Clinical Research Management System Study Specialist (IT Project Management Specialist)

Indiana University is seeking a Clinical Research Management System Study Specialist to oversee study-specific projects within OnCore CRMS. The role involves extensive collaboration with various stakeholders to ensure effective study calendar creation, maintenance, and compliance with research protocols.

Responsibilities:

• Responsible for the planning and implementation of study-specific projects within the OnCore CRMS, often involving university staff from different teams and external partners on interrelated project tasks
• Reviews study information submitted to the Office of Clinical Research (OCR) and creates protocol entries in OnCore based off the information provided
• Conducts thorough analysis of research protocols to determine required visits and procedures needed for calendar creation
• Creates and amends study-specific calendars in OnCore CRMS
• Meets with clinical research coordinators, business managers/financials staff, biostatistics data managers, and/or lab staff to discuss functionality of OnCore calendars and ensure study-specific needs are met
• Works closely with the OCR Finance and Coverage Analysis Team to ensure OnCore calendar builds meet coverage analysis and research billing needs
• Monitors progress of projects to ensure that quality constraints and timelines are met
• Provides ongoing instructional guidance, training, and support for various levels of research personnel
• Assists with identifying system needs and developing processes with regards to study calendar creation and maintenance
• Responds to inquiries of ranging complexity from faculty and staff regarding clinical research management and processes related to OCR Research Systems
• May provide user support to research personnel in regards to study calendar utilization as well as basic OnCore functionality and processes
• Plans and implements IT project(s), often involving university staff from different teams and external partners on interrelated project tasks
• Designs, creates, executes, and balances project work plans and work-flow documents; works within project timelines and proposes revisions as appropriate to meet changing needs and requirements
• Stays within budget constraints and monitors progress of projects to ensure that quality and cost constraints are met
• Reports and documents project milestones to share with leaders, stakeholders, and/or project partners
• Researches and stays up to date with IT project management best practices, approaches, and trends
• May provide guidance to temporary or hourly staff

Requirements:

• Bachelor's degree (preferably in a related field)
• Experience in technical project/program support or a related field
• Proficient written and verbal communication skills
• Maintains a high degree of professionalism
• Demonstrated time management and priority setting skills
• Demonstrates a high commitment to quality
• Possesses flexibility to work in a fast-paced, dynamic environment
• Seeks to acquire knowledge in area of specialty
• Experience working within a medical or clinical research setting
• Experience working in a clinical research management system, specifically OnCore
• Experience interpreting research protocols