June 10, 2015

TRI, ORC Help UAMS Certified Research Specialist Numbers Grow Nearly 60 Percent

The UAMS Translational Research Institute (TRI), in partnership with the UAMS Office of Research Compliance (ORC), recently helped increase participation in UAMS’ Certified Research Specialist (CRS) Program from 100 to 170 employees, thanks to a supplemental training grant from the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS).

The 59 percent increase over a six-month period came as TRI and ORC introduced progressive, high-level training opportunities to encourage seasoned investigators and research staff to pursue ongoing research education at an advanced level. As part of the effort, all training sessions are being offered via live WebEx and courses have been converted to an online format via LearnOnDemand, including: Writing Standard Operating Procedures, Advanced Research Ethics, Expanded Access to Investigational Drugs, and Data Collection.

“Expanding participation in the program has fostered an environment of confidence and provided increased numbers of research staff with the peer support needed to carry out the human subjects’ studies in their respective departments,” said TRI’s Amy Jo Jenkins, M.S., who led implementation of the new training approaches in partnership with Darri Scalzo, UAMS’ Research Compliance Officer.

The CRS program, managed by the ORC, requires that participants maintain Collaborative Institutional Training Initiative (CITI) Human Subjects Research training, complete 28 hours of relevant coursework, and pass a comprehensive proficiency exam. Graduates of the program earn the “CRS” designation and maintain their certification status by completing 6 contact hours in applicable coursework in subsequent years. TRI continues to require its research support staff complete and maintain CRS certification and other departments within the institution have also adopted CRS certification as a job requirement for certain research-related positions.

Also as part of the training grant, TRI co-sponsored a day-long workshop in basic human subjects research training and offered advanced training opportunities on topics such as data collection, research ethics, expanded access to investigational drugs, genetic and genomic research, 21 CFR Part 11, in-vitro diagnostics, recruitment, and research fraud and misconduct.

In addition, TRI is pursuing the purchase of the Association of Clinical Research Professionals’ (ACRP) eLearning Modules and plans to work with the ORC to incorporate the Good Clinical Practice (GCP) activities as a requirement in the CRS program. The modules will be available to all investigators and research staff at TRI Hub sites (Arkansas Children’s Hospital and its Research Institute, Central Arkansas Veterans Healthcare System and the UAMS Northwest Campus).