Clinical Research Project Coordinator II or Senior

$61,693 - $97,178/Yr

Intermountain Health - Madison, WI

Full-time - Mid Level

Madison, WI

Hospitals

About the position

The Clinical Research Project Coordinator II (Phase I & CAR-T) or Senior level coordinator role is essential in supporting research projects across various departments, ensuring timely activation and successful completion of research initiatives. This position involves expert coordination and project management, meticulous communication, and documentation to meet the specific needs of research departments.

Responsibilities

• Provide expert support for complex clinical research studies and departments across the Intermountain system.
• Define, develop, and execute clinical research project plans, including detailed work plans and schedules.
• Manage complex project plans and identify needed resources, roles, and responsibilities for assigned studies.
• Develop and manage comprehensive budget and scope documents for clinical research studies.
• Track expenses, forecast financial needs, and assist with business case and proposal development.
• Ensure compliance with study requirements, sponsor guidelines, and regulatory standards.
• Lead quality assurance initiatives, document deliverables, and prepare comprehensive reports and presentations.
• Oversee study startup, maintenance, and closeout activities.
• Lead the development and review of Medicare Coverage Analysis for clinical trials.
• Train and mentor research staff on regulatory requirements, procedures, and best practices.
• Communicate effectively with high-level stakeholders and act as a senior liaison between the research team and regulatory bodies.

Requirements

• Experience in a role requiring effective organizational skills and professional communication skills.
• Demonstrated experience working in a collaborative team environment.
• Experience using word processing, spreadsheet, database, internet, e-mail, and scheduling applications.
• Ability to travel within the Intermountain system and work from different locations as assigned.
• Three (3) years of experience in a research or relevant healthcare/business role requiring strong attention to detail.

Nice-to-haves

• Bachelor's Degree in a clinical or life science field, business, or healthcare operations.
• Four (4) years of experience in a research or relevant healthcare/business role.
• Basic knowledge of Local Coverage Determinations (LCDs) and National Coverage Determinations (NCDs).
• Experience in a clinical research setting, including relevant study management experience.

Benefits

• Comprehensive benefits package covering a wide range of programs to foster wellness.
• Support for living healthy, happy, secure, connected, and engaged.