RN, Research

Responsibilities

Participates in ongoing research studies such as phase 1-3 vaccine studies or studies in therapeutic agents in both adults and pediatric populations. Works independently, utilizing strong interpersonal skills in communicating with adult subjects and their families, their health care providers, and a willingness to develop the logistics of subject enrollment, persistence and flexibility in assuring on-going subject cooperation and good data collection skills. On occasion, requires travel to private medical offices and Urgent Care facilities in the Rochester area to enroll potential subjects and obtaining required samples. ESSENTIAL FUNCTIONS Conducts unstructured interviews with subjects and families as required by protocol. Performs clinical research related procedures, such as blood draws, nasal washes, and swabs. Measures, records, and reports indicators of patient health status. Performs more specialized tasks, such as pediatric blood draws and ECG. Evaluates subjects for local or systemic reactions to determine adverse events to study medication or vaccine. Discusses potential adverse events and SAEs with subjects and participates in grade of events. Participates in the reporting of subject serious adverse events (SAE) and filing of these in a timely manner to sponsors and IRBs. Identification of subject pool, eligibility screening in clinic settings, and/or telephone screens. Completes medical history review. Obtains informed consent and proceeds with enrollment procedures. Answers patient questions to ensure understanding of the clinical study and their involvement. Participates in performing all protocol required study procedures on subjects, including but are not limited to, nasal swabs, nasal washes, venipuncture, and urine collection. Reviews and interprets study guidelines for next steps necessary for the processing and/or shipment of samples which may require home visits and visits conducted under stringent precautions. Tracks and prepares requests for payments to subjects. Attends and participates in study team meetings, monthly research group meetings, and participate in unique sponsor-required training prior to study start. Establishes and maintains relationships with sponsor representatives to ensure regulatory compliance and quality assurance/control. Oversees Quality Assurance and Control to optimize ID site study performance. Makes recommendations and implements changes to improve site study performance, including but is not limited to, source document verification and ensuring its accuracy and compatibility with case report form information. Performs QA of charts to ensure subjects meet all of the eligibility requirements for study participation relating to the study. Ensures procedures are performed per protocol and confirms that no deviations from protocol have occurred. Ensures all source document information is completed accurately and includes all information required by the study sponsor. Inventories study supplies, restocks exam rooms, and organizes supplies and charts for each individual study protocol. Assists with data entry, filing, mailings, source document development, and compiling study summary data as needed. Other duties as assigned.