SUMMARY

In support of the Minneapolis Heart Institute Foundation (MHIF) mission, Clinical Research Coordinators (CRC) provide support, coordination and leadership for research studies that may involve industry sponsored Phase I, II, III, and IV clinical trials, drug, biologic, device, government-funded clinical research and investigator-initiated clinical research. They ensure smooth, accurate progress of clinical studies in accordance with all legal and regulatory standards from the planning and approval stages through study completion and post-study closure. CRC’s assist with documentation for Institutional Review Board (IRB)submissions, recruit and screen study participants and help facilitate their continued participation; abstract data from electronic medical records (EMR) and other sources; collect, submit and maintain study data and regulatory documents; ensure compliance with study protocols and participate in initial budget discussion for clinical trials.

Primary Responsibilities:

• Ensures Human Subject Protection
• Determines subject eligibility based on protocol Inclusion and Exclusion criteria.
• Demonstrate the informed consent process was correctly followed.
• Assures all human participant’s questions and concerns are addressed continuously throughout study participation in a timely fashion
• Assesses subject participation at each protocol required visit (consent is a continual process).
• Properly identifies, documents and assist with Institutional Review Board (IRB) mandated reporting.
• Study Coordination
• Conducts and documents informed consent process prior to any protocol required testing
• Assures accurate and timely data entry
• Maintains accurate test article accountability and reconciles as needed
• Completes subject visit requirements per study protocol
• Follows Food and Drug Administration (FDA) Regulations, Good Clinical Practice (GCP) guidelines, IRB Policies and Procedures.
• Follows Minneapolis Heart Institute Standard Operating Procedures (SOP) as well as abiding by Allina Health SOP requirements
• Maintains source and study documents for study lifecycle
• Achieves enrollment goals accounting for variables beyond control
• Maintain Data Integrity
• Ensures adherence of MHIF Conflict of Interest (COI), confidentiality policies and Employee Code of Ethics.
• Completes Case Report Forms (CRF) in a timely fashion and with accuracy
• Resolves data queries per study timeline
• Ensures accuracy of all study data

ADDITIONAL COMMENTS

This job description represents the major functions of the position but is not intended to be all-inclusive.

WHY JOIN MHIF?

“Small team. Global impact.”
Here, your work has purpose. Your voice is heard. Your career can grow. We are driven by discovery and grounded in compassion—and we’re looking for someone who brings both heart and expertise to the table.
Ready to do work that matters?
Visit https://mhif.org/careers to learn more and apply.
MHIF is an equal opportunity employer and values a diverse and inclusive workplace.

WHERE PURPOSE MEETS PROGRESS

At the Minneapolis Heart Institute Foundation (MHIF), your work directly contributes to groundbreaking discoveries, advances in patient care, and the future of cardiovascular research and education. As a Clinical Research Coordinator, you won’t just be coordinating studies—you’ll be helping to drive innovations that improve and save lives.
This is more than a job—it’s a career with global impact, supported by a collaborative, mission-driven community.

SECONDARY RESPONSIBILITIES

• Manages other projects and completes various tasks as assigned by MHIF Leadership
• Provides mentorship/preceptor as assigned
• Participates as needed in Research and/or MHIF organizational quality improvement initiatives.

Primary Responsibilities:

• Ensures Human Subject Protection
• Determines subject eligibility based on protocol Inclusion and Exclusion criteria.
• Demonstrate the informed consent process was correctly followed.
• Assures all human participant’s questions and concerns are addressed continuously throughout study participation in a timely fashion
• Assesses subject participation at each protocol required visit (consent is a continual process).
• Properly identifies, documents and assist with Institutional Review Board (IRB) mandated reporting.
• Study Coordination
• Conducts and documents informed consent process prior to any protocol required testing
• Assures accurate and timely data entry
• Maintains accurate test article accountability and reconciles as needed
• Completes subject visit requirements per study protocol
• Follows Food and Drug Administration (FDA) Regulations, Good Clinical Practice (GCP) guidelines, IRB Policies and Procedures.
• Follows Minneapolis Heart Institute Standard Operating Procedures (SOP) as well as abiding by Allina Health SOP requirements
• Maintains source and study documents for study lifecycle
• Achieves enrollment goals accounting for variables beyond control
• Maintain Data Integrity
• Ensures adherence of MHIF Conflict of Interest (COI), confidentiality policies and Employee Code of Ethics.
• Completes Case Report Forms (CRF) in a timely fashion and with accuracy
• Resolves data queries per study timeline
• Ensures accuracy of all study dat