Clinical Research Coordinator

3 weeks ago

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

The Clinical Research Coordinator will provide support, coordination, and leadership for research studies at the Minneapolis Heart Institute Foundation. This role will ensure the smooth and accurate progress of clinical studies in accordance with all legal and regulatory standards. The successful candidate will assist with documentation for Institutional Review Board (IRB) submissions, recruit and screen study participants, and help facilitate their continued participation. Additionally, the Clinical Research Coordinator will abstract data from electronic medical records (EMR) and other sources, collect and submit study data and regulatory documents, and ensure compliance with study protocols.

Responsibilities

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

  1. Manage other projects and complete various tasks as assigned by MHIF Leadership.
  2. Provide mentorship/preceptor as assigned.
  3. Participate 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.

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