Clinical Research Nurse 1 (90740BR)

Job Description: University Job TitleClinical Research Nurse 1Bargaining UnitNone - Not included in the union (Yale Union Group)Time TypeFull timeDuration TypeRegularCompensation GradeClinical & ResearchCompensation Grade ProfileClinical Research Nurse 1 (23)Wage RangesClick here to see our Wage RangesSearchable Job FamilyClinical, Research Res Support, Research/SupportTotal # of hours to be worked:37.5Work WeekStandard (M-F equal number of hours per day)Work LocationMedical School CampusWorksite Address2 Church Street South Doctor's BuildingNew Haven, CT 06519Work ModelOn-sitePosition FocusThe clinical research nurse 1 will conduct clinical research within the Yale Y-Weight (The Yale Obesity Research Center) team on multiple human studies, assisting with coordination of studies, providing nursing services to participants enrolled in the various studies. They will ensure safe, compliant, efficient and effective conduct of clinical trials in accordance with regulatory guidance (IRB) and according to approved protocol. Interface with Principal Investigator (PI), APRN, and study team regarding all aspects of clinical trial, notify appropriate team members timely of any subject AEs, or protocol deviations and anything else relevant. Identify candidates based on inclusion/exclusion criteria, schedule, enroll, and collect medical history and various required documents/questionnaires per each study requirements. Involved in all aspects of the clinical trial and provide nursing services to patients and families in compliance with University, State and Federal guidelines. Contributes to start up activities and procedures. Maintain regulatory compliance and ensure the needs of each study are met/exceeded. Be able to communicate and work efficiently in various research databases, EPIC electronic medical record (EMR), and Outlook. Ability to work on and maintain regulatory binder for all studies.Essential Duties 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 ExperienceBachelor's of Science Degree in Nursing and three years of related demonstrated experience or an equivalent combination of education and demonstrated experience.Required Skill/Ability 1Conducts patient and research subject evaluations; administers medications and research instruments, inputs all data points electronic data capture (EDC) per sponsor/NIH study specific requirements and has proven phlebotomy ability.Required Skill/Ability 2Ability to manage and coordinate participant care throughout the study as well as all aspects of multiple clinical trials, while working within FDA and GCP guidelines.Required Skill/Ability 3Excellent oral and written communication skills, working both independently and in a team environment.Required Skill/Ability 4Ability to learn various protocol, follow guidelines, and input data correctly and timely while troubleshooting when necessary.Required Skill/Ability 5Strong organizational skills with an internal drive to continuously learn.Preferred Education, Experience And SkillsGraduate of an accredited nursing program with a Bachelor of Science degree in nursing with minimum of three years demonstrated nursing experience. Demonstrated experience in clinical research highly recommended.Required Licenses Or CertificationsLicensure as Registered Nurse in the State of Connecticut or Connecticut license eligible.Preferred Licenses Or CertificationsRegistered Nurse with current Connecticut license. BLS and AED certified.Drug ScreenNoHealth ScreeningNoBackground Check RequirementsAll 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.Posting DisclaimerThe 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 StatementUniversity 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.Inquiries concerning Yale's Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA). Note Yale University is a tobacco-free campus