Research Finance Specialist I - Pre-Award

**Where Purpose Meets Progress** At the Minneapolis Heart Institute Foundation (MHIF), your work unlocks new knowledge, supports patient-centered care, and advances cardiovascular research and education. As a Research Finance Specialist 1 – Pre-award, you’ll do more than support studies—you’ll help propel a mission that changes and saves lives. **Summary** The Research Finance Specialist 1 – Pre-award supports operational, financial, regulatory, and system-related activities required for clinical research study start-up and activation. This role is responsible for coordinating and supporting pre-award activities across the clinical research lifecycle, including study intake, feasibility review, study start-up coordination, coverage analysis, budget development, contract support, document consistency review, and CTMS builds. **Primary Responsibilities** - Support intake and start-up activities for clinical research studies across industry-sponsored and investigator-initiated programs. - Coordinate and track study start-up workflows, activation timelines, and required approvals to support efficient study implementation. - Support operational, financial, and research feasibility assessments in collaboration with investigators, study teams, and operational stakeholders. - Assist in validation of coverage analysis reviews by evaluating clinical protocols, informed consent forms, budgets, contracts, and related study documents to determine billable versus sponsor-funded items and services. - Assist in developing study billing grids, billing designations, and research financial workflows to support research billing compliance and operational readiness. - Assist in developing clinical trial budgets, pricing reviews, and financial assessments in partnership with study teams, ancillary departments, organizational stakeholders and 3rd party partners. - Support budget negotiations and financial discussions with sponsors and Clinical Research Organizations (CROs) in collaboration with research administration and contracting teams. - Assist in reviewing and coordinating research agreements, including Clinical Trial Agreements (CTAs), Confidentiality Agreements (CDAs), subcontracts, and related research documents. - Collaborate with legal, compliance, finance, and operational teams to support contract execution workflows and ensure consistency among study budgets, contracts, and operational requirements. - Perform quality review of study documents and research systems to ensure consistency across protocols, informed consent forms, budgets, contracts, coverage analyses, regulatory documentation, and research systems. - Identify discrepancies, documentation gaps, billing risks, or funding concerns and communicate findings to appropriate stakeholders. - Support research study build activities within Clinical Trial Management Systems (CTMS), financial systems, and related operational platforms, including workflow validation and issue resolution. - Coordinate with IT, research administration, billing, and operational teams to support accurate system configuration and downstream financial and compliance processes. - Maintain organized study documentation, tracking tools, and activation records to support audit readiness and institutional compliance requirements. - Facilitate communication between internal stakeholders and external sponsors, CROs, and partner organizations regarding study activation requirements, contracting milestones, and operational readiness. - Participate in process improvement initiatives designed to enhance research operations, compliance, and study start-up efficiency. - Partner with key stakeholders to ensure compliance with CMS, FDA, HIPAA, Good Clinical Practice (GCP), and institutional research requirements. - Other duties as assigned – this position may support other functions as required by business need. This job description represents the major functions of the position but is not intended to be all-inclusive. **Re…