Senior Clinical Research Coordinator - Pediatrics

Department: SOM KC Pediatrics (PEDS) ----- Behavioral Pediatrics Position Title: Senior Clinical Research Coordinator - Pediatrics Job Family Group: Professional Staff Job Description Summary: The Senior Clinical Research Coordinator (SCRC) in the Department of Pediatrics manages clinical research studies by overseeing complex activities related to the collection, documentation, and analysis of research data in accordance with regulatory requirements and institutional policies. This role ensures compliance with FDA regulations, GCP guidelines, IRB approvals, and HIPAA requirements while supporting study start-up, maintenance, and close-out activities. The SCRC collaborates with investigators, sponsors, and research staff to facilitate study conduct, contributes to study budgets and regulatory submissions, participates in quality assurance activities, and provides guidance to Clinical Research Coordinators as needed. Job Description: Job Responsibilities: Clinical Trial Management: Manage 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. Collaborate with investigators and research team to identify and address operational challenges related to study implementation, recruitment, retention, workflow efficiency, and protocol compliance. Support coordination and communication across interdisciplinary clinical, research, and administrative teams to ensure efficient study execution. Develop, maintain, and update study timelines, recruitment plans, and tracking logs to ensure deliverables are met on time and operational risks are proactively addressed. Participant Coordination & Oversight: Conduct prescreening, recruitment, consent, and enrollment activities in collaboration with clinical research coordinators/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 coordinate 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. Conduct periodic self-audits and internal quality reviews to ensure continuous adherence to protocol and SOPs. Leadership & Mentorship: Serve as a resource and mentor for junior coordinators and research assistants. Manage onboarding and training of new team members. Contribute to process improvement initiatives and standard operating procedures. Administrative & Financial Oversight: Leand and manage study team meetings, documentation and tracking of action items to ensure follow-through. Contribute to 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 Department of Pediatrics 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 Qualifications Certifications/Licenses: At least one of the following: Certified Clinical Research Coordinator (CCRC) Certified Clinical Research Professional (CCRP) Work Experience: Eight (8) years of experience in behavioral health sciences or related field. Relevant education may be substituted for experience on a year for year basis. Four (4) years of clinical research experience. Experience with clinical research regulations (FDA, GCP, IRB, HIPAA). Experience with study budgets, contracts and grant applications. Preferred Qualifications Education: Master’s degree in relevant field. Skills Computer skills Organization Communication Interpersonal skills Attention to detail Multitasking Pproject management Leadership/Mentorship Problem-solving 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. 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 The mission of the University of Kansas Medical Center is to improve lives and communities in Kansas and beyond through innovation in education, research, and health care. The University of Kansas Medical Center is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, ethnicity, ancestry, age, protected veteran or disability status, marital status, parental status, or genetic information. Under Kansas state law, certain KUMC positions are subject to disability preference. For positions subject to this requirement, KUMC will offer an interview to a person who has applied for an open position who is qualified, with or without reasonable accommodation, to meet the performance standards of the position and who has presented acceptable proof of disability. If the position you apply for is subject to the disability preference requirement, you will be asked to provide information in support of your request for disability preference when you complete the application for employment.