Senior Business Systems Analyst - Comprehensive Cancer Center
About The Position
Responsible for daily oversight and operation of CRI-supported applications. Manages troubleshooting, administers and controls user access, conducts access audits, and documents standard operating procedures for application-related processes. Coordinates with system vendors, clinical research operations, and informatics engineers to test, validate, and implement new or revised modules within Clinical Research Enterprise systems. Assists in updating validation documentation and Standard Operating Procedures to ensure compliance with FDA 21 CFR Part 11 and other applicable regulations. Leads and facilitates cross-functional collaboration with multi-disciplinary teams across the medical center's clinical research enterprise, including information technology, research billing, and clinical trials offices. Participates in developing strategic plans for system upgrades and implementations across the Clinical Research Informatics environment. This includes an enterprise clinical trials management system, FDA-compliant (21 CFR Part 11) electronic data capture (EDC), eRegulatory binder (eReg), lab information systems, clinical trials matching, integrated electronic medical record (EMR) systems, and EMR functionality that supports clinical trials. Acts as a technical contributor in planning, development, integration, and support of OSUMC Clinical Research Enterprise systems, aligned with the strategic objectives of the research organization and the needs of clinical research stakeholders. Creates, implements, and maintains formal training manuals and procedures per industry and federal guidance and collaborates with end-user system training team(s) for implementation and updates. Provides guidance and serves as a subject matter expert resource for colleagues. Oversees the collection of data requirements for research protocol reporting of clinical trial activities, system notifications, and related data visualization tools. Collaborates with data managers and clinical trials subject-matter experts to prepare data for major initiatives and grants, including NIH and NCI. Must demonstrate excellent oral and written communication, facilitation skills, consensus-building abilities, and the capacity to work independently.
Requirements
- Bachelor’s degree in health science; advanced degree preferred or equivalent combination of education and experience in clinical trials management systems or clinical research operations (such as coordinator, regulatory, auditor, etc.).
- Four to eight years of relevant clinical experience in a clinical research setting with subject matter expertise in clinical trial workflows and the ability to navigate complex protocols.
- Expertise in clinical trial data requirements, regulatory affairs, case report form (CRF) development, and protocol development is required.
- Knowledge and experience with clinical trial management systems and electronic health records are required.
- Advocacy, interactions with, and knowledge of principal investigator and staff roles within the medical center's clinical research enterprise, as well as engagement with key OSU committees related to the Institutional Review Board (IRB).
Nice To Haves
- Knowledge of business intelligence tools and report formatting applications (Excel, Tableau, Power BI) is preferred.
- IT work experience is also preferred; extensive experience in clinical trials or research environments, gathering and understanding technical and end-user requirements, is valuable.
- Experience developing workflows and user documentation is a plus.
Responsibilities
- Daily oversight and operation of CRI-supported applications.
- Manages troubleshooting, administers and controls user access, conducts access audits, and documents standard operating procedures for application-related processes.
- Coordinates with system vendors, clinical research operations, and informatics engineers to test, validate, and implement new or revised modules within Clinical Research Enterprise systems.
- Assists in updating validation documentation and Standard Operating Procedures to ensure compliance with FDA 21 CFR Part 11 and other applicable regulations.
- Leads and facilitates cross-functional collaboration with multi-disciplinary teams across the medical center's clinical research enterprise, including information technology, research billing, and clinical trials offices.
- Participates in developing strategic plans for system upgrades and implementations across the Clinical Research Informatics environment.
- Acts as a technical contributor in planning, development, integration, and support of OSUMC Clinical Research Enterprise systems, aligned with the strategic objectives of the research organization and the needs of clinical research stakeholders.
- Creates, implements, and maintains formal training manuals and procedures per industry and federal guidance and collaborates with end-user system training team(s) for implementation and updates.
- Provides guidance and serves as a subject matter expert resource for colleagues.
- Oversees the collection of data requirements for research protocol reporting of clinical trial activities, system notifications, and related data visualization tools.
- Collaborates with data managers and clinical trials subject-matter experts to prepare data for major initiatives and grants, including NIH and NCI.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
