Clinical Trial Optimization Lead
Plays a key role in optimizing clinical trial initiation times across the institution. Leads a full range of activities that ensure access to and compliant, effective use of research informatics systems to support a wide variety of research use cases. Guides the design, documentation, testing, implementation, and evaluation of reusable computable phenotypes for clinical trial feasibility and cohort discovery using standardized research informatics systems and workflows to improve institutional efficiencies and optimize resources.
Primary Responsibilities
- Translates sponsor and/or investigator project requirements into actionable knowledge
- Acts as liaison between research teams and biomedical informatics staff to curate reusable computable phenotypes to ensure clinical trial feasibility requirements and turnaround times are met.
- Works closely with research stakeholders to evaluate clinical trial requirements, ensure IRB compliance, and make timely decisions on project feasibility.
- Coordinates intake for research informatics systems access, user experience troubleshooting, and other day to day activities within the department to ensure optimal uptake and use of research informatics tools.
- Manages projects/tasks of any scale with moderate to high complexity while representing the department on larger enterprise-wide project initiatives as needed.
- Monitors process efficiency metrics to support specific institutional goals.
- Provides team updates regularly to review project deliverables and deadlines.
- Shares expertise regarding the various trial feasibility techniques used to elicit, analyze and deliver requirements across a wide variety of clinical research areas.
- Participates in research informatics systems upgrade/conversion testing.
- Leads end-user training and support.
- Recommends solutions to meet research core business needs and coordinates the planning, development, and implementation of these solutions.
Knowledge Skills Abilities
- Knowledge of computers, web-based user interfaces, health care data, clinical research databases, clinical trial recruitment, IRB and HIPAA compliance, and data security.
- Customer support, systems analysis, troubleshooting, problem solving, and listening skills.
Qualifications
Appropriate experience may be substituted for education on an equivalent basis.
Minimum Required Education: Bachelor's degree
Minimum Required Experience: 5 years in clinical research and/or healthcare
Preferred Experience: i2b2 and/or TriNetX; Epic Clarity, Caboodle, Cosmos and/or SlicerDicer; Healthcare revenue cycle operations; Clinical trials feasibility/operations; Medical terminology
Required Certification/Licensure(s):
Preferred Certification/Licensure(s): CCRC, Medical Coding Certification
Physical Requirements
Work requires occasionally lifting moderate weight materials, standing, or walking continuously.
Work Environment
Occasional exposure to dust, noise, temperature changes, or contact with water or other liquids. Work is performed in an environmentally controlled environment.
Sensory Acuity
Ability to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects.