Clinical Research Nurse (RN) - Pediatrics

Location: Various pediatric sites within Monroe County

Department: Clinical Research

About the role

Coordinates, facilitates and monitors the implementation of research protocols for the Center for Infectious Diseases and Immunology, following sponsor/protocol requirements and FDA regulations. Coordinates research-related care for pediatric patients participating in clinical trials, interacting with families and study site healthcare providers to ensure compliance with written protocols.

Responsibilities

• Demonstrates in-depth advanced knowledge of current professional nursing practice and techniques.
• Demonstrates nursing physical assessment skills.
• Works collaboratively with physicians, physician’s assistants, case managers, community health care providers, nursing staff, and leadership staff.
• Coordinates, implements, and monitors clinical trials.
• Reviews new protocols for feasibility of implementation at RGH prior to submission for approval and communicates impressions to the Research Manager, Principal Investigator, and the Medical Director of Clinical Research.
• Maintains thorough familiarity with all aspects of active study protocols; may assist with on-going inpatient trials.
• Educates nursing, pharmacy, and clerical staff about new protocols or amendment implementation and their roles.
• Participates in screening and enrollment of potential study patients/subjects in accordance with inclusion and exclusion criteria of active protocols.
• Collects and records data and submits to sponsors as required; completes screening forms, case report forms, adverse event reports, drug disposition records, and other study documents accurately and timely.
• Reconciles data queries in a timely manner by communicating with sponsors.
• Properly prepares, stores, and ships serum, plasma, and other body fluid specimens according to study protocol and sponsor requirements, including completion of accompanying laboratory requisitions.
• Maintains all study documents in a neat, orderly, and easily retrievable system.
• Assures appropriate inventories of supplies and study drugs are available for each active protocol; coordinates pharmacist participation in drug preparation and maintenance of drug disposition records.
• Communicates copies of screening logs, enrollment logs, and other documents as requested according to sponsor schedules.
• Submits adverse event reports and other IRB or sponsor-required documents during the conduct of a study.
• Participates in FDA monitoring visits and other audits.
• Demonstrates advanced skills in verbal and written communication; functions effectively as an educational resource.
• Identifies and prioritizes learning and teaching needs of patients.
• Collaborates with staff and peers.
• Performs other duties as directed.

Requirements

• Bachelor’s degree in Nursing or equivalent combination of education and experience.
• Minimum 2 years of relevant experience, preferably as an RN or Research Coordinator.
• Current New York State Registered Nursing license.

Preferred Qualifications

• Strong analytical, communication, and computer skills.
• 3 years of pediatrics experience strongly preferred.

Physical Requirements

Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects; requires frequent walking, standing, or squatting.

Pay

$86,528.00 - $118,976.00

Schedule

40 hours per week, Monday-Friday 8:00 AM - 4:30 PM (with ability to flex an hour before or after with notice).