Senior Business Systems Analyst - Comprehensive Cancer Center

Position Summary

The Business Systems Analyst (S3) is a fully experienced professional that provides subject matter and technical expertise in clinical research operations and informatics to support, integrate and enhance information technology applications integral to the clinical research mission of the OSUCCC.Applications include but are not limited to an enterprise-level clinical trials management system (CTMS), electronic medical record integration to support clinical research, and clinical trial matching platforms.

As a part of Clinical Research Operations, the Business Systems Analyst is an experienced technical expert and contributes to the OSUCCC strategic initiatives leading implementations, upgrades, and technical support of research informatics applications that support the OSUCCC clinical research mission and the OSUCCC Clinical Trials Office.

• Serves as the point of contact for established application vendors for new interoperability, functionality, products, and services to support clinical research

• Organizes and leads application stakeholders through complex projects such as assessing and implementing new system initiatives and applies industry knowledge to identify system limitations and provide alternate solutions for workflow

• Leads and facilitates cross-functional collaborations with multi-disciplinary entities across the OSUCCC, medical center, and the College of Medicine, including information technology, research billing, clinical trials processing lab, and investigational pharmacy

• Oversees gathering of data requirements for research protocol reporting of clinical trials activities, systems notification, and related data visualization tools

• Works with OSUCCC Clinical Trials Office Quality Data Manager and others to prepare data for significant initiatives and grants such as the NCI Cancer Center Support Grant

• 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

• Application troubleshooting of data integrity, functionality, and interfaces within research applications, electronic medical record, financial systems, investigational pharmacy systems, and others as required

• Ensures that applications meet appropriate regulatory requirements (e.g. 21CFR 11)

• Controlling access, ensuring the privacy and security of sensitive information, and following applicable laws and regulations

Requirements of the role include advocacy and interaction with and knowledge of principal investigator and staff roles within the OSUCCC, the OSUCCC Clinical Trials office and key OSUCCC committees, including the Data Safety Monitoring Committee (DSMC) and Clinical Scientific Review Committee (CSRC), as well as various Institutional Review Boards (IRBs), and external organizations such as the National Cancer Institute (NCI).

Job Requirements

Bachelors Degree in health science or equivalent combination of education and experience in clinical trials management systems, or clinical research operations (coordinator, regulatory, auditor, etc.) required. Four to eight years of relevant background in a clinical research environment with subject matter expertise in clinical trial workflows and the ability to navigate complex clinical trial protocols.

Expertise in clinical trials data requirements, regulatory affairs, development of case report forms (CRF), and protocol development required. Relevant content knowledge of business intelligence tools and report formatting applications (Excel, Tableau, SSRS) preferred. Information technology work experience preferred. Extensive work experience interacting within clinical trials/clinical research environment to gather and understand technical and end-user requirements; experience with developing workflow and user documentation preferred; knowledge and experience with a clinical trials management system and electronic health records required. Must demonstrate excellent oral and written communication, facilitation skills, consensus building, and the ability to work independently.

Information Technology - Business Systems - Individual Contributor - Specialized - S3 Senior