GCP for Coordinators, Research Associates, Study Nurses, and Site Managers
Course faculty will be both of the following instructors.
Clinical Research Leader, Project Manager – Indiana University School of Medicine, Department of Medical and Molecular Genetics
Laura Holtz is an experienced leader in clinical research and clinical trials project management. Her research experience includes managing multiple complex research trials, including recruiting, and facilitating studies with vulnerable subject populations, Alzheimer’s disease and related dementias, persons residing in nursing facilities, dyad and triad subject groups. Her expertise is in research site project management, IRB regulation, quality informed consent and decision-making capacity, qualitative interviewing, and data collection. She has coordinated a state-wide conference for palliative care researchers and clinicians for multiple years. She is a Certified Clinical Research Professional through the Society of Clinical Research Associates (SOCRA).
Laura has a Master of Science in Communications from Purdue University. She is the Treasurer on the Board of Directors for SOCRA, co-chairs the Indianapolis SOCRA chapter, contributes to the SOCRA Annual Conference planning committee, and is a co-facilitator for the SOCRA Clinical Site Coordination/ Management and Good Clinical Practice (GCP) workshop.
Director, Institutional Review Board – Mayo Clinic
Tammy Neseth is Director of the Mayo Clinic Institutional Review Board. She 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 IRB. 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.