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. Support trial implementation in a variety of clinical settings including ambulatory clinic, inpatient areas, and procedure areas.
Numbers & Facts
Location
St Paul, Minnesota
Salary
$81,702.40–$115,336 Per Year
Description
Responsibilities/Job Description:
Job Overview
In this role, you will:
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
Required
Education:
Associate's Degree in Nursing
Experience:
2 years clinical nursing experience
2 years Clinical Research experience
1-5 years research experience
Preferred
Education:
BSN degree
Experience:
Cardiology, Diabetes, Acute Care, Critical Care, Cardiovascular lab, and electrophysiology experience
License/Registration/Certification:
BLS
Clinical Research Coordinator Certification (CCRC) through Association of Clinical Research Professionals
Certified Clinical Research Professional (CCRP) through Society of Clinical Research Associates