Pediatric Research Project Coordinator

Job Description:

The Clinical Research Project Coordinator position provides research project support to the requesting department, ensuring timely and effective activation and completion of research projects. Responsibilities include routine to moderately complex project coordination and management, as well as communication and documentation as required by the research departments and specific assignments within the research program.

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, database, internet, e-mail, and scheduling applications.
• Ability and willingness 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.
• Bachelor's Degree in a clinical or life science field, business, or healthcare operations. A degree must be obtained through an accredited institution. Education is verified. 
• Two (2) 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.

Preferred Qualifications

• Experience in clinical research setting, including relevant study management experience.
• Experience in a healthcare or hospital setting.  

Physical Requirements:

Physical Requ