Research Nursing and Study Coordination Support for YCCI

Participant and Clinical Interaction Resources

Research nursing and study coordination are integral parts of YCCI's research support mission. This unit comprises management personnel for inpatient and outpatient facilities; clinically-experienced research nurses for adult and pediatric studies; clinical research nurse and non-nurse coordinators, research assistants, and patient care associates. The staff members have wide ranges of clinical and research expertise to support a broad range of studies and have been cross-trained in a systematic manner to develop skills and acquire principles of patient-centered care allowing them to perform adult and pediatric protocols in many specialty and subspecialty areas of medicine, surgery, psychiatry, and pediatrics. In addition to support in the two YCCI clinical locations, research staff can be found across the campus and in the New Haven Community procuring clinical samples for a wide variety of outreach programs in such areas as drug addiction, child health and development, and obesity. 
        
This unit provides support including:

• Clinical research nursing care for studies of all complexity
• Complete clinical feasibility assessment, including review of clinical population and study procedures to determine likelihood of successful completion of protocol and satisfactory project enrollment
• Assistance with study recruitment, screening, and study eligibility
• Reviewing the protocol, informed consent form, and follow-up procedures with potential study subjects
• Ensuring adherence to protocol requirements
• Assessing subject response to therapy and evaluate for adverse events
• Reviewing laboratory data and communicate abnormal values to the primary care provider and investigator
• Assistance of study sample collections
• Assessing and document subject compliance with medications and visits
• Administering study drug therapy as needed and maintain the study drug dispensing log if the pharmacy is not involved in the study (as legally appropriate)
• Monitoring patients treated for safety and compliance

YCCI and the School of Nursing

Nursing is an integral part of YCCI's research. The Yale School of Nursing (YSN), founded in 1923, has a strong portfolio of clinical research, and despite its comparatively small size, now ranks sixth in NIH funding nationally. The school has a strong portfolio of clinical research, which is the exclusive focus of the doctoral and post-doctoral training programs. Much of the research at the YSN is community-based and focuses on developing and testing interventions to improve outcomes in chronic conditions such as obesity, diabetes, cardiovascular disease, HIV/Aids, and cancer. In addition, there are strong research programs in health disparities and acute care. In the YCCI structure, the YSN leadership and clinical and translational research resources are fully integrated into the YCCI. The expertise of the YSN investigators in psychosocial and behavioral outcome measures is a particularly important resource for other YCCI investigators. YCCI also provides tangible clinical research resources to YSN investigators.

Contact:

Outpatient Participant and Clinical Interactions Resource

• Diane Wall, RN
  Administrator for Clinical Research Services and Subject Advocacy
  2 Church Street South, Suite 415
  Phone: (203) 785-7947
  diane.wall@yale.edu

Inpatient Participant and Clinical Interactions Resource (Hospital)

• Shelley Britt, RN, BSN
  Patient Services Manager
  Yale-New Haven Hospital
  20 York St., EP 10-6, rm. 10-522
  Phone: (203) 688-4106
  shelley.britt@ynhh.org