Clinical Research Coordinator

Fairview Health Services; Saint Paul (MN); On-site; USD 55,000 - 75,000; Full time

Job summary

Fairview Health Services seeks a Clinical Research Coordinator to join our team at the Community Health & Wellness Hub in St. Paul, MN. The role coordinates all aspects of clinical trials from protocol development through closeout, working with a multidisciplinary team to ensure regulatory compliance and participant safety.

The ideal candidate will hold a health-care related degree (B.S./B.A. or advanced degree) and have experience with Epic EMR, IRB submissions, and GCP guidelines.

Qualifications

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

Responsibilities

• Partner with Recruitment to screen potential participants and understand trial criteria
• Conduct detailed analysis of study protocol to support budget/contract negotiations
• Identify and recommend enrollment goals and recruitment strategies
• Create study-specific tools in the EMR (Epic) and materials for protocol implementation
• Collaborate on preparing regulatory documents (IRB application, informed consent, recruitment materials)
• Educate internal and external parties about new studies and protocol implementation
• Coordinate trial visits with Physicians and APPs; provide necessary resources
• Ensure participant safety and rights; adhere to GCP and IRB requirements
• Participate in site initiation meetings
• Conduct informed consent processes per regulatory standards
• Perform follow-up visits and document per Good Documentation Practices
• Ensure data reporting completeness and accuracy

Skills

Regulatory knowledge

IRB/GCP compliance

Epic EMR navigation

Education

B.S./B.A. in health care or related

Advanced degree in health care or related

Tools

Epic EMR

Job description

Job Overview

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.

Position Details

• 1.0 FTE (80 hours per pay period)
• day shift
• as needed weekends
• onsite role

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 Qualifications

• 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

Benefit Overview

Fairview offers a generous benefit package including but not limited to medical, dental, vision plans, life insurance, short-term and long-term disability insurance, PTO and Sick and Safe Time, tuition reimbursement, retirement, early access to earned wages, and more! Please follow this link for additional information: https://www.fairview.org/careers/benefits/noncontract

Compensation Disclaimer

An individual's pay rate within the posted range may be determined by various factors, including skills, knowledge, relevant education, experience, and market conditions. Additionally, our organization prioritizes pay equity and considers internal team equity when making any offer. Hiring at the maximum of the range is not typical. If your role is eligible for a sign-on bonus, the bonus program that is approved and in place at the time of offer, is what will be honored.

EEO Statement

EEO/Vet/Disabled: All qualified applicants will receive consideration without regard to any lawfully protected status