Clinical Research Coord II - Pulmonary

About the role

This position serves as a member of the clinical research team, coordinating and completing assigned clinical research activities under the direction of the Principal Investigator and Assistant Director of Research. The incumbent will conduct clinical trials and clinical research within the Division of Pulmonary, Critical Care & Sleep Medicine, ensuring compliance with federal, state, and university policies, as well as Good Clinical Practice (GCP) guidelines and International Council for Harmonization (ICH) standards.

Responsibilities

• Support principal investigators with industry-sponsored clinical trials and internally funded research projects
• Screen, enroll, and maintain patient cohorts per protocol specifications; document informed consent and consent execution in the electronic medical record (EMR)
• Schedule and conduct study visits; ensure adherence to protocol timelines and follow-up requirements
• Manage study-related documentation, including Case Report Forms (CRFs), source documents, and regulatory files
• Utilize electronic data capture systems (OnCore, REDCap, EPIC) to maintain accurate study databases and ensure data integrity
• Communicate regularly with research sponsors, clinical monitors, and regulatory bodies to ensure compliance and resolve issues
• Process patient stipends and manage study-related expenses in accordance with sponsor budgets and institutional policies
• Conduct source document verification (SDV) visits with sponsors/monitors; address queries and deviations
• Afford assistance with internal audits, external sponsor audits, and regulatory inspections by preparing documentation and responding to findings
• Implement protocol amendments and updates; maintain current versions of protocols and related documents
• Prepare and submit institutional and regulatory documentation for study startup approval (IRB applications, CRN submissions, etc.)
• Manage Institutional Review Board (IRB), Risk Assessment Committee (RAC), and sponsor submissions related to protocol amendments, safety reports, and compliance documentation
• Maintain comprehensive regulatory files in compliance with ICH-GCP, FDA 21 CFR Part 11, and UF policies
• Respond to regulatory queries and document Corrective Action Requests (CARs) or audit findings; implement and track corrective actions
• Ensure adherence to federal, state, and sponsor-specific compliance requirements (including HIPAA, FERPA, export control)
• Archive study documents and maintain regulatory records per retention schedules post-study closeout
• Aid with development of industry-sponsored clinical trial budgets and financial proposals
• Obtain procedure cost estimates and coordinate with finance to ensure financial feasibility of studies
• Track study-related expenses and expenditures; prepare financial reconciliation reports
• Afford assistance with invoice processing and billing documentation related to study activities

Qualifications

• Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience
• 3+ years of clinical research coordination experience, preferably in pulmonary, critical care, or respiratory medicine studies
• Proficiency with clinical trial software systems (OnCore, REDCap, EPIC, Medidata) and electronic data capture platforms
• Familiarity with Good Clinical Practice (GCP) guidelines, ICH-GCP standards, and FDA regulations
• Certification in clinical research coordination (CCRC or ACRP membership preferred)
• Strong interpersonal and communication skills; ability to work effectively with patients, research teams, and external stakeholders
• Demonstrated ability to manage multiple projects and prioritize competing demands
• Ability to perform spirometry testing under supervision (or willingness to obtain certification)