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Our Services

The goal of the newly created Clinical Research Core is to provide shared services for investigators within the Department in providing clinical trial proposal development, clinical trial staffing, regulatory guidance, scientific writing, data analysis and fiscal management oversight.

Dr. David McManus (Program Director and Chair of Medicine) has extensive expertise and success in acquiring new clinical trial and research funding. The Clinical Research Core is a one stop shop for investigators to have access to shared services.

Dr. Kate Fitzgerald (Program Co-Director) has extensive expertise and success in a rather robust grant research portfolio.  Dr. Fitzgerald will guide investigators in getting the appropriate staff within the Clinical Research Core for acquiring help in scientific writing, IRB approval, and laboratory startup and collection of samples. 

  • The first step is, guiding the idea generator, turning one's idea into an actual and viable research protocol.
  • Next, a scientific mentor will work with the novice investigator in developing the idea, into a research study that can generate enough data to answer the scientific question(s) posed by the investigator. The mentor should also be aware of the navigation process within the home institution, to be able to not just discuss the research steps with the investigator but can either guide the investigator or guide the research team member supporting the investigator.
  • Executing a clinical study is complex, the Director/Associate Director will help guide the new investigator in avoiding, or minimizing, these pitfalls through consultation and assistance with determining the best approach for study design as well as IRB or other institutional approval processes. The scientific mentor will also serve as a guide to the investigator during the conduct of the clinical trial and assist during data analysis, manuscript production, and grant submission.

Supervision and mentoring of research staff as needed:

Albert Sherman Lab.jpegIn today's research climate, the clinical investigator is often responsible to oversee study process, manage the health care for the study subjects/patients, and manage study staff operations (i.e., study duties, training, and time management). Most principal investigators are given 10%–25% of their time for all of these activities, making it difficult to manage priorities. The Department of Medicine, Clinical Research Core has a Program Manager/Supervisor, who can serve in this capacity to oversee and guide the assigned research staff and also to assist the researcher in navigating throughout the research regulatory process.

Protocol development/regulatory:

Protocals.jpgShared Services will provide and assist investigators during the regulatory process for approval and activation of the research study as needed. This can include the development of the protocol details, budgets in On Core, setting up and negotiating contracts, liaison with the central clinical translational research office and IRB approval. The evolution of research regulation is such that even experienced investigators can be troubled by budget overruns, compliance issues, and appropriate personnel oversight.

The resource of protocol development and regulatory compliance shared services contact/team will be provided by the Department of Medicine Clinical Research Core in an ongoing basis before, during and after a trial is active.

Study coordination/data management:

Data.jpgCoordinator services are an important role order to execute IRB approved protocols and overseeing the operational aspects of a clinical study (i.e., compliance and patient recruitment). Many protocols may call for coordinator (10%–100%) for the duration of a study (a few days to a few years). This makes hiring and maintaining adequate staffing difficult at best, unless research funding is continuous over long periods of time. The Department of Medicine, Clinical Research Core, can help with our centralized cadre of well-trained research nurses and coordinators.