The UMass Center for Clinical & Translational Science and The Graduate School of Nursing are pleased to announce a new CEU-based educational initiative

Certificate in Clinical Research Management

Overview
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
Relevant to the knowledge, skills and attitudes required to function at a senior level of clinical research management, the certificate program will use a blended approach of web-based 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.  A textbook in Clinical Research Practice will be included in the cost of the program, and distributed at the first class.  On-site classes will be located in the Graduate School of Nursing, Room S1-853.

From March through June, 2011, participants will meet on the 1st and 3rd Friday mornings from 9am to noon.  This activity has been submitted to the Massachusetts Association of Registered Nurses, Inc. for approval to award contact hours.  The Massachusetts Association of Registered Nurses, Inc. is accredited as an approver of continuing nursing education by the American Nurses Credentialing Centers COA.

Course Directors:
Sheila Noone, PhD, Asst. Vice Provost for Clinical Research, UMass Worcester
(508)856-5015
Carol Bova, PhD, Assoc. Professor, Graduate School of Nursing, UMass Worcester
(508)856-1848

Four 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
  • Influence of genetics on clinical research ethics and participation
  • 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.  In the first year of the program, enrollment will be restricted to UMass Worcester and UMass Memorial personnel, and class size will be limited.
Cost: a fee pf $350 will be charged for participation in the series; 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 CGP training attended as well as career goals
2)     Curriculum Vitae or Biosketch
3)     Successful completion of Collaborative Institutional Training Initiative (CITI)-Biomedical Research & Responsible
        Conduct of Research modules
4)     Letter of recommendation from immediate research supervisor, including statement of support to attend 
        class two Friday mornings per month.
APPLICATIONS WILL NOT BE REVIEWED UNLESS PACKET IS COMPLETE

Deadline for Application:  January 21, 2011; Notification of Acceptance: February 4, 2011
Please send complete packets to:
Joan Lynch-Coordinator
Office of the Vice Provost for Research, Room S1-859
Direct any questions about Certificate program content to:
Sheila B. Noone - sheila.noone@umassmed.edu; x65015
Carol Bova - carol.bova@umassmed.edu; x61848

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 Benefits

  • Pilot grant programs eligibility
  • Research core services
    at competitive rates
  • Electronic resources access at Amherst libraries
  • Medical School Library access
  • Consultation services
  • Notification of special events and opportunities

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