Faculty Bios

Clinical Site Coordinator / Manager and GCP Workshop: 

GCP for Coordinators, Research Associates, Study Nurses, and Site Managers

Course faculty will be both of the following instructors.

Course Leader - Laura Holtz, MS, PMP, CCRP

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.

Course Leader - Tammy Neseth, MA, CCRP, CIP

Tammy Neseth has a background in clinical trial coordination, compliance and regulatory. She is a SOCRA certified clinical research professional (CCRP) and a certified IRB professional (CIP). Ms. Neseth is an experienced leader in research administrative areas and specializes in clinical trial monitoring, site development, GCP training and quality improvement. She began working in clinical trials in 1998 as a study coordinator specializing in colorectal cancer screening at Mayo Clinic. 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. She became the manager of the Mayo Clinic IRB Regulatory Compliance Unit and conducted internal audits, developed policies and procedures to meet applicable regulation, created a pro-active monitoring program and provided compliance, regulatory and GCP education to the research community. Ms. Neseth also oversaw the Office of Research Regulatory Support at Mayo Clinic which was responsible for services provided to investigators to assist them in meeting their regulatory obligations for investigator-initiated, FDA-regulated research projects. Most recently, Ms. Neseth served as the IRB Director for Mayo Clinic. She regularly presents on current topics in clinical research and has developed numerous training and educational programs for research professionals.