Research Nursing - Information for Investigators

Research nursing is a growing specialty practice within nursing, divided into two principal clinical research nursing roles:

Clinical Research Nurses (CRN):  Clinical staff nurses with a central focus on care of research participants. They support study implementation within the context of a care delivery setting, such as research units in Clinical Translational Science Award sites or specialty care programs with a clinical research focus.

Research Nurse Coordinators (RNC):   Nurses primarily responsible for study coordination and data management, with a central focus on managing subject recruitment and integrity, and compliance with regulatory requirements and reporting. These nurses are often hired by a PI to help implement and coordinate a trial or a small group of research studies.

Research nurses in institutions that participate in Harvard Catalyst support the conduct of clinical research studies in in- and outpatient settings, within and outside the clinical research centers, and in the community.

The research center nursing staff is specially trained to provide the following services:

• Assist investigators with the planning and implementation of clinical research protocols; develop data collection sheets and MD orders.
• Perform clinical assessments, observations, and treatments.
• Provide patient care while adhering to the detail of research protocols.
• Collect and maintain the integrity of research specimens.
• Process research specimens using basic techniques.
• Advocate for subjects and their families who are volunteering to participate in research.
• Monitor, identify, and report adverse events.
• Research nurse coordinators can assist with study coordination either alone or in concert with study coordinators.

Guidance for Delegation of Responsibilities in a Clinical Study

Investigators often have questions about which study-related responsibilities can and should be delegated to a study coordinator rather than a licensed personnel, such as a research nurse. In 2009, the Food and Drug Administration (FDA) released a document intended to provide such guidance in the contest of FDA-regulated research studies.

Research Nursing Contacts at the Harvard Catalyst Clinical Research Center Sites:

Should you wish to speak with a nurse manager to discuss the nursing requirements for your study, please contact the nurse manager for your institution's  Harvard Catalyst Clinical Research Center site:

Beth Israel Deaconess Medical Center
Linda Godfrey-Bailey, MSN, ACNS, BC
781-626-2426
E-mail

Brigham and Women's Hospital
Sheila Driscoll, MSN, RN
617-732-7764
E-mail

Children's Hospital Boston
Cindy Williams, MSN, RN
857-218-4383
E-mail

Massachusetts General Hospital
Kathy Hall, MSN, RN, NP
617-726-3295
E-mail

Massachusetts Institute of Technology
Catherine Ricciardi, BSN, RN
617-253-6332
E-mail