Clinical Research Informaticist, Sr.
Clinical Research Informatics
Duke Clinical Research Institute
The Clinical Research Informaticist, Sr. position is a leadership role on significantly large and/or complex (often novel) clinical research projects. This includes the development, use and evaluation of standards, models, processes and systems to optimize the design and conduct of clinical and translational research This is often accomplished through modeling workflow, semantic relationships, terminology, business rules and specification of technology requirements utilized in research. The Informaticist, Sr. has an understanding of the broader biomedical informatics practices including medical computing, terminology and healthcare processes. Expert knowledge and routine contribution to the domain of clinical research informatics is expected. The Informaticist Sr. is an active leader alongside faculty ensuring the success of clinical and translational research projects. Close collaboration with other disciplines and departments within and across Duke and external organizations is necessary.
The Informaticist, Sr. is typically the senior informatics leader on one or more large complex biomedical research projects and serves in preceptor capacity for other informatics staff
Travel is required.
The Clinical Research Informaticist supports and contributes to the administrative processes for the Informatics group and overall department.
The Informaticist Sr. contributes to the project management activities of assigned projects and holds responsibility and accountability for assigned work contributing to the success of the project.
Independently define work requirements for new projects and monitor scope of assigned work within an ongoing project. This includes working with internal and external collaborators. Analyze and resolve issues that have potential to jeopardize agreed upon deliverables.
Engage and collaborate with stakeholders in the development of artifacts defining the workflow and technical specifications in support of significantly complex and/or novel clinical or translational research projects.
Evaluate costs, risks, benefits and regulatory requirements of implementation options considered by project teams. Communicate to project teams and CRI leadership as appropriate.
Independently prepare project budgets in conjunction with Business Development and/or CRI Project Leader. Monitor budget expenditure actuals against original projections. Escalate to CRI leadership as appropriate.
Lead the implementation, migration and validation of research data systems.
Lead industry initiatives, committees and working groups.
Contribute to lessons learned as routine part of project lifecycle.
Actively plan, manage, and report on work status; seek efficiencies wherever possible.
Always work toward positive and effective relationships with informatics staff and collaborators.
Provide informatics support on research projects, including: requirements analyses, design, implementation and ongoing support for the research objectives.
Leverage cross-discipline training and experience to capture project requirements, while facilitating participation by clinical, scientific, operational and information technology stakeholders.
Consult on and provide direct technical support for research projects of high strategic value, complexity and often requiring novel solutions.
Hold expert knowledge in domain modeling, relational database design, programming language(s), XML, data transfer methods, HL7, DICOM and CDISC standards and/or analytical techniques used in research programs. Maintain an understanding of emerging tools and technologies.
Maintain knowledge of statistical principles and analyses considerations for contribution during planning phase of clinical and translational research.
Have significant domain experience within one or more specialty area (e.g. clinical area or research focus) of clinical or translational research and maintain knowledge of terminologies and coding procedures used in research and the healthcare environment.
Support the transfer of adopted technology, tools or methods into routine organizational activities through training, tools development and process documentation.
Author and provide expert guidance on artifacts from domain modeling efforts.
Analyze, adopt and maintain new technologies/systems supporting data acquisition, integration and reporting activities to be used in clinical research projects, typically across research programs or organizations.
Work closely with Information Technology (IT) support for network, database, and hardware/software from requirements throughout the Software Development Lifecycle representing the clinical or translational research project requirements.
Lead validation & user acceptance testing as needed.
Develop custom ad hoc reports and tools in support of clinical data management requirements.
Lead the further development of project-specific products or lessons that can be utilized by other projects and organizations.
Understand requirements presented by different types of data (i.e. clinical data, administrative data, imaging, and newer high-volume data sources).
Ensure semantics and context of data is maintained during collection, processing and reporting.
Troubleshoot issues across projects, identifying the underlying root causes and improvements for efficiency.
Support mapping data structures and values from one dataset into another.
Independently perform highly complex data analyst functions to generate knowledge via data mining, visualization or other analytics. Oversee others performing these activities. Lead the creation of best practices, resources and tools that enable new analytical capabilities.
III: Design into research programs the mechanisms to formally evaluate informatics methods and products and contribute the generalization of these findings to the broader community.
Educate internal and external partners on the value, role and methodology provided by biomedical informatics. Provide training on biomedical informatics-related concepts, applications and tools.
Maintain working knowledge of biomedical informatics, including technology, standards, systems and methodologies used in health care and research.
Develop and conduct training sessions for internal and external staff on a regular basis; present at conferences and/or publish in peer reviewed journals.
Contribute to department training and development infrastructure including identification of training needs, ensure that training reflects local and industry standards.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Work requires graduation from an accredited Master’s degree program providing training in biomedical informatics, or related field of study and 5 years of biomedical informatics experience to include one year of supervisory experience; or
Completion of a Bachelor’s degree with seven years of experience supporting biomedical informatics projects, including two years in clinical or translational research, plus one year of supervisory experience.
Ph.D. is preferred.
None required beyond that described above.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
About Duke Clinical Research Institute
Duke Clinical Research Institute