Clinical Research Nurse LPN

Description

Job Title: Clinical Research Nurse - LPN

Department: RGH Research Institute

Location: Various Pediatric Clinical Sites

Hours Per Week: 40

Schedule: M-F Days

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.

· Passionate about research discovery.

· Intellectually curious, enthusiastic learner.

· Self starter, organized and able to multitask.

· Experience monitoring clinical trials.

· 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.

· Familiarity with FDA regulations for clinical trials.

· Familiarity with Electronic Case Report Forms such as CRIO or REDCap.

· Internet and email proficiency.

· Understanding of computer security and privacy.

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 and , Principal Investigatorr 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.

Minimum Qualifications:

· Graduate from an accredited School of Practical Nursing

· Strong analytical, communication, and computer skills

· Ability to interact well with pediatric patients and patients families.

· Pediatrics and Clinical Trial experience preferred.

· Required Licensure/Certification Skills:

· Current New York Nursing license.

· Valid NYS Driver's license and reliable transportation.

PHYSICAL REQUIREMENTS: M - 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.

The listed base pay range is a good faith representation of current potential base pay for successful applicants. It may be modified in the future. Pay is determined by factors including experience, clinical licensure date, relevant qualifications, specialty, internal equity, location, and contracts.