Research Finance Specialist I - Pre-Award

Minneapolis heart institute foundation•Minneapolis, MN

6d•$65,000 - $75,000•Onsite

About The Position

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.

Requirements

Two or more years of experience in clinical research administration, research finance, study start-up, budgeting, contracting, coverage analysis, research compliance, or related healthcare or research operations.
Working knowledge of clinical research operations, study start-up processes, and research billing compliance principles.
Experience reviewing and interpreting clinical protocols, informed consent forms, study budgets, contracts, and regulatory documentation.
Familiarity with Medicare research billing requirements, CMS Clinical Trial Policy, FDA regulations, Good Clinical Practice (GCP), HIPAA, and related federal research regulations.
Proficiency in Microsoft Office applications, including strong Excel skills.
Strong analytical thinking, organization, communication, problem-solving, and customer service skills, with the ability to manage multiple studies and competing priorities in a fast-paced research environment.

Nice To Haves

Bachelor's degree in healthcare administration, business administration, finance, nursing, life sciences, public health, or a related field preferred. Equivalent combinations of education and relevant clinical research experience may be considered.
Experience with coverage analysis processes, investigational drug and device studies, and research financial workflows preferred.
Experience with Electronic Health Record (EHR) systems, Clinical Trial Management Systems (CTMS), and related research administration platforms preferred.

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.