Clinical Research Coord II - Pulmonary

University of Florida•Gainesville, FL

2d•$53,000 - $69,700

About The Position

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. This role requires strong organizational, problem-solving, communication, and regulatory compliance skills, with the ability to manage multiple projects simultaneously while maintaining accuracy and attention to detail.

Requirements

Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
Strong organizational, problem-solving, communication, and regulatory compliance skills
Ability to manage multiple projects simultaneously while maintaining accuracy and attention to detail.

Nice To Haves

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)

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
Assist 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
Ensure informed consent documents (ICF) are properly executed, documented, and filed; coordinate updates with IRB approval
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
Assist 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
Assist with invoice processing and billing documentation related to study activities.
Attend and participate in research staff meetings, trainings, and professional development opportunities
Provide general support to the clinical research team and Division operations as assigned
Perform ad hoc assignments as directed by the Principal Investigator and Assistant Director of Research.