Joan K. Mauer has served in CTEP, DCTD since 1982 working in the clinical trial’s quality assurance and compliance area. She was Section Head of the Quality and Assurance Section as part of the Regulatory Affairs Branch for many years. She has been Chief of the Clinical Trials Monitoring Branch (CTMB) since 1999. She established through implementation and designs the DCTD’s audit program. This program encompasses a variety of clinical trials mechanisms; CTMB provides guidance and oversight of the quality assurance and monitoring programs of the Cooperative Groups, cancer centers and Phase 1 clinical trials. She has demonstrated outstanding and innovative methodological designs, their utilization and application to the audit program. The quality assurance program is constantly evolving with emphasis on IND chemotherapy clinical trials, biological agent clinical trials, treatment referral clinical trials, and selected large prevention trials. Ms. Mauer is viewed as a prime resource to the intramural and extramural community for compliance and regulatory problem solving. She also is viewed as an expert for the application and use of HHS regulatory procedures for human subject’s protections and Good Clinical Practices (GCP) for NIH sponsored clinical trials.
Prior to joining the Cancer Therapy Evaluation Program Ms. Mauer was employed in the pharmaceutical industry by Hoffmann-La Roche for thirteen years, where she worked in the Department of Medical Oncology and Immunology. She monitored and worked on the fist clinical trials testing the interferon’s and other biologic response modifiers.
Ms. Mauer received a Bachelor of Science degree in Medical Technology from Moravian College, Bethlehem, PA; she is licensed by the American Society of Clinical Pathologists. She is the recipient of numerous NIH merit awards, NCI Special Achievement Awards and a number of Performance awards.