Clinical Research Associate

at  University of South Florida

Dept Number/Name: 0-6123-000 / Dept Of Internal Medicine
College Division: USF Health-Morsani College of Medicine
Salary Plan: Administrative
Job Code/Title: 4728 / Clinical Research Associate
Hiring Salary/Salary Range: $45,000 - $64,000
Position Number: 00049666

ORGANIZATIONAL SUMMARY:

The Department of Internal Medicine is the largest and most complex Department in the Morsani College of Medicine with over 26 Divisions, Programs and Centers/Institutes, total human resources in excess of 1,000, and an annual all-source budget in excess of $143,000,000. The Department’s ongoing growth includes the restructure of Cardiovascular Sciences from a separate Department to a Division, support of the microbiome initiative, and the execution of clinical, research and education initiatives focused on COVID-19 and emerging infectious diseases.
The mission of the Department is to rank among the elite in the nation in the areas of education, research and patient care. The Department provides education and training for a diverse group of medical students, residents, fellows and health personnel from USF and throughout the world.
The Department’s research activities are numerous and involve both basic and clinical research activities in all subspecialties of Internal Medicine. Our NIH funding is in excess of $120 million over the past 3 years. Patient care occurs in our affiliated hospitals (including Tampa General Hospital, H Lee Moffitt Cancer Center and Research Institute, James A Haley VA Hospital, Florida Hospital) as well as our state-of-the-art ambulatory health care centers. The Department also provides healthcare support and services via contractual arrangements with many diverse organizations. The US News & World Report recent rankings of our subspecialties include Nephrology at 18, and Gastroenterology at 24 and Primary Care at 67.
The Department’s faculty represent a group of dedicated physicians that are well-recognized as leaders in all three mission areas.

POSITION SUMMARY:

The Clinical Research Coordinator (CRC) will coordinate, conduct and evaluate research related activity for clinical research projects as assigned. The primary purpose of this position is to oversee the regulatory component of the clinical trials as well as screening, enrollment and retention of study participants, to coordinate study visits, ensure quality of data collected throughout the research study, and implement procedures and activities of the assigned study protocols, according to all applicable regulations and regulatory compliance, under the direction of the Principal Investigator and the Director of Clinical Research. This position is contract funded.

SPECIAL SKILLS/TRAINING:

Strong working knowledge in Microsoft Office Programs and other software packages

Collect, process and ship research specimens. Achieve and maintain certification in biohazardous materials shipping. Ensure that infection control and safety procedures are implemented and maintained. Maintain investigational article accountability records and manage clinical supplies as required for assigned protocols. Interface with Investigational Pharmacy and Affiliate Institutions for assigned studies as applicable. Fulfill required certification or registration processes when assigned to research projects where study visit activity occurs at Affiliate Institutions.
Recruit, screen and provide research related services, interventions and evaluations per protocol for participants enrolled in clinical research studies under the direction of the Principal Investigator (PI). Provide initial and ongoing informed consent with participants and families. Schedule study visits and procedures and follow-up study visits per protocol visit windows. Administer investigational product per protocol. Perform study related procedures such as collection of vital signs and anthropometric measurements, phlebotomy, ECGs (Electrocardiography), injections and other procedures per protocol.
Prepare, process and submit regulatory documents and applications, including consent forms, to the Institutional Review Board(s) and other research review boards and committees as applicable and according to regulatory and institutional requirements. Communicate with PI and site staff, project sponsors and CROs, and review committees to ensure accuracy of regulatory documents and submissions. Track study approvals and expirations to ensure uninterrupted project approvals. Maintain regulatory files for assigned protocols. Assure all reporting requirements are met per regulatory and institutional policies.
Assist in the day to day operations of the Department of Internal Medicine including the coordination of clinical research study activities amongst all users of this shared resource. Assist with the development and dissemination of policies, procedures and site SOPs for the CRC. Ensure quality assurance of research activities conducted in the CRC. Serve as a CRC liaison with investigators, study staff, USF Health Care and research volunteers as we as research sponsors and Clinical Research Organizations (CROs).
Performs other duties as assigned.