Department:SOM KC Internal Medicine - Gastroenterology and Hepatology
Medicine-Gastroenterology
Position Title:Senior Clinical Research Coordinator - Internal Medicine (Gastroenterology, Hepatology & Motility)
Job Family Group: Professional Staff
Job Description Summary:The Senior Clinical Research Coordinator in The Division of Gastroenterology and Hepatology at the University of Kansas Medical Center will be responsible for independently managing and coordinating multiple, complex Phase I-IV industry-sponsored, investigator-initiated, and federally funded clinical trials. This individual will serve as the primary liaison between study sponsors, investigators, and internal research units, ensuring all activities are conducted in compliance with Good Clinical Practice (GCP), FDA regulations, and institutional policies.
Job Description:Job Duties- Clinical Trial Management:
- Manage all operational aspects of multiple concurrent clinical trials from start-up through close-out, with minimal oversight.
- Coordinate and track essential regulatory and study documentation, ensuring readiness for audits and monitoring visits.
- Create and maintain study binders, source documentation templates, and other regulatory-compliant tools.
- Participate in Site Selection Visits (SSVs), Site Initiation Visits (SIVs), Monitoring Visits, and Close-Out Visits with study sponsors and CROs.
- Facilitate protocol feasibility reviews and coordinate site qualification documentation.
- Serve as the primary liaison with sponsors, CROs, and internal departments..
- Participant Coordination & Oversight:
- Conduct prescreening, recruitment, consent, and enrollment activities in collaboration with investigators.
- Ensure protocol compliance during study visits, including specimen collection, investigational product accountability, and data documentation.
- Recognize and report adverse events, deviations, and unanticipated problems in a timely manner to the Principal Investigator for review.
- Assist the Principal Investigator with the documentation and timely reporting of adverse events, protocol deviations, and unanticipated problems to sponsors, CROs, and regulatory authorities, as required by study guidelines and at the direction of the Investigator.
- Serve as a resource for study participants, answering questions, providing support, and ensuring retention throughout study participation.
- Regulatory Affairs, Data Management, & Quality Assurance:
- Prepare and assist with IRB submissions, amendments, continuing reviews, and regulatory binders.
- Maintain up-to-date and audit-ready regulatory binders and electronic documentation systems (e.g., Complion, REDCap).
- Conduct periodic self-audits and internal quality reviews to ensure continuous adherence to protocol and SOPs.
- Lead internal audits and assist with sponsor/CRO monitoring visits, external audits, and FDA inspections.
- Ensure timely and accurate data entry into Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS), including REDCap, VELOS, and sponsor portals.
- Reconcile discrepancies between source documentation and EDC queries in collaboration with data management teams.
- Assist with development and maintenance of source documentation templates and participant tracking logs.
- Serve as a resource and mentor for clinical research coordinators and clinical research assistants.
- Assist with onboarding and training of new team members.
- Contribute to process improvement initiatives and standard operating procedures.
- Administrative & Financial Oversight:
- Contribute to team meetings, protocol reviews, and quality improvement initiatives.
- Collaborate with investigators and budget specialists to provide input during the development of the main study budget.
- Ensure all study-related information in VELOS is accurate and up to date to support timely payment processing by the Clinical Trials Finance Office (CT Finance).
- Respond to and assist CT Finance with sponsor inquiries related to invoicing, payment reconciliation, and financial reporting.
- Track participant stipends and maintain records of study-related procedures to support billing compliance.
- Represent the Gastroenterology Division in cross-departmental working groups and special projects.
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.
Required QualificationsCertifications/Licenses: One of the following:
- Certified Clinical Research Coordinator (CCRC)
- Certified Clinical Research Professional (CCRP)
Work Experience: - Eight (8) years of clinical research or related experience. Relevant education may substitute for experience on a year for year basis.
Preferred QualificationsEducation: Master's degree in relevant field.
Skills- Interpersonal skills
- Communication
Required DocumentsComprehensive 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. https://www.kumc.edu/human-resources/benefits.html
Employee Type: Regular
Time Type: Full time
Rate Type: Salary
Compensation Statement:The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.
Pay Range:$70,200.00 - $105,300.00
Minimum$70,200.00
Midpoint$87,700.00
Maximum$105,300.00
