Essential Duties1. 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 ExperienceGraduate of an accredited nursing program and minimum three (3) 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 experience, or the equivalent combination of education or experience. Experience must indicate the ability to work with minimal supervision in a team environment.Weekend Hours Required?OccasionalEvening Hours Required?OccasionalDuration TypeRegularWork WeekStandard (M-F equal number of hours per day)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.Searchable Job FamilyClinical, Research Res Support, Research/SupportExternal Gateway Posting Date11-Apr-2024Total # of hours to be worked:37.5Position Focus:The Clinical Research Nurse II (CRN II) is responsible for providing research services to patients participating in clinical trials supported by the Yale Cancer Center Clinical Trials Office, while ensuring safe, compliant, efficient, and effective conduct of clinical trials.Key responsibilities include planning, tracking, and ensuring that the clinical activities for study participants are conducted in accordance with approved protocols. These activities include, but are not limited to patient screening, eligibility determination, registration and other protocol and subject milestones. The CRN II will have direct patient contact and is responsible for managing and performing the clinical and operational aspects of moderately to highly complex protocols. This position will have a particular focus on managing cellular therapy clinical trials including non-oncology populations.Required Licenses or CertificationsLicensure as Registered Nurse in the State of Connecticut or Connecticut license eligible.Preferred Education, Experience and Skills:Experience in oncology research setting and experience working with Federal Regulations and IRBs is preferred. Minimum two (2) years of clinical research nursing experience strongly preferred. Knowledge of Clinical Trials Management Systems (CTMS).Preferred Licenses or Certifications:ACRP/SOCRA (or equivalent) certification preferred. ONS certification.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.Compensation GradeAdministration & OperationsCompensation Grade ProfileManager; Program Leader (24)Bargaining UnitNone - Not included in the union (Yale Union Group)Supervisory OrganizationComprehensive Cancer Center - Clinical Trial OperationsTime TypeFull timeRequired Skill/Ability 1:Excellent clinical, analytical, and organizational skills with demonstrated research nursing ability. Proven ability to draft, proofread, and document items that are complex in nature. Proven ability to be meticulous with details. Strong computer skills required, including strong competency in Microsoft Office programs (Word, Excel, PowerPoint, etc.).Required Skill/Ability 2:Proven ability to interpret complex protocols and evaluate and assess subject's suitability for inclusion into studies, obtain informed consent, determine patient eligibility, and coordinate patient enrollment.Required Skill/Ability 3:Proven ability to multi-task, maintain confidentiality and remain focused in a fast-paced environment. Excellent time management and organizational skills.Required Skill/Ability 4:Proven ability to coordinate patient care. Strong interpersonal skills with the proven ability to communicate effectively.Required Skill/Ability 5:Knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations.NoteYale University is a tobacco-free campusCOVID-19 Vaccine RequirementThe 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:Wage RangesClick to see our Wage RangesWork ModelHybrid
