Senior Clinical Research Coordinator Internal Medicine (Pulmonary)

Department:

SOM KC Internal Medicine - Pulmonary Critical Care and Sleep Medicine

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Pulmonary and Critical Care Medicine

Position Title:

Senior Clinical Research Coordinator - Internal Medicine (Pulmonary)

Job Family Group:

Professional Staff

Job Description Summary:

The Senior Clinical Research Coordinator in The Division of Pulmonary Critical Care and Sleep Medicine at the University of Kansas Medical Center will be responsible for independently managing and coordinating multiple complex Phase IIV 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 Outlined:

• 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.

  • 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 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 Pulmonary Critical Care and Sleep Medicine Research 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 Qualifications:

Education:

• Associates degree and six (6) years of related clinical research experience
  OR

• An equivalent combination of relevant post-secondary education and related work experience totaling at least eight (8) years

• Experience may be substituted for education on a year for year basis.

Certifications/Licenses: At least one of the following:

• Certified Clinical Research Coordinator (CCRC)

• Certified Clinical Research Professional (CCRP)

Work Experience:

• Experience with governing clinical research (CFR GCP HIPAA).

• Experience with study budgets contracts and grant applications.

• Experience with and guidelines relevant to regulatory affairs in clinical research.

Preferred Qualifications:

Education: Masters degree in relevant field.

Skills:

• Interpersonal skills.

• Communication.

• Multitasking.

• Time management.

Required Documents:

• Resume/CV

• Cover letter

Comprehensive Benefits Package: