New CCTS Clinical Trials Office (CTO) Research Seminar

New CCTS Clinical Trials Office (CTO) Research Seminar

 

Starting in June, critical research implementation and management topics will be presented on the first and third Thursday at noon in PCAMS (1924 7th Avenue South). These topics will be of interest and relevance specifically to clinical research personnel including investigators, regulatory personnel, study coordinators and financial administrators.  The goal of this new program is to fill in the gaps in information related to the implementation of clinical trials that have been identified by investigators and their research teams. The seminar series is directed by Penny Jester, co-director UAB Clinical Trials Office.     

  • July 17:  Newly Released Harmonized Core Competency Framework for the Clinical Research Professional and Proposed Site Certification

 
Presentor:  Carolynn Thomas Jones, DNP, MSPH, RN
 
This 1 hour program will review the just released Harmonized Core Competencies for Clinical Research Professionals.  Dr. Jones has been part of an international joint task force consisting of representatives from pharmaceutical companies, contract research organizations, academic institutions, clinical research sites and professional societies.  The group reviewed and analyzed competency publications and statements that identified competency domains (broad categories of knowledge, skills and attitudes) which are necessary to function within the field of clinical research.  Materials from NIH CRN2010; Oncology Nursing Society (ONS); NCATS; International Federation of Pharmaceutical Physicians (IFPP) Academy of Physicians in Clinical Research (APCR); Consortium of Academic Programs in Clinical Research (CoAPCR) and Association of Clinical Research Professionals (ACRP) were included.  The resulting eight competency domains have been published as a white paper (see attached copyright released URL) that was disseminated by ACRP (Clinical Researcher), Centerwatch (White Paper EPublication), Applied Clinical Trials (Journal) and MAGI (Journal of Clinical Research Best Practices).  This will also be circulated through research journals in Latin America, translated in Spanish.  Ultimately the Joint Task Force plans additional research on the competencies among professionals working in the field and will seek to obtain permission to house these competencies with the International Conference on Harmonization.  
 
Attendees will gain information on expectations and requirements for what clinical research professionals should master and how the competencies could be used to map and develop job descriptions and organizational structures.  See Applied Clinical Trials  for a copy of the above-mentioned white paper.
 
Attendees:  Research nurse coordinators and managers, research nurses, HR personnel, investigators and administrators.
 
  • August 7, 2014: FDA Audit:  Will you be ready?

PresentorPenny Jester, BSN, MPH and Susan Branscum, CCRP

This program will review the how, what, where and why of an FDA audit.  Attendees will leave with guidance and tools to assure they are prepared for an audit.

AttendeesResearch nurse coordinators and managers, research nurses, HR personnel, investigators and administrators.

  • August 21, 2014: Architecture of a Clinical Trial Program

PresentorTiffany Felix, M.S.   Assistant Director, Clinical Trials, USA Mitchell Cancer Institute

This program will provide an overview of the structure and function of a clinical trial program.

Attendees Research nurse coordinators and managers, research nurses, HR personnel and administrators.

 
 

Training is on the 1st and 3rd Thursday of each month in PCAMS (1924 7th Ave S) and continues beyond the titles listed here. For more information, visit the Research Education page of the CCTS website.  Questions?  Contact the CCTS.

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