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.
• 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.
• Identifies 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.

Requirements

• Associate's degree in Nursing required
• Bachelor's degree in Nursing preferred
• 1 year clinical trials experience preferred
• Or equivalent combination of education and experience

Knowledge, Skills And Abilities

• Phlebotomy skills for adult and pediatric patients and good computer skills required
• Independent and organized professional with superior interpersonal skills, sound judgment and good oral and written communication skill required

LICENSES AND CERTIFICATIONS

• RN - Registered Nurse - State Licensure and/or Compact State Licensure in NYS upon hire required