Clinical Research Coordinator Internal Medicine (Diabetes Institute)

Department:

SOM KC The Diabetes Institute (DI)

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Diabetes Institute

Position Title:

Clinical Research Coordinator - Internal Medicine (Diabetes Institute)

Job Family Group:

Professional Staff

Job Description Summary:

The Clinical Research Coordinator in the KU Diabetes Institute works collaboratively with multidisciplinary teams research staff and participants to support the coordination of clinical research studies related to diabetes weight management physical activity and nutrition. Responsibilities include recruiting screening and educating participants; managing study activities such as data collection documentation and analysis; monitoring participant progress and adverse events; and participating in quality assurance audits to ensure compliance with study protocols and regulatory standards.

Job Description:

Job Duties

Study Support & Logistics:

• Assist in recruitment evaluation and education of participants regarding clinical trials following established procedures and protocols.
• Ensure adequate study supplies are maintained and assist with tracking study visits expenditures and reimbursement requests for study-related items.
• Maintain trial regulatory documentation files as directed including correspondence with sponsor IRB departmental support and participants.
• Prepare and organize study-related materials as needed.
• Assist feasibility assessment of research protocol including appropriate patient population budget and specific needs for the study.

Participant Interaction & Support:

• Coordinate study participant visit activities including scheduling procedures and communicating with participants.
• Assist in educating and supporting participants through study procedures and during study interventions.
• Serve as a liaison between participants and the research team for general study-related questions.

Data Entry & Documentation:

• Maintain and update source documents and submit case report forms (CRFs) as required for clinical trials.
• Collect and enter research data into electronic systems (e.g. REDCap Epic) and paper records as needed.
• Ensure proper documentation and organization of study records and maintain compliance with institutional and regulatory standards.
• Recognize and report any adverse or serious events to the Principal Investigator.

Administrative & Compliance Assistance:

• Prepare documentation and participate in study monitoring visits reviews and audits.
• Support quality assurance activities by reviewing clinical data and ensuring pharmacy compliance with Good Clinical Practice (GCP) and FDA regulations.
• Collaborate with Research Administration Department Administrators and the Human Research Protection Program to follow institutional policies.
• Participate in continuing education research and training opportunities.
• Support the development of study budgets contracts grant applications and study documents for start-up and throughout the lifecycle of the study.

This job description is not designed to cover or contain a comprehensive listing of activities duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job not an exhaustive list of all possible job responsibilities tasks duties and assignments. Furthermore job duties responsibilities and activities may change at any time with or without notice.

Work Environment

• Evening hours may occasionally be required.
• Position is primarily based on-site.

Required Qualifications

Work Experience:

• Four (4) years of experience in health sciences nursing medical assisting biology or a related field. Relevant education may be substituted for experience on a year-for-year basis.
• One (1) year of clinical research experience.
• Experience with clinical research regulations (FDA GCP IRB HIPAA).

Preferred Qualifications

Certifications: Phlebotomy RD Nursing CMA/AAMA.

Work Experience:

• Clinical research experience related to diabetes nutrition physical activity or weight management.
• Experience with REDCap Epic or similar data management systems.

Skills

• Organization
• Communication
• Problem-solving
• Time-management

Required Documents:

• Resume/CV
• Cover letter

Comprehensive Benefits Package:

Coverage begins on day one for health dental and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance long-term disability insurance and various additional voluntary insurance plans are available. Paid time off including vacation and sick begins accruing upon hire plus ten paid holidays. One paid discretionary day is available after six months of employment and paid time off for bereavement jury duty military service and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available.

Required Experience:

IC

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