Supports technical aspects of implementing, maintaining, and evaluating Research Application within the Office of Research Operations (ORO). This role is responsible for application support (Advarra eRegulatory System), issue resolution, end-user support, auditing and data analysis to ensure quality and compliance. The Research Operations Application Support Analyst will support all efforts and facilitate cross-functional collaboration of the Research Applications within the Research Operations portfolio

1. Serves as part of a team to act as the system administrator/point of contact in support of the management and administration of the Advarra eRegulatory (eReg) Management System, and other research administration systems, as needed.

   System Responsibilities

   • Demonstrates an understanding of the technical aspects of applications, as well as the operational details, work flows and how applications are used in the department.
   • Monitor and support integrations between research administration systems, including setting up and maintaining application data exchange.
   • Participate in system upgrades and modifications, including identifying requirements, configuration, testing, and deployment.
   • Develops, modifies, and tests user roles, designs access rights, and configures applications for use by users.
   • Oversees administrative aspects of the applications, such as adding new user roles, new data sets, etc.
   • Provides support and is the technical resource for complex issues escalated to teammates and/or product vendor(s).
   • Coordinates with the application vendors on system configuration and support questions.
   • Participate in vendor meetings, capture and synthesize key outcomes, and communicate relevant updates and action items to the Product Owner
   • Ensures 21 CFR 11 compliance with applicable systems, including coordinating the evaluation of upgrades on the test environment and leading the validation to assess risk and follow change control procedures. Maintains and follows all system standard operating procedures, ensuring the system remains validated.
   • Leads system audits and non-conformance reviews per standard operating procedures.

    

   Data Reporting and Other Data Needs

   • Collaborates with ORO offices to develop and manage reports and participate in integrations as needed for new or updated applications.
   • Maintains administrative tracking documentation (change log/test plans/training and end-user support document inventory).
   • Examines complex data to optimize the efficiency and quality of collected data and resolves data quality problems.
   • Reviews reporting requests and analyzes the business requirements to determine custom report development.
   • Collaborates with external and internal stakeholders on the organization’s application and reporting requirements for research administration while eyeing continuous process improvement, efficiency, and optimization.

    

   Outreach and Education

   • Collaborates with cross-functional teams to improve institutional workflows and provide system support including functioning as the liaison with other IS teams and business partners and maintains project tracking information.
   • Hosts routine meetings with the vendor’s support team(s) as needed.
   • Assists the ORO offices with reviewing all training and education materials for final review before release.
   • Lead or facilitate training for end users, including revising vendor training and other outreach materials; lead or facilitate form build and training for end-users;.

   Performs other duties as required or assigned.

• Bachelor’s degree with 3 years of system support experience, or the equivalent.
• Must have strong computer skills.
• SQL skills preferred.
• Prior experience with clinical research administration systems preferred.
• Must be self-directed, flexible, and have excellent organizational skills.
• Excellent written and verbal interpersonal communication skills required.
• Must have an analytical approach to problem solving and needs definition.
• Remote work experience preferred, but not required.

• None