Our Ability Jobs

Employer Name: Yale University

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 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: Active & unencumbered Connecticut RN License (BSN required, MSN preferred). Work Week: Standard (M-F equal number of hours per day) Posting Position Title: YCC Clinical Research Nurse 2 University Job Title: YCCI Clinical Research Nurse II Preferred Education, Experience and Skills: Active & unencumbered Connecticut RN License (BSN required, MSN preferred). Graduate 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 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.