ORGANIZATIONAL SUMMARY: The Multiple Sclerosis Division in the Department of Neurology conducts a very high volume of clinical research. With multiple investigational products in testing phases and comparison trials there are many patients being seen within the open trials. The research also seeks to understand more about the disease and its progression.
POSITION SUMMARY: This position directly reports to the Assistant Director of the [Multiple Sclerosis] division in the Department of Neurology. The Senior Research Support Specialist performs a wide variety of administrative support duties. This position participates in specialty clinic, coordinating with clinic staff and physicians to evaluate patients that might be considered for research studies. Collects, analyzes and performs quality assurance of study data. Monitors overall clinical study to insure that quality control measures are in compliance with protocol. Actively participates in research study meetings to discuss progress/status of study.
The Senior Research Support Specialist performs a wide variety of administrative support duties. This position participates in specialty clinic, coordinating with clinic staff and physicians to evaluate patients that might be consider for research studies. Collects, analyzes and performs quality assurance of study data. Monitors overall clinical study to insure that quality control measures are in compliance with protocol. Actively participates in research study meetings to discuss progress/status of study. Ensures consistent interpretation and adherence to protocols at all stages of trials by team members. Recommends changes in protocols to improve quality of data gathering or overall study.
Evaluates potential research participants with Principal Investigator; schedules screening evaluations; explains consent process; performs required screening evaluations; randomizes participants into appropriate research study. Coordinates and schedules study visit and follow-ups. Oversees or performs required procedures for each visit. Records data on each study participant for each visit according to research protocol, maintaining complete study progress notes and case report from for each visit. Reports any Adverse Event according to protocol.
Data entry for clinical trials, proofing for data entry errors, and preparing patient/participant documents for study visits, which includes development of source documents as needed. Assist with monitoring visits and attend Investigator Meetings as requested by the Assistant Director. Develop materials to communicate projects/trials to potential clients and their families and assist with the promotional materials supplied by the sponsors. Conducts patient visits and testing, including preparation of laboratory shipments and obtaining required information from study subjects during patient visits.
Oversees site inventory of supplies for the division (lab kits, premedication, patient specific supplies, office supplies)
Assist in training of new or more junior clinical research staff members.
Aids clinical staff in addressing continued patient care (calls to discuss AEs, medication questions, etc.) and may be called upon to assist during clinic hours with various providers.
This position requires a high school diploma or equivalent and six 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.
The University of South Florida Parkinson’s Disease and Movement Disorders Center is engaged in cutting edge research to improve the lives of patients in Florida and around the world. The Center is helping to unravel the causes of Parkinson’s through research into genetics, the gut microbiome, and how protein clumping causes neuronal dysfunction and cell death. Insights in these areas are critical to developing treatments to slow or stop progression of the disease. In addition, the Center is a world leader in clinical research – studies with patients to evaluate new medical and surgical therapies that show promise to combat signs and symptoms, slow progression, and hopefully one day offer a cure. The physicians and staff of the Center play a crucial role in educating health providers, patients and caregivers around the world about the disease and how to most effectively utilize the medications and surgeries currently available, and about the promise of treatments on the horizon.