CRC I

Where Purpose Meets Progress

Job 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.

Provides 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

Secondary Responsibilities

• Contributes to Research and/or MHIF organizational improvement initiatives as delegated by MHIF leadership.
• May contribute to dissemination of research by drafting text and/or charts for abstracts, manuscripts and post/Power Point presentations.
• Managers other projects and completes various tasks as assigned by MHIF Leadership.

Relationships

This position reports to the Clinical Research Manager who reports to the Director of Clinical Operations. The incumbent interacts regularly with other members of the Clinical Research team, Minneapolis Heart Institute (MHI) physicians, staff and patients.

Core Values in Action

At MHIF, our values aren't just words -- they guide how we lead and work together:

What Sets You Apart

Required:

• CRC’s with experience are required to pass CCRC certification through the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA) within two years of date of hire.
• Associate or Bachelor’s degree.
• A minimum of one year of clinical experience.
• Proficiency in MS Office, MS Outlook and electronic medical record systems (Epic).
• Strong interpersonal skills with the ability to work with others as a team and in support of a positive work culture.
• Ability to work effectively managing multiple projects.
• Strong attention to detail.
• Must be able to pass institution’s compliance requirements, EMR (Epic) and Collaborative Institutional Training Initiative (CITI). (Incumbents assigned to National Institutes of Health (NIH) trials must be able to pass NIH mandated training prior to the start of the study.)
• Basic Life Support (BLS) certification

Preferred:

• Previous cardiovascular and/or research experience preferred.
• Certified Clinical Research Coordinator/Professional (CCRC or CCRP) certification.
• NIHSS Certification

Physical Demands

Must be able to work at a computer or stand for long periods of time. Must be able to lift heavy objects of up to 20 lbs.

Additional Comments

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

Work Environment

Working in an office cube in a typical office setting; working in patient care area such as a clinic and/or hospital.

Total Rewards

In addition to meaningful, mission-driven work, MHIF offers:

Competitive salary range of $55,000 - $65,000

Comprehensive benefits including:

• Medical, dental, and vision insurance
• Life, short- and long-term disability
• Employer HSA contribution
• 401(k) with employer match and contribution
• Generous PTO, paid holidays, and parental leave
• Tuition reimbursement and paid volunteer time