Clinical Research Registered Nurse - Pediatrics

Job Title: Clinical Research Registered Nurse - Pediatrics

Location: Bay Creek Pediatrics and Finger Lakes Medical Associates Geneva (as needed)

Department: Clinical Research

Hours Per Week: 40

Schedule: Monday-Friday 8-4:30pm

SUMMARY:

Coordinates, facilitates and monitors the implementation of research protocols being conducted by the Center for Infectious Diseases and Immunology, of the Rochester General Hospital Research Institute, 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, ensuring 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 their impression to the​
• Research Manager, Principal Investigator and the Medical Director of Clinical Research.
• Maintains thorough familiarity with all aspects of active study protocols being conducted by assigned department may also be called upon to assist with on-going inpatient trials.
• Educates nursing, pharmacy and clerical staff about new protocols or amendment implementation and their roles in the implementation.
• Participates in screening and enrollment of potential study patients/subjects in accordance with the 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 in an accurate and timely manner.
• 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 that appropriate inventories of supplies and study drugs are available for each active protocol. Coordinates the participation of pharmacists in drug preparation and maintenance of drug disposition records according to protocol requirements.
• Communicates copies of screening logs, enrollment logs, and other documents as requested according to the schedule established by each sponsor or other third party.
• Submits adverse event reports and other IRB or sponsor required documents during the conduct of a study.
• Participates in any FDA monitoring visits.
• Participates in other audits.
• Demonstrates advanced skills in verbal and written communication, and functions effectively as educational resource.
• Identifies and prioritizes learning and teaching needs of patients.
• Collaborates with staff and peers.
• Performs other duties as directed.

REQUIRED QUAILFICATIONS

• 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
• Pediatrics experience preferred.
• Passionate about research discovery.
• Intellectually curious, enthusiastic learner.
• Self-starter, organized and able to multitask.
• Experience working with infant and toddler patients and their families
• Good language and communication skills.
• Familiarity with productivity software such as Microsoft Office or Google Suite.
• Internet and email proficiency.
• Understanding of computer security and privacy.

EDUCATION:

LICENSES /