Clinical Research Coordinator I

University of South Florida•Tampa, FL

About The Position

The candidate would be responsible for calling potential candidates that pre-qualify for clinical research to schedule a screening visit. Once scheduled, the candidate duties would include using protocol and other guidelines to generate a Source Document to gather data needed for the clinical trial, per the clinical trial agreement executed between USF and the pharmaceutical company or funding agency. The candidate's duties would include performing 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. This includes but is not limited to, collecting vital signs, providing surveys to the clinical trial subject, performing assessments per the protocol and other duties as outlined by the clinical trial protocol. Candidate would 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. In addition, candidate would help stock the clinical research center with necessary clinical trial supplies under guidance from the clinical research teams. Candidate would 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. As well, candidate would ensure temp probes in the clinical research center are working properly. Candidate would contribute to the regulatory binder by providing necessary forms requested to be filled out to ensure compliance with ICH, GCP and FDA guidelines.

Responsibilities

Calling potential candidates that pre-qualify for clinical research to schedule a screening visit
Using protocol and other guidelines to generate a Source Document to gather data needed for the clinical trial
Performing 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
Collecting vital signs
Providing surveys to the clinical trial subject
Performing assessments per the protocol and other duties as outlined by the clinical trial protocol
Meeting with monitors and sponsors to review accuracy of data collected
Answering emails promptly to ensure USF adheres to clinical trial agreement executed between USF and Pharmaceutical sponsor or funding agency
Helping stock the clinical research center with necessary clinical trial supplies under guidance from the clinical research teams
Ensuring 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
Ensuring temp probes in the clinical research center are working properly
Contributing to the regulatory binder by providing necessary forms requested to be filled out to ensure compliance with ICH, GCP and FDA guidelines.