Clinical Research Coordinator

1 week ago

Minneapolis, Minnesota, United States Mlnneapolis heart institute foundation Full time
Job Summary

We are seeking a highly skilled and detail-oriented Clinical Research Coordinator to join our team at the Minneapolis Heart Institute Foundation. The successful candidate will provide support and coordination for research studies, ensuring smooth and accurate progress in accordance with legal and regulatory standards.

Key Responsibilities
  • Human Subject Protection
    • Determine subject eligibility based on protocol inclusion and exclusion criteria.
    • Ensure informed consent process is correctly followed.
    • Address subject questions and concerns in a timely manner.
    • Assess subject participation at each protocol required visit.
    • Properly identify, document, and report Institutional Review Board (IRB) mandated information.
  • Study Coordination
    • Conduct and document informed consent process prior to protocol required testing.
    • Ensure accurate and timely data entry.
    • Maintain accurate test article accountability and reconcile as needed.
    • Complete subject visit requirements per study protocol.
    • Follow FDA Regulations, Good Clinical Practice (GCP) guidelines, IRB Policies, and Minneapolis Heart Institute Standard Operating Procedures (SOP).
  • Data Integrity
    • Ensure adherence to MHIF Conflict of Interest (COI), confidentiality policies, and Employee Code of Ethics.
    • Complete Case Report Forms (CRF) in a timely and accurate manner.
    • Resolve data queries per study timeline.
    • Ensure accuracy of all study data.
Secondary Responsibilities
  • Manage other projects and complete various tasks as assigned by MHIF Leadership.
  • Provide mentorship and preceptorship as assigned.
  • Participate in Research and/or MHIF organizational quality improvement initiatives.
Requirements
  • CRC certification through the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA) within two years of hire.
  • Valid Minnesota Registered Nurse (RN) license for some positions.
  • Associate or Bachelor's degree.
  • A minimum of two years' clinical experience.
  • Proficiency in MS Office, MS Outlook, and electronic medical record systems (Epic).
  • Strong interpersonal skills and ability to work effectively in a team environment.
  • Ability to manage multiple projects and prioritize tasks.
  • Strong attention to detail and ability to pass institution's compliance requirements.
Preferred Qualifications
  • Previous cardiovascular and/or research experience.
  • Certified Clinical Research Coordinator/Professional (CCRC or CCRP) certification.
  • NIHSS Certification.

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