"Re-inventing the Entry-Level Clinical Research Coordinator" Presented by Lauren Ballina Chang, Clinical Research Fastrack/National Program Director
The PMI Atlanta announces a new forum for 2018 - Clinical Research Forum. Join us in the 1st Quarter as we launch this exciting new forum in Marietta!
Presentation
The CRAs complain to us quietly, the site managers try to control their frustration and the surveys confirm this issue we all know to be true. The varying level of knowledge, competency, and professionalism of clinical research coordinators at the site level is problematic in clinical research. The role of clinical research coordinator (CRC) is a technical position requiring working knowledge of ICH GCP and the Code of Federal Regulations. CRCs are required to collect and document data appropriately and accurately. Their work can have direct impact on the efficiency and quality of a trial. Of 60 current clinical research professionals surveyed, 4 (7%) reported purposefully seeking a position in clinical research. The remaining 56 reported that they “fell into clinical research” and stayed because the field is so rewarding. All reported on the job training in their entry-level position as inconsistent and incomplete. Many felt overwhelmed in their first position and that experience and mistakes have been their best teachers. Why is our industry not doing a better job in training new coordinators?
The standardization of entry-level training for clinical research staff is absolutely essential, but still a long way off. Clinical Research Fastrack is disrupting this alarming status quo, one CRC at a time. By delivering a robust curriculum focused on ICH GCP, Code of Federal Regulations, protocol, good documentation practices, adverse events, protocol deviations, clinical trial operations, participant recruitment and retention, responsibilities of study team members (including the PI), informed consent, and research skills all coupled with a hands-on internship at a clinical trial site, CRF is re-inventing the entry-level CRC. This robust entry-level training is having profound effects not only at the site level but is leading to more efficient, ethical, and higher quality work at both the CRO and Sponsor level.
