YCCI Clinical Research Nurse II

Position Focus :

The Clinical Research Nurse II for the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) will work under the direction of the CNRU Director and in collaboration with the CNRU inpatient team to educate staff on various research activities and ensure that the clinical activities for study participants are conducted in accordance with approved protocols.

Responsibilities include develops and implements procedures and data quality assurance standards for safety monitoring components of studies.

Contributes to designing activities, policies, and procedures to improve day to day efficiency of research activities on the CNRU, assessment components of various studies, and to ensure that the CNRU nurses and mental health assistants properly perform activities within established research protocol.

Delegates tasks and supervises the activities of other licensed and unlicensed care providers. With limited supervision and oversight from the Director of the CNRU, serves as the clinical research point person for all study protocols, both inpatient & outpatient.

Essential Duties include evaluates and assesses research protocols and develops and modifies procedures according to individual study needs.

Recommends changes to the study protocol to coincide with study goals, objectives, and available resources. Perform nursing duties for specific research protocols, in collaboration with CNRU nursing staff, including assessment, vital signs, phlebotomy, EKGs, placement and management of IVs, management of clinical records, and related tasks.

Develops and implements procedures, flowsheets, and data quality assurance standards for safety monitoring components of studies as related to nursing care.

Contributes to designing unit policies and procedures to improve day to day efficiency of the CNRU and to ensure that nursing staff perform assigned activities within established research protocol.

Collaborates with multidisciplinary researchers to coordinate research studies on the CNRU that integrate new advances in clinical trials.

Delegates tasks and supervises the activities of other licensed and unlicensed care providers. Educates and trains CNRU nursing staff on nursing-specific responsibilities and tasks related to each individual protocol.

Collaborates with CNRU nursing leadership to schedule and maintain all research activities on the CNRU. Collaborates with CNRU Program Manager and Lab Manager to maintain service contracts for lab equipment, including cryofreezer and centrifuges, and train research staff in proper use of CNRU lab equipment.

Essential Duties

1. Coordinates, implements, and evaluates all aspects of clinical trial conduct including study initiation, execution / maintenance, completion, and administration for moderately to highly complex protocols.

2. Assists study feasibility reviews. 3. Adheres to study protocol, maintains accurate documentation, recruits study participants, and ensures regulatory and protocol requirements and guidelines are met per ICH / GCP, federal regulation, and institutional and sponsor requirements.

4. Identifies instances of noncompliance and deviations from protocol and reports noncompliance and deviations to the appropriate parties.

5. Builds, reviews, and approves accurate and complete order sets to ensure compliance with individual research protocols.

Reviews Beacon order set with CRC in anticipation of upcoming participant’s clinic visit. Pends orders for routing to Investigator for approval and signature.

6. Assists in ensuring Principal Investigator oversight by providing updates on protocol issues, obtaining signatures and clinical significance on lab reports, ECGs, adverse events, and other documents as required.

7. Develops and participates in the delivery of training for new protocols, including the creation of training materials, protocol-specific tool kit, nursing in-service presentations and others as required by specific protocols.

Determines the appropriate training delivery mechanism, timing, and frequency. 8. Performs direct patient care (clinical and non-clinical assessments) including, but not limited to electrocardiograms and administration of research instruments per study protocol requirements.

9. Maintains the integrity of the clinical research study by striving to advocate for patients and families. Serves as clinical resource for triaging and addressing research related inquiries generated from YCC websites and professional presentations.

10. Provides patient education and medical information to study participants and families to ensure understanding of proper medication dosage, administration, and side effects, when appropriate.

11. Serves as front line medical person in interpreting protocol to medical and nursing staff, particularly concerning dose medications and safety issues related to the administration of the study drug or treatment.

12. Participates in monitoring visits, and external audits (e.g., sponsor, FDA) to ensure smooth and positive process and outcome.

13. Tracks and reports adverse events, serious adverse events, protocol waivers, deviations, and violations. 14. Performs other duties as assigned.

Required Education and Experience

Graduate of an accredited nursing program and minimum three years of related nursing experience in a hospital, clinic, or similar health care setting required or 3 years of clinical research nurse experience, or equivalent combined proven experience, or the equivalent combination of education or demonstrated experience.

Demonstrated experience must indicate the ability to work with minimal supervision in a team environment.

Required Skill / Ability 1 :

Demonstrated clinical and analytical skills and experience and patient care experience with strong knowledge of current psychiatric diagnoses, medications, and treatments.

Required Skill / Ability 2 :

Ability to schedule and coordinate research activities as well as work with on an interdisciplinary team to develop action items and other means to keep projects moving along according to timeline.

Required Skill / Ability 3 :

Ability to create and follow research project related supporting documents including nursing flowsheets and standard operating procedures.

Required Skill / Ability 4 :

Ability to perform general phlebotomy, as well as place, manage, and troubleshoot IVs and perform ECG.

Required Skill / Ability 5 :

Ability and willingness to educate and train both nursing and research staff in clinical skills and tasks as appropriate.

Knowledge of research protocols an ability to review all proposed protocols for accuracy and feasibility to conduct each protocol on the CNRU.

Preferred Education, Experience and Skills :

Active & unencumbered Connecticut RN License (BSN required, MSN preferred).

Required Licenses or Certifications

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

Weekend Hours Required?

Occasional

Evening Hours Required?

Occasional

Drug Screen

Health Screening

Background Check Requirements

All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements.

All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website.

COVID-19 Vaccine Requirement

The University maintains policies pertaining to COVID-19. All faculty, staff, students, and trainees are required to comply with these policies, which may be found here :

Posting Disclaimer

The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the particular position.

Employees will be assigned specific job-related duties through their hiring departments.

EEO Statement :

University policy is committed to affirmative action under law in employment of women, minority group members, individuals with disabilities, and protected veterans.

Additionally, in accordance with Yale’s Policy Against Discrimination and Harassment, and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual’s sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran.