OFFICE OF CLINICAL RESEARCH (UA-CLTO-IUINA)

The Clinical Research Management System (CRMS) Study Specialist is responsible for the planning and implementation of study-specific projects within OnCore CRMS. This primarily includes, but is not limited to development, creation, and maintenance of protocol-specific study calendars built for use in subject visit tracking, financials management, research billing, coverage analysis, specimen tracking, and clinical study data capture. The role requires extensive collaboration with study teams, data managers, clinical staff, and financials staff, and a general understanding of clinical research processes.

Department-Specific 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.

General Responsibilities

• 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.

Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.

EDUCATION

Required

• Bachelor's degree (preferably in a related field).

WORK EXPERIENCE

Required

• Experience in technical project/program support or a related field.

Preferred

• Experience working within a medical or clinical research setting
• Experience working in a clinical research management system, specifically OnCore
• Experience interpreting research protocols

SKILLS

Required

• 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.

This role requires the ability to effectively communicate and to operate a computer and other standard office productivity equipment. The position involves sedentary work as well as periods of time moving around an office environment and the campus. The person in this role must be able to perform the essential functions with or without an accommodation.

This is a fully remote position. However, this is subject to change in the future based on university policy and business needs.

For full-time staff employees, Indiana University offers a wide array of benefits including:

• Comprehensive medical and dental insurance
• Health savings account with generous IU contributions
• Healthcare and dependent care flexible spending accounts
• Basic group life insurance paid by IU
• Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death & dismemberment insurance
• Base retirement plan with generous IU contributions, subject to vesting
• Voluntary supplemental retirement plan options
• Tuition subsidy for employees and family members taking IU courses
• 10 paid holidays plus a paid winter break each year
• Generous paid time off plans
• Paid leave for new parents and IU-sponsored volunteer events
• Employee assistance program (EAP)

Learn more about our benefits by reviewing the IU Benefit Programs Brochure.

Career Level: Core

FLSA: Exempt

Job Function: Information Technology

Job Family: IT Project Management

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This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.

If you wish to include a cover letter, you may include it with your resume when uploading attachments.

Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information.

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Telephone: 812-856-1234