Clinical Research Coordinator

Fairview Health Services•St. Paul, MN

5d•Onsite

About The Position

Fairview is looking for a Clinical Research Coordinator to join our team at our Community Health & Wellness Hub in St. Paul, MN. The Clinical Research Coordinator coordinates all aspects of clinical trials and research studies from protocol development through closeout. The Clinical Research Coordinator will typically coordinate clinical trials of moderate-risk/complexity. This position is a learned professional responsible for troubleshooting and resolving problems independently and with appropriate research teams and research sources available. Responsible for interpretation, application of and compliance with Federal Regulations, Good Clinical Practice, and University and Clinical Partner policies as it relates to assigned protocols as well as application of subject matter knowledge.

Requirements

B.S./B.A. in health care, scientific or related plus at least 4 years of experience or
Advanced degree in health care, scientific or related plus 2 years of experience or a combination of related education and work experience to equal eight years
Knowledge of navigating Electronic Medical Records - Epic

Responsibilities

Partner with our Recruitment team to develop tools that help recruiters screen potential participants. This includes a thorough understanding of the trial criteria for participation, an understanding of the disease under study and our local population, the fit with current research portfolio, and any external resources that may be needed
Conduct a detailed analysis of study protocol to support budget/contract negotiations
Identifies and recommends start-up enrollment goals and recruitment strategies
Creates study-specific tools in the EMR-Epic and materials for protocol implementation
Collaborates with team members in preparing regulatory documents, including IRB application, informed consent, and recruiting materials
Educates internal and external parties about new studies, providing guidance in understanding and implementing study protocols
Partner with Physicians and Advanced Practice Providers (APPs) for trial visits, including providing needed resources and trial details on an enduring basis throughout the trial
Ensures that the well-being of research participants is safeguarded, and that participant’s rights are protected
Participates in site initiation meeting
Conducts the informed consent process with potential research subjects in accordance with all regulatory, ethical and Institutional Review Board (IRB) requirements
Conducts follow up visits per protocol, within defined parameters, and ensures thorough and accurate documentation using Good Documentation Practices
Ensures study participant safety and clinical trial protocol adherence using Good Clinical Practices
Ensures timely reporting of study required data that is thorough, complete, and accurate
Participates in sponsor study initiation meetings
As needed, provide clinical care, within guidelines
Support trial implementation in a variety of clinical settings including ambulatory clinic, inpatient areas, and procedure areas