Senior Clinical Research Coordinator - Pediatrics

University of Kansas Medical Center•Kansas City, MO

1d•$70,200 - $105,300•Onsite

About The Position

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.

Requirements

Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP)
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.
Computer skills
Organization
Communication
Interpersonal skills
Attention to detail
Multitasking
Project management
Leadership/Mentorship
Problem-solving

Nice To Haves

Master’s degree in relevant field.

Responsibilities

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.
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.
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.
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.
Lead 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.

Benefits

health, dental, and vision insurance
health expense accounts with generous employer contributions
Employer-paid life insurance
long-term disability insurance
various additional voluntary insurance plans
Paid time off, including vacation and sick
ten paid holidays
One paid discretionary day after six months of employment
paid time off for bereavement, jury duty, military service, and parental leave after 12 months of employment
A retirement program with a generous employer contribution
additional voluntary retirement programs (457 or 403b)