Research Nurse Coordinator

• Participates in ongoing research studies such as phase 1-3 vaccine studies or studies in therapeutic agents in both adults and pediatric populations
• 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

• Associate's degree in Nursing required
• 1 year clinical trials experience preferred
• Phlebotomy skills for adult and pediatric patients required
• Good computer skills required
• Independent and organized professional with superior interpersonal skills, sound judgment and good oral and written communication skill required
• RN - Registered Nurse - State Licensure and/or Compact State Licensure in NYS upon hire required

Bachelor's degree in Nursing preferred