Research Support Specialist

University of South Florida•Tampa, FL

About The Position

The Research Support Specialist will coordinate, conduct and evaluate research related activity for translational and clinical research projects as assigned. The main responsibility of the position is to oversee the screening, enrollment, and retention of study participants, perform clinical and imaging data collection, ensure quality of data collected throughout the research study, and implement the procedures and activities of the assigned study protocols, according to all applicable regulations and regulatory compliance, under the direction of the Principal Investigator (PI). The primary focus of research will be in spinal conditions such as scoliosis and spondylolisthesis and minimally invasive spinal procedures.

Requirements

This position requires a high school diploma or equivalent and four years of experience in office or administrative support or in research support.
College education may be substituted for the required experience on a year for year basis.
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.

Responsibilities

Provide research-related services, interventions and evaluations for participants enrolled in translational clinical research studies under the direction of the Principal Investigator (PI).
Provide initial and ongoing informed consent with participants and families.
Perform clinical and imaging data collection.
Communicate participant status to Investigator and research team as well as other entities as required.
Maintain research progress notes and source documents to record data for each study participant in accordance with the research protocol.
Monitor participant's unexpected and adverse events, laboratory, radiology, and other procedure test results and report to Investigator, sponsor and IRB (Institutional Review Board) as appropriate.
Monitor clinical study activity to ensure compliance with the protocol and all applicable regulations, including HIPAA (Health Insurance Portability and Accountability Act) regulations.
Prepare and submit documents to the Institutional Review Board(s) and other research review boards and committees as applicable and according to regulatory and institutional requirements.
Compile and maintain regulatory files for assigned protocols.
Coordinate, prepare for and participate in monitoring visits, audits and inspections.
Complete and maintain necessary training to stay abreast of current regulatory guidelines.
Participate in the planning and execution of education and training activities, specific to assigned studies and to general clinical research educational activities.
Serve as a resource for internal and external customers and members in regard to clinical research processes, developments and trends in the field as well as referrals to specific clinical research studies as applicable.
Performs other duties as assigned.