Translational Navigation Teams
Key Features
- Provides expert consultation on all aspects of protocol development and implementation
- Facilitates multi-institutional research and collaboration
- Provides medical oversight as needed
- Enables clinical research by non-clinicians
Available to
- Any Harvard-affiliated clinical investigator, particularly:
- junior faculty, fellows, allied health professionals, and medical and graduate students
- any investigator who is new to clinical trials, who has an investigator-initiated IND/IDE, or who will be working with special populations
- investigators not medically credentialed at a given institution
Medical Research Officer (MRO)
The Translational Navigation Teams are led by a Medical Research Officer (MRO). The MROs also help new and established researchers to navigate the process of finding clinical research collaborators, conducting cross-institutional research, and obtaining medical oversight for tests and procedures that require a credentialed provider. There are four lead MROs, one affiliated with each of the Harvard Catalyst 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
The MRO located at the institution where you are interested in conducting research can provide medical oversight for some standard research tests and procedures such as:
- ‘Minimal risk’ blood draw: A collection of blood up to 200 cc drawn at one time by venipuncture from healthy, non-pregnant adults who weigh at least 110 pounds. For healthy children, the volume of blood collection by venipuncture, fingerstick, or heelstick will be determined based on the age and weight of the child.
- Routine questionnaires: Typical clinical/research instruments and ones where subject answers are unlikely to result in the need for immediate medical attention.
For institution-credentialed investigators
The 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 Navigator
Administrators/Operations Navigators 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 Harvard Catalyst Connector sites:
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 practices, 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 in institutions that participate in Harvard Catalyst support the development of clinical research studies in 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 & 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
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.
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.