Job Posting: Clinical Research Coordinator I

Salary Range:$60,000.00 To $75,000.00 Annually

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.
• 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

• Manages other project s 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.

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.

Qualification

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.
• Some positions will require a valid Minnesota Registered Nurse (RN) license
• Associate or Bachelor’s degree.
• A minimum of two year’s 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

The compensation range for this role takes into consideration a variety of factors including but not limited to skill sets; experience and training; licensure and certifications; internal equity; and other business and organizational needs. It is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are determined on the facts and circumstances of each case. The current range is $60,000 - $75,000

In addition to salary, MHIF also offers a comprehensive benefits package for employees working 20 hours per week or more including medical, dental, life, and short- and long-term disability insurance, employer contributions toward a health savings account (if applicable), 401(k) with employer match and contribution, paid time off, paid parental leave, tuition reimbursement,  paid volunteer time, and 10 paid holidays annually.

How to Apply

Please visit our website or apply directly using the following link:

Apply Here

Minneapolis Heart Institute Foundation is an EEO/Affirmative Action employer.

Date posted: January 17, 2025