Clinical Research Project Coordinator II or Senior

$61,693 - $97,178/Yr

Intermountain Health - Helena, MT

Full-time - Mid Level

Helena, MT

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 managing routine to moderately complex projects, providing expert coordination and project management, and maintaining meticulous communication and documentation to meet the specific needs of research departments.

Responsibilities

• Provide expert support for various complex clinical research studies and departments across the Intermountain system, ensuring high-quality execution and compliance.
• Define, develop, and execute sophisticated clinical research project plans, including detailed work plans and schedules, and resource allocation.
• Manage more complex project plans and identify needed resources, roles, and responsibilities for assigned studies.
• Facilitate feedback from key participants and lead project teams as needed.
• 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.
• Create and oversee budgets, track expenses, and forecast financial needs for the clinical research project.
• Ensure compliance with study requirements, sponsor guidelines, and regulatory standards.
• Lead quality assurance initiatives, document deliverables, and prepare comprehensive reports and presentations.
• Communicate impacts on existing studies to internal and external stakeholders.
• Implement cost-effective methods to facilitate study execution while meeting functional and regulatory requirements.
• Support research billing by reviewing research accounts and reconciling invoices.
• Oversee study startup, maintenance, and closeout activities.
• Provide expert backup and support as a Clinical Research Coordinator (CRC) and act as a source expert and liaison.
• Lead the development and review of Medicare Coverage Analysis for clinical trials, ensuring correct billing and compliance with reimbursement guidelines.
• Train and mentor research staff on regulatory requirements, procedures, and best practices.
• Develop and update Standard Operating Procedures (SOPs) and provide advanced education on federal policies and regulations.
• Communicate effectively with high-level stakeholders, including PIs, sponsors, regulatory authorities, study sites, regulatory bodies, researchers, study teams, IRBs, sponsors, CROs, and other third parties.

Requirements

• 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.
• Strong interpersonal skills; ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues.
• 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.
• Occasional overnight travel may be required.
• Clinical licensure, experience or certification may be required due to grant funding requirements.
• Three (3) years of experience in a research or relevant healthcare/business role requiring strong demonstrated attention to detail and ability to adhere to policies and procedures.

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 requiring strong demonstrated attention to detail and ability to adhere to policies and procedures.
• Basic knowledge and ability to interpret Local Coverage Determinations (LCDs) and National Coverage Determinations (NCDs).
• Experience in clinical research setting, including relevant study management experience.
• Experience in a healthcare or hospital setting.

Benefits

• Comprehensive benefits package covering a wide range of programs to foster a sustainable culture of wellness.