Course faculty will be both of the following instructors.
Laura R. Holtz, MS, PMP, CCRP, is a Clinical Research Associate at Yale University Center for Clinical Investigations (YCCI). Previously, she was a senior project manager at the Indiana University Center for Aging Research on federally- funded randomized control trials and demonstration programs to provide care collaboration for patients with dementia and their caregivers in multiple care settings. She also coordinated an annual statewide conference focused on palliative and end-of-life communication and research. She shares her expertise in regulations, informed consent, decision making capacity, patient/caregiver interviewing, ethics, and research project management at numerous local and national conferences. Laura established the Indianapolis chapter of Society of Clinical Research Associates (SOCRA) and organizes education opportunities which provide pathways for staff to become Certified Clinical Research Professionals. She is a co-facilitator for the SOCRA Clinical Site Coordination/ Management and Good Clinical Practice (GCP) workshop and the Certified Clinical Research Professional (CCRP) and GCP Exam Prep course. As the SOCRA Treasurer, she contributes to the organization’s strategic objectives to provide research education, networking opportunities and professional credentialing for the research community. Laura has a Master of Science in Communications from Purdue University.
Tammy Neseth is an experienced leader in research administrative areas including those with regulatory and/or compliance related activities. She began working in clinical trials in 1998 as a study coordinator specializing in colorectal cancer screening at Mayo Clinic. In 2005, Ms. Neseth transitioned from study coordination to regulatory and compliance initiatives as the Audit Program Coordinator for North Central Cancer Treatment Group conducting audits and monitoring visits throughout North America and Ireland. In 2012, she became the manager of the Mayo Clinic IRB Regulatory Compliance Unit. She conducted internal for-cause audits, developed policies and procedures to meet applicable regulation, and provided education to the research community. In 2016, Ms. Neseth assumed management of the Office of Research Regulatory Support at Mayo Clinic and was responsible for overseeing services provided to investigators to assist them in meeting their regulatory obligations for investigator-initiated, FDA-regulated research projects. In 2018, Tammy joined the Mayo Clinic Institutional Review Board where she most recently served as the Director until 2022. She regularly presents on current topics in clinical research and has developed numerous training and educational programs for research professionals.
Tammy has a Master of Arts in Management from Saint Mary’s University of Minnesota. She has been involved with the Society of Clinical Research Associates (SOCRA) since 2003 and was elected to the board of directors in 2011. She has served as Secretary and President of the Society. Tammy co-chairs the SE MN SOCRA Chapter, is a co-facilitator of the annual SOCRA Oncology Conference, and serves on the Certification Committee. She obtained her Certified Clinical Research Professional (CCRP) designation in 2008 and her Certified IRB Professional (CIP) Certification in 2015.