews of business interaction processes, workflows, use cases and storyboards that are used as inputs for modeling current "as-is" state of the business/project 
  • Collaborate with agile teams on User Interface (UI) design, online help documentation and development of training materials 
  • Assist with product validation and user acceptance testing to ensure that the desired state has been reached per stakeholder requirements and expectations
  • Assist with post-production support such as product training and help desk operations

Technical Skills/Knowledge: 

  • Proficient with clinical research life cycle, processes and data management applications
  • Understanding of Software development methodologies i.e. Agile/SCRUM, SAFe
  • Proficient with Microsoft Office products

Non-technical skills: 

  • Excellent written and verbal communication skills
  • Excellent presentation skills
  • Problem solving and critical thinking skills 
  • Ability to work independently and within a team to achieve results

Required Education & Experience:

  • Bachelor’s degree or higher in life sciences, healthcare or IT (or equivalent qualification)
  • 5 - 7 years’ experience as a Research Nurse, Clinical Research Associate, Coordinator or Operations Manager OR
  • 3-5 years project management or business analyst experience in clinical research or healthcare informatics industry a plus

Preferred Skills: 

  • Understanding of GCP, 21 CFR 11, ICH and other clinical research regulations/standards
  • Professional Certifications i.e. CRA, CCRP, CRC, CCBA®, CBAP® , PMP 
  • Experience using collaboration technologies (e.g. WebEx, MS Teams, SharePoint, etc.)
  • Familiarity with using Atlassian tools e.g. Jira and Confluence



Rockville, MD
20850 USA



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