Clinical Informatics Systems Specialist

The Clinical Informatics System Specialist (CISS) exists to ensure that new protocols are configured completely and accurately in the CTMS system, to support clinical teams in protocol execution and management. Specifically, this role will translate clinical trial Schedule of Assessments (SOE) - through conversations with subject matter experts - into functional requirements, specified in an appropriate level of detail that can be used for application configuration by the Clinical Trial Management Software (CTMS). The CISS is also responsible for working with the Subject Matter Experts (SMEs) and leadership to create, edit and confirm accuracy of supporting clinical documentation to include but not limited to: Eligibility Checklists, Study Schedules, supporting assessment tools and other documents as identified.

Essential Responsibilities:

• Serve as a liaison between the subject matter experts and the application core team to gather and communicate requirements which help define and verify application configuration.
• Translate (As applicable) calendars created by outside teams into START-approved calendars, including language translation for Spanish sites if necessary.
• Coordinates the activation of all new and legacy clinical trial calendar building and general study set up activities with internal and supporting external entities within the timeline parameters of Site Initiation Visits.
• Using Oncore/Excel /Word, develops study tools, including but not limited to eligibility checklists, calendars and schedules, C1D1 checklists, supporting assessment tools, PK and EKG flow sheets (as required) and other documents as identified in collaboration with the Research Nurse, Study Coordinator and/or Principal Investigator.
• Updates pertinent Oncore Reviews data in a timely manner to facilitate Amendment receipt/approval, Consent /Re-Consent requirements and clinical trial status updates.
• Build strong relationships with project leadership, subject matter experts, clinical application colleagues and financial budget team members.
• Work with SMEs and project leadership to complete workflow decisions, workflow documentation, and supporting policies.
• Ability to understand the organization’s strategic priorities and adapt project timelines and tasks accordingly.
• Ability to escalate risks or issues effectively within the organization, if needed.
• Ability to identify and manage scope changes during the course of a project.

• Bachelor's Degree with at least 2 years of experience in the clinical research industry, or equivalent education and experience
• Demonstrate accountability in project ownership and solution-oriented work approach
• Creative problem-solving skills; ability to navigate through complex Phase I Oncology Protocols and apply to START’s Mission of quality data collection
• Proven organizational skills including attention to detail and multi-tasking skills
• Excellent verbal and written communication skills
• Strong working knowledge of Microsoft Excel, Word, and PowerPoint
• Software implementation experience, preferred
• Prior CTMS experience, preferred
• Spanish speaking, preferred

Working Conditions:

• Remote