Clinical Research Coordinator - Internal Medicine (Diabetes Institute)

University of Kansas Medical Center•Kansas City, KS

1d•Onsite

About The Position

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.

Requirements

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).

Nice To Haves

Phlebotomy, RD, Nursing, CMA/AAMA certifications.
Clinical research experience related to diabetes, nutrition, physical activity, or weight management.
Experience with REDCap, Epic, or similar data management systems.
Organization skills
Communication skills
Problem-solving skills
Time-management skills

Responsibilities

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.
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.
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.
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.