Clinical Research Project Coordinator

Job Description:

Make an Impact on Human Research and Patient Care!

Join a dynamic team dedicated to advancing ethical, compliant, and innovative research across our organization. As a Research Regulatory Coordinator, you will play a key role in supporting the Human Research Protection Program (HRPP), Institutional Review Board (IRB), and Research Conflict of Interest Program by providing critical regulatory, administrative, and operational support for human subjects research activities.

In this highly collaborative role, you will review and evaluate research studies to ensure compliance with federal regulations, state laws, institutional policies, and accreditation standards. Working alongside investigators, study teams, compliance partners, and institutional stakeholders, you will help foster the ethical conduct of research while supporting groundbreaking studies that improve patient care and outcomes.

If you are passionate about research integrity, regulatory excellence, and making a meaningful impact within healthcare, we encourage you to apply and be part of a team that helps shape the future of human subjects research.

Work Schedule

• Hybrid role – Position requires on-site presence at times for training and meetings, with flexible scheduling.
• Core business hours: Monday–Friday, 7:00 a.m. – 5:00 p.m.

Essential Functions

• Research Support and Administration: Support various clinical research studies and departments across the Intermountain system. Based on role, may coordinate (1) review of IRB/HRPP submissions and provide support to research oversight committees and research programs, coordinate review and oversee submission, or (2) centralized administrative and technical functions associated with grants, contracts and other agreements from external funding sources.
• Project Planning & Execution: Define, develop, and execute clinical research project plans, including work plans and schedules. Identify needed resources, roles, and responsibilities for assigned studies. Facilitate feedback from key participants and participate as a team member when needed.
• Budget & Scope Management: Develop comprehensive budget and scope documents for clinical research studies. Assist with business case and proposal development, including budget preparation and completion of required forms for internal and external routing.
• Study Requirements & Compliance: Analyze study requirements to ensure sponsor and study requirements are met. Communicate impacts on existing studies to internal and external stakeholders. Look for cost-effective methods to facilitate study execution while meeting functional and regulatory requirements.
• Quality Assurance & Documentation: Participate in quality assurance plans and reviews as requested. Document clinical research study deliverables, track and communicate timelines, and prepare reports and presentations on findings. Ensure completion of deliverables per specified deadlines. Support research billing by reviewing research accounts and reconciling invoices.  
• Study Lifecycle Management: Manage study startup, maintenance, and closeout activities. Provide support and guidance to Clinical Research study teams on study financials, and act as a source expert and liaison. As requested, provide support and back up as clinical research coordinator.
• Medicare Coverage Analysis: Support the development of Medicare Coverage Analysis for clinical trials. Draft and prepare coverage analysis documents, review reimbursement guidelines, ensure correct billing, and provide coverage review.
• Auditing & Risk Management: Coordinate project assessments and response planning. Communicate risks, develop and execute strategies, and lead auditing activities to ensure compliance with guidelines and regulations.

Skills

• Budgeting
• Financial negotiation
• Attention to detail
• Multitasking
• Clear written and verbal communication
• Task Prioritization
• Process Improvement
• Critical thinking
• Collaboration
• Research

Minimum Qualifications

• Experience in a role requiring effective organizational skills; effective follow-through, and commitment to excellence, effective professional communication skills; Ability to communicate with others in a clear, understandable, and professional manner as well as strong interpersonal skills: Ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues within an often-sensitive political environment.
• Demonstrated experience working in a collaborative team environment.
• Experience using word processing, spreadsheet, dat