Research Support Specialist Genetics - Temporary

The primary purpose of this position is to recruit and retain study subjects while coordinating their visits and managing data gathered as a result of their investigator participation, initiated, and sponsored research projects, all while staying compliant with FDA and IRB guidelines and regulations. This position also involves a laboratory aspect. Sample retrieving, processing, and shipping for investigator-led and sponsored studies.

The division's primary biorepository management while maintaining other laboratory functions and safety. Monitor compliance with study procedures with Federal, State, and University regulations. Ensures that documents such as eligibility forms and informed consent are appropriately gathered and maintained, HIPAA regulations are followed, and that infection control and safety procedures are implemented. Prepares and maintains regulatory and compliance documents such as IRB applications. Collects and analyzes data from clinical trials or other medical screenings.

This position is grant funded.

This position requires a level II background check.

40% Clinical Research Coordination & Study Management

• 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.

25% Participant Recruitment & Clinical Research Activities

• 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 (Pl).
• 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.

20% Regulatory Compliance & Documentation

• 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 Pl 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.

10% Research Operations & Quality Assurance

• 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).

5% Additional Responsibilities

Performs other duties as assigned.

Minimum Qualifications:

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.

Preferred Qualifications:

Bachelor's degree in a field directly related to the program’s responsibilities and one year of professional experience; or Master’s degree in an area of specialization appropriate for the program.

Experience in Genetics and Metabolism Specific Clinical Research. Medical and research terminology, health care setting processes and procedures. ECG training and training in other clinical procedures, and general knowledge of infection control procedures.

Exposure to research.

Strong working knowledge of Microsoft Office programs and other software packages.

Senate Bill 1310- The Florida Senate () 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.