Research Support Specialist/Allergy Immunology

From a clinical research standpoint, 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 participation in federal, investigator, 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 management of the divisions major biorepository while maintaining other laboratory functions and safety. The division of Allergy Immunology and Rheumatology is located in the Children's Research Institute in St Petersburg, FL. The Allergy, Immunology and Rheumatology clinic is located in the outpatient care center at All Children's Hospital in St. Petersburg, FL. It consists of 5 clinical faculty and 3 research faculty plus research and clinical support staff and a fellowship training program. It supports five faculty members, three full time technicians, and also supports three core laboratories. This position will report to the division chair. **This position is Time-Limited. This position requires a level II background check.** ### Responsibilities 30 %: Coordinates site visits and collects/manages patient and lab data for sponsored, and investigator-initiated studies. Monitors clinical studies and communicates status to Pl and other personnel involved in the study. Assist in patient pre -screening and organization of recruitment. Reviews protocol enrollment forms and confirms patient eligibility prior to patient registration, including obtaining all necessary informed consent forms. Participates in follow-up and assists in care of patient complications. May assist with clerical and patient care as needed; assist with patient visit check-in (obtaining vitals), oversee medications and treatments. Responsible for coordinating, scheduling, and ensuring proper utilization of laboratory and other research facilities. 25%: Collects, organizes, and analyzes research samples/data from all trials and studies in the division. Processes samples for both investigators initiated and clinical research trials. Main processing lab technician for patients’ samples regarding the biorepository specimen. Develops and maintains research databases for analysis. As new studies are implemented, determination of the most effective methods for locating, identifying, screening, and accepting subjects into new studies according to protocols. Assures that safety and infectious control measures are implemented. Ensure data quality control. Oversees data collection from remote study sites. 20%: Prepares initial applications for IRB submission, modification requests, and continuing reviews. Prepares and maintains regulatory and compliance documents. Interprets and applies rules and regulations pertaining to clinical research to ensure compliance (i.e. Code of Federal Regulations) Interprets and applies requirements and standards as set forth by the National Institutes of Health and FDA. Recommends changes in procedures in order to locate, accept, and track clients. Actively participates in meetings pertaining to protocols to ensure consistent interpretation and adherence to protocols at all stages of study. Evaluates protocol study forms and reviews records for completeness, accuracy, and compliance in preparation for external audits. 15%: From Clinical standpoint, oversees and organizes investigational research visits on a case-by-case basis. Ensures patient visit occurs, along with proper sample collection and shipment to collaborating institution. Handles the sample collection for inpatient study subjects. Works with primary care team to ensure safe and proper collection. 10%: Coordinates the establishment of collaborative research contracts and agreements for the division and individual studies (MTAs, CTAs, DTAs, CRAs etc.) Organizes clinical research stipend payment a…