"Clinical Research Nurse"

Overview

The Clinical Research Nurse II (CRN2) will be responsible for providing clinical and research services to patients participating in multiple projects within Yale Clinical and Community Research. The CRN2 will provide support (50%) for clinical trials enrolling women at risk for HIV in Pre-exposure prophylaxis (PrEP) treatment, The CRN2 will also provide support (50%) for a hepatitis C testing and rapid start treatment project. The project is based at Yale School of Medicine, with 4 additional sites throughout Connecticut. In each of these projects, the CRN2 participates in the design, administration, and monitoring of clinical trials and social behavioral research projects. The CRN2 conducts clinical research on study subjects by providing nursing services in compliance with relevant guidelines.

Key responsibilities

include patient recruitment and data collection, providing point of care testing and phlebotomy services, following clinical protocols for study subjects (including follow-up on orders from prescribing providers, administration of injections, physical assessments, treatment and medication adherence activities, patient education, and triaging patients). The role involves evaluating subjects for study inclusion, obtaining informed consent, coordinating patient care, managing study protocols, and collaborating with multidisciplinary researchers. The CRN2 conducts study assessments and visits using standardized data collection tools. The CRN2 develops study subject referral sources; designs and develops outreach programs.

The CRN2 will participate in developing procedures, quality assurance standards, and ensuring regulatory compliance. The CRN2 will also participate in analyzing and evaluating clinical data gathered to ensure compliance with protocol and overall clinical objective, maintaining regulatory compliance, and ensuring accurate data and biospecimen collection. Additionally, the position provides team support on research projects, ensuring meticulous data management, and assisting in the preparation of reports and publications.

The CRN2 adheres to all human subjects regulations as defined by Yale University and the federal government that pertain to research studies. The CRN2 also participates in research activities: Contributes to HIC/IRB submissions. Based on knowledge of science and research goals, collaborates with PIs on major revisions and contributes to scientific protocols. Plans and implements changes. Develops forms, clinical questionnaires and the application of research techniques; contributes to procedures manuals for clinical protocols and data collection. Responsible for the documentation of study data in EPIC and other study databases. Reviews Electronic Health Records for relevant clinical history and information. Documents clinical information as needed in the EHR (point of care test results, procedures, nursing notes). Ensures that report forms are accurately documented and completed in a timely manner at each site location. May conduct mobile testing and phlebotomy if needed. May travel to partner sites to provide staff training or attend meetings as needed.

The CRN2 delegates tasks and supervises the activities of other licensed and unlicensed care providers. May perform other duties as assigned.

Required Skills and Abilities

1. Excellent clinical, analytical, and organizational skills with demonstrated research nursing ability. Demonstrated ability to evaluate subject suitability, coordinate patient enrollment, and obtain informed consent.
2. Proven experience conducting and supporting all phases of clinical research, including recruitment, data management, and analysis. Previous experience working on large-scale research studies or multi-site projects. Proficiency in using electronic medical records and research databases.
3. Proven ability to multi-task, maintain confidentiality and remain focused in a fast-paced environment. Excellent time management and organizational skills. Strong organizational and time management skills, with the ability to manage multiple research studies simultaneously.
4. Excellent written and verbal communication skills with strong attention to detail, for interacting with study participants, medical teams, and regulatory agencies.
5. Proficiency in Microsoft Office Suite, and experience with electronic data collection tools (REDCap, Qualtrics) and electronic health records (EPIC).

Preferred Skills and Abilities

At least 3 years of experience as a Registered Nurse. Demonstrated knowledge of Connecticut community resources. Proficiency in using electronic medical records and research databases. Experience with phlebotomy and wound care for patients who use injection drugs. Experience with people with serious mental illness, homelessness, substance use disorder, and people with HIV and/or hepatitis C risk or in treatment.

Required Certifications

Registered Nurse licensed in CT. Certified in Phlebotomy.

Principal Responsibilities

1. Evaluates and assesses subject’s suitability for inclusion in studies; develops and modifies procedures according to study findings; recommends changes to the study protocol to coincide with study goals and objectives.
2. Develops and implements procedures and data quality assurance standards for safety monitoring components of studies.
3. Contributes to designing activities, policies and procedures to improve day to day efficiency of the recruitment and assessment components of the study and to ensure that staff members perform activities within established research protocol.
4. Arranges patient enrollment, determines patient eligibility and obtains informed consent.
5. Develops study subject referral sources; designs and develops outreach programs.
6. Collaborates with multidisciplinary researchers to coordinate research programs that integrate new advances in clinical trials.
7. Delegates tasks and supervises the activities of other licensed and unlicensed care providers.
8. May perform other duties as assigned.

Required Education and Experience

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

Required License(s) or Certification(s)

Licensure as Registered Nurse in the State of Connecticut or Connecticut license eligible.