Senior Clinical Research Coordinator - Pediatrics
Senior Clinical Research Coordinator - Pediatrics
Department: SOM KC Pediatrics (PEDS) - Behavioral Pediatrics
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.
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.
- 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.
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
- 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.
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. 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
- Project management
- Leadership/Mentorship
- Problem-solving
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