Clinical Research Nurse
Yale Cancer Center is Connecticut's only cancer center designated as a Comprehensive Cancer Center by the National Cancer Institute (NCI) and one of only 47 in the nation. Yale Cancer Center delivers the highest quality patient-centered care, achieves breakthrough discoveries, and trains the future leaders in cancer science and medicine. There are over 190 clinical trials providing the most advanced cancer therapies at Smilow Cancer Hospital and in the 11 Care Centers located throughout the state of Connecticut. The Clinical Trials Office is in a period of rapid growth and actively recruiting.
The Clinical Research Nurse (CRN) will provide direct research nursing support for advanced cell therapy trials conducted at Yale Cancer Center. Working closely with the research staff and leadership, the CRN will assist with the necessary training and development of tools required for the conduct of clinical research. In addition, the CRN will be responsible for 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 will have direct patient contact and will be responsible for managing multiple clinical trials.
- Builds, reviews and approves accurate and complete order sets to ensure compliance with individual research protocols.
- Assesses protocols for feasibility at Smilow Cancer Hospital New Haven and Smilow Cancer Hospital Care Centers.
- Attends and participates in disease team, feasibility, site start-up and other key meetings with the responsibility to identify, analyze and disseminate appropriate information to the clinical operations staff and maintains a current understanding of priority trials for the YCC.
- 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.
- Directs the prioritization and serves as liaison to the Beacon administrator, Clinical Research Support Lab personnel, research pharmacists, Principle Investigators and research support staff as it relates to the building and approval of drug order sets and lab order templates. Directs the prioritization and approves OnCore study calendars in compliance with individual research protocols.
- Evaluates and assesses protocols in advance of protocol review meetings to determine complexity, identify risks, logistics and challenges associated with operationalizing and implementing specific trials at Smilow Cancer Hospital and its Care Centers. Collaborates with pharmacists, lab staff, CTTM(s) and others to ensure challenges and logistics are resolved prior to activating clinical research studies.
- Develops and administers tools to analyze the effectiveness of training programs and measure progress of understanding.
- Trains research staff as necessary on specific protocols and YCC standard operating procedures in conjunction and in collaboration with investigators and clinical site representatives.
- Serves as clinical resource for training and maintaining research staff use of clinical trial management systems as needed.
- Serves as clinical resource for triaging and addressing research related inquiries generated from YCC websites and professional presentations.
- Participates in the ongoing development, implementation, and evaluation of initiatives to enhance YCC clinical research services and collaborations.
- Provides patient consultation and education regarding clinical trials and provides study specific information when appropriate.
- Assists with identifying toxicities and grade, using NCI Common Toxicity Criteria. Responds to and triages calls from patients regarding symptoms.
- 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.
- Reviews Beacon order set with CRC in anticipation of upcoming participant’s clinic visit. Pends orders for routing to Investigator for approval and signature.
- Performs additional duties as required.
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.
- Active CT RN License.
Required Skill/Ability 1:
Excellent clinical, analytical and organizational skills with demonstrated research nursing ability. Well-developed ability to work as an interdisciplinary team member to accomplish organizational goals.
Required Skill/Ability 2:
Ability to interpret regulations and processes related to the conduct of clinical trials. Working knowledge of scientific concepts, research design and drug/device development process.
Required Skill/Ability 3:
Strong understanding of and ability to participate in the informed consent process.
Required Skill/Ability 4:
Strong ability to identify unanticipated problems involving risks to subjects or others, including serious adverse events.
Required Skill/Ability 5:
Proven ability to develop and participate in the delivery of training for new protocols. Excellent ability to communicate both through oral and written expression.
Preferred Education, Experience and Skills:
MSN and experience with oncology research. Strong understanding of major cancer types including disease-related symptom management, standard treatment options and treatment-related side effect management. Experience with Hematologic cancers and advanced cell therapies, a plus.
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. Please visit www.yale.edu/hronline/careers/screening/faqs.html for additional information on the background check requirements and process.
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.
Affirmative Action Statement:
Yale University considers applicants for employment without regard to, and does not discriminate on the basis of, an individual’s sex, race, color, religion, age, disability, status as a veteran, or national or ethnic origin; nor does Yale discriminate on the basis of sexual orientation or gender identity or expression. Title IX of the Education Amendments of 1972 protects people from sex discrimination in educational programs and activities at institutions that receive federal financial assistance. Questions regarding Title IX may be referred to the University’s Title IX Coordinator, at TitleIX@yale.edu, or to the U.S. Department of Education, Office for Civil Rights, 8th Floor, Five Post Office Square, Boston MA 02109-3921. Telephone: 617.289.0111, Fax: 617.289.0150, TDD: 800.877.8339, or Email: firstname.lastname@example.org.