Clinical Research Coordinator I

University of South Florida • Tampa, FL

8d

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.

Requirements

• Bachelor's degree
• Four years of direct experience for a bachelor’s degree.
• Senate Bill 1310- The Florida Senate (https://www.flsenate.gov/Session/Bill/2023/1310) is conditional upon meeting all employment eligibility requirements in the U.S.
• SB 1310: Substitution of Work Experience for Postsecondary Education Requirements
• A public employer may include a postsecondary degree as a baseline requirement only as an alternative to the number of years of direct experience required, not to exceed:
• (a) Two years of direct experience for an associate degree;
• (b) Four years of direct experience for a bachelor’s degree;
• (c) Six years of direct experience for a master’s degree;
• (d) Seven years of direct experience for a professional degree; or
• (e) Nine years of direct experience for a doctoral degree
• Related work experience may not substitute for any required licensure, certification, or registration required for the position of employment as established by the public employer and indicated in the advertised description of the position of employment.
• Minimum Qualifications that require a high school diploma are exempt from SB 1310.

Nice To Haves

• Human subjects protections training, knowledge of the Code of Federal Regulations, GCP (Global Good Clinical Practice), and ICH (International Council for Harmonization) Guidelines as applied to clinical trials, IRB and other regulatory processes and procedures including HIPAA.
• ˜Shipping biohazard materials certification preferred.
• ˜Current certification in clinical research is preferred.
• Strong working knowledge in Microsoft Office programs and other software packages.
• Medical and research terminology, processes and procedures, phlebotomy experience, ECG training and training in other clinical procedures, and general knowledge of infection control procedures.

Responsibilities

• Clinical Study Coordination and Participant Management Coordinate a portfolio of clinical research studies under the supervision of the Principal Investigator (PI). Recruit and screen participants; obtain initial and ongoing informed consent from participants and families. Provide research-related services and interventions per study protocol. Schedule and conduct study visits and follow-ups within protocol-defined visit windows. Administer investigational products and perform protocol-defined procedures, such as: Vital signs and anthropometric measurements, Phlebotom, Electrocardiograms (ECGs), Injections and other clinical assessments as delegated and based on training/experience, Communicate participant progress and safety updates to Investigators.
• Clinical Research Center Operations Assist with the daily operations and coordination of CRC activities across multiple research studies and users. Support the development, documentation, and dissemination of CRC policies, procedures, and standard operating procedures (SOPs). Ensure adherence to quality assurance and regulatory compliance standards. Serve as a liaison between CRC and internal/external stakeholders including investigators, research staff, USF Health Care providers, volunteers, sponsors, and Contract Research Organizations (CROs).
• Specimen and Supplies Management Collect, process, and ship biological samples per study requirements. Maintain biohazardous material shipping certification and comply with all infection control and safety standards. Track and manage investigational product accountability and study supplies. Coordinate with Investigational Pharmacies and partner institutions when applicable. Fulfill registration or certification requirements for research activities conducted at affiliate sites.
• Additional Responsibilities Perform other related duties as assigned to support research goals and institutional mission.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees