Clinical Research Coord I

University of South Florida•Tampa, FL

10h•Onsite

About The Position

The Clinical Research Coordinator I is responsible for identifying and scheduling potential candidates for clinical research screenings. Once scheduled, the role involves generating Source Documents based on protocol and guidelines to collect data for clinical trials, adhering to the clinical trial agreement between USF and the pharmaceutical company or funding agency. The coordinator will perform all clinical trial activities and assessments in compliance with ICH and FDA regulatory guidelines, including collecting vital signs, administering surveys, and performing protocol-specific assessments. The position also requires meeting with monitors and sponsors to review data accuracy, promptly responding to emails to ensure adherence to clinical trial agreements, and assisting with stocking the clinical research center with necessary supplies. Furthermore, the coordinator will ensure all equipment and temp probes in the clinical research center and laboratory are appropriate and functional for general clinical trial use across various specialties. Finally, the role involves contributing to the regulatory binder by completing required forms to maintain compliance with ICH, GCP, and FDA guidelines.

Requirements

Ability to perform clinical trial activities and assessments as allowable per ICH and FDA regulatory guidelines
Ability to ensure compliance with ICH, GCP and FDA guidelines

Responsibilities

Call potential candidates that pre-qualify for clinical research to schedule a screening visit
Use protocol and other guidelines to generate a Source Document to gather data needed for the clinical trial
Perform all clinical trial activities and assessments, as allowable per ICH and FDA regulatory guidelines, to meet the requirements of the data collection needed per protocol
Collect vital signs
Provide surveys to the clinical trial subject
Perform assessments per the protocol and other duties as outlined by the clinical trial protocol
Meet with monitors and sponsors to review accuracy of data collected
Answer emails promptly to ensure USF adheres to clinical trial agreement executed between USF and Pharmaceutical sponsor or funding agency
Help stock the clinical research center with necessary clinical trial supplies under guidance from the clinical research teams
Ensure all equipment in the clinical research center and laboratory was appropriate for clinical trial general use for different specialties that visit the clinical research center
Ensure temp probes in the clinical research center are working properly
Contribute to the regulatory binder by providing necessary forms requested to be filled out to ensure compliance with ICH, GCP and FDA guidelines