The UMass Center for Clinical & Translational Science, in collaboration with the UMass Graduate School of Nursing and the Dartmouth Center for Clinical & Translational Science

is pleased to announce for 2013:



The effective and efficient management of clinical research is a critical need for the evolving arena of clinical and translational science. For the advancements in science and medicine to translate to improvements in the health of patients and the community, the research management team must have deep knowledge of research ethics, regulations, and standards for Good Clinical Practice (GCP) across the life cycle of clinical studies. The goal of this Certificate in Clinical Research Management is to enhance the knowledge base of the clinical research workforce, especially in the area of complex clinical trials, strengthening the supports for the clinical investigator and ensuring the protection of research participants. In concert with the objectives of the UMass Center for Clinical & Translational Science, this more formalized workforce development initiative demonstrates our institutional commitment to competency-based research practice.

Teaching Methods:

This certificate program will use a blended approach of contemporary readings, assignments and on-site seminars. Case studies will be relied upon to give students a chance, individually and in teams, to problem-solve critical issues for safe and ethical research practice.

The 2013 series will meet in full day sessions on four (4) consecutive Fridays during March: 8th, 15th, 22nd and 29th. Sessions will be located at the South St campus of UMass in Shrewsbury, convenient for highway access and parking. This activity has been approved by the Massachusetts Association of Registered Nurses, Inc. for award of contact hours. The Massachusetts Association of Registered Nurses, Inc. is accredited as an approver of continuing nursing education by the American Nurses Credentialing Center’s COA.

Course Directors:

Carol Bova, Ph.D.

Associate Professor, Nursing and Medicine

Graduate School of Nursing; Department of Medicine

University of Massachusetts Worcester

Sheila B. Noone, Ph.D.

Executive Director, Dartmouth Center for Clinical & Translational Science

Asst. Vice President, Clinical & Translational Research – Dartmouth College

Assistant Professor, UMass Graduate School of Nursing


Competency-based modules will include the following topics:

Clinical Research Ethics – Participant-centered approach

Research feasibility review and assessment

FDA Regulatory understanding – drugs, devices and biologics (IND, IDE)

OHRP Regulatory understanding – Common Rule

Recruitment and retention planning (including vulnerable populations)

Community-based research – engagement and obligations

Managing Investigator-initiated Studies

Innovations in IRBs and Human Research Protection Program (HRPP)

Monitoring of clinical trials, reporting and resolution

Target Audience:

Research nurses/managers, coordinators, and regulatory personnel with a minimum of three years full-time experience in a professional clinical research role will be eligible to apply.

Cost: a fee of $350 will be charged for participation in the series, payable by 1st class; this will include award of Contact hours and cost of a textbook in Clinical Research Practice

Certificate Program Application Requirements:

1) Personal statement of interest; any previous basic GCP training attended as well as career goals


2) Curriculum Vitae or Biosketch


3) Successful completion of Collaborative Institutional Training Initiative (CITI) – Biomedical Research and Responsible Conduct of Research modules


4) Letter of recommendation from immediate research supervisor, including statement of support to attend 4 full-day classes on consecutive Fridays



Deadline for Application: February 18, 2013

Please send complete packets to:

Carol Bova, PhD

Graduate School of Nursing

UMass Worcester - Room S1-853

55 Lake Avenue North

Worcester, MA 01655

By email:

Direct any questions about Certificate program content to:

Carol Bova –; office: 508-856-1848

Sheila Noone –; office: 603-650-7037


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