Clinical Research Teams
Key Features
-
- Provides free expert consultation on all aspects of protocol development and implementation
- Offers coordinator services and other study implementation support (fee for service)
- Facilitates multi-institutional research and collaboration
- Provides medical oversight as needed
Available to
- Any Harvard-affiliated clinical investigator, particularly:
- early-career investigators
- investigators who are new to clinical trials or have an investigator-initiated IND/IDE
- investigators not medically credentialed at a given institution
Clinical Research Teams are positioned in the clinical research units (CRU) at each of the four Harvard Catalyst Connector sites (BCH, BIDMC, BWH, and MGH), but can support investigators and their teams from any Harvard-affiliated institution. More information about the CRUs can be found here or at these links:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Medical Research Officer (MRO)
The Clinical Research Teams include Medical Research Officers (MROs) who are experienced senior investigators. The MROs help new and established researchers navigate the processes of finding clinical research collaborators, conducting cross-institutional research, and obtaining medical oversight for tests and procedures that require a credentialed provider. MROs can also provide guidance on study designs and grant proposals. There are four lead MROs, with one at each of the affiliated Connector sites:
Beth Israel Deaconess Medical Center – Janet Mullington, PhD
Boston Children’s Hospital – Lise Nigrovic, MD
Brigham and Women’s Hospital – Jonathan Williams, MD
Massachusetts General Hospital – Takara Stanley, MD
For investigators not medically credentialed at a given institution
A credentialed MRO located at the institution where you are interested in conducting research can provide medical oversight for some standard research tests and procedures.
For institution-credentialed investigators
A credentialed MRO located at your institution can provide limited medical oversight for your study visits while you are traveling or for other coverage needs.
Administrator/Operations
Administrators/Operations personnel provide direct consultation on protocol development as well as review an investigator’s specific needs or resource requests and provide a connection with the right supports and expertise. There are four lead administrators, one affiliated with each of the Connector sites, who oversee operations of the Clinical Research Teams:
Beth Israel Deaconess Medical Center – Michelle Beck, MBA (mbeck1@bidmc.harvard.edu)
Boston Children’s Hospital – Erica Denhoff, MPH, CCRP (Erica.Denhoff@childrens.harvard.edu)
Brigham and Women’s Hospital – Yemi Talabi-Oates, MBA (otalabi-oates@partners.org)
Massachusetts General Hospital – Lynelle Cortellini, MSc, CRA (lcortellini@mgh.harvard.edu)
Research Nursing
The clinical research nurse has in-depth knowledge of good clinical practice, federal regulations that guide research, and study design, along with clinical knowledge and judgment. Their combined training gives these nurses unique abilities and insight related to clinical trial implementation and subject protection, particularly for trials involving medically complex populations.
Research nurses at Connector sites support the development of clinical research studies for in- and outpatient settings, within and outside the clinical research centers, and in the community.
Metabolism & Nutrition Research
Experienced research dietitians (RD) and support staff provide medical and nutrition support to principal investigators. The RDs can help principal investigators develop research designs and budgets for grant applications, review study protocols, and develop comprehensive nutrition plans including implementation procedures. As a study team member, the RD educates the clinical research staff regarding the nutrition component of the study protocol, and interpretation of nutrition data. RDs can also assist with data review and manuscript preparation upon study completion.
Project Managers & Coordinators
Project managers provide direct consultation on protocol development and implementation, including data collection systems, documentation and workflow, institutional review board processes, and maintaining research protocol integrity. Project Coordinators can assist with study implementation, such as recruitment and data collection.
Recruitment Specialists
Recruitment specialists help investigators develop and implement recruitment strategies to meet recruitment metrics and can facilitate cross-institutional access. They also advise on the unique needs of special populations to increase enrollment and retention.
Navigators
Navigators help investigators and their teams to find research resources anywhere in their institutions and can also help access resources across institutions.