"Clinical Research Nurse 1"

Overview

The clinical research nurse will work with Hemophilia Treatment Center (HTC) staff to support clinical and translational research projects. This work will include providing clinical, research, and data management support related to the regulatory submission, collection, and reporting of study-related clinical data for HTC protocols. The research nurse will actively participate in patient screening, eligibility determination, obtaining informed consent, and other protocol and subject milestones for adults and children participating in research studies. Under the guidance of program leadership, they will develop independent judgment and high-level decision-making, as well as extract, record, and disseminate treatment-related information for regular reporting and monitoring by the research team and study sponsors.

Required Skills and Abilities

1. Licensure as a Registered Nurse in the State of Connecticut or eligibility for Connecticut licensure.
2. Strong clinical skills, including patient assessment, phlebotomy, IV insertion, and medication administration.
3. Excellent communication and interpersonal skills for effective interaction with study participants, medical staff, and research teams.
4. Proven ability to work independently and as part of a team, with strong organizational and multitasking abilities.
5. Proficiency in data collection, electronic medical record systems, and compliance with regulatory requirements.

Preferred Skills and Abilities

1. Proven expertise or ability to acquire expertise in working in clinical trials setting and ability to make high-level decisions related to clinical research; working knowledge of or indication of clear capacity to become fluent in hematology terminology.
2. Proven expertise and or ability to develop expertise with data abstraction and clinical/research analysis; proven ability to multi-task, maintain confidentiality and manage abroad variety of duties and shifting priorities in a changing environment and to be organized and meticulous with details.
3. The research nurse will display excellent interpersonal skills with the proven ability to communicate effectively, and have the ability to work as part of a multi-disciplinary team and when needed function in a self-motivated and independent manner. Ability to work collegially with study sponsor personnel is required.
4. Strong computer skills required, including strong competency in electronic medical records databases, Microsoft Office programs (Word, Excel, PowerPoint, etc.).
5. Professional appearance and manner, as well as excellent attendance record, time management with Superior verbal and written communication skills.

Principal Responsibilities

1. Identifies, assesses eligibility, enrolls, and collects accurate medical and demographic history on research subjects for a variety of studies; obtains and explains written consent for subject participation.
2. Provides direct clinical services to subjects; observes subjects and notifies clinicians to any medical/emotional change.
3. Contributes to protocol development, submission, and renewal by collecting written materials and writing procedural documents; ensures ongoing compliance with institutional review board (IRB) policies by monitoring changes in IRB policies related to human specimens and informing the research team of such changes.
4. Conducts patient and research subject evaluations; administers medications and research instruments, and presents data.
5. Reviews, codes and contributes in the entering of all collected patient data to assure completeness and accuracy.
6. Ensures regulatory compliance by maintaining clinical and nursing records to meet the needs of various protocols.
7. Maintains the integrity of the clinical research study by striving to advocate for patients.
8. May perform other duties as assigned.

Required Education and Experience

Bachelor’s of Science Degree in Nursing and three years of related experience or an equivalent combination of education and experience.

Salary Range

$65,000.00 - $101,000.00

Location

New Haven, Connecticut