Clinical Trial Oversight Summit

Faculty List

Adam Chasse, COO, RxTrials

Anna DeMarinis, Principal, The DeMarinis Group, LLC; former Consumer Safety Officer, Health Sciences Administrator, and Policy Analyst, FDA

Bonnie J. Trochanowski, CCRP; Global Medical Quality, Eli Lilly and Company; Kathy Ballensky MT (ASCP), CCRA, Global Medical Quality, Eli Lilly and Company

Bradley Wong, Consultant to Allergan

Candace Friend Shelton, Director, Clinical Monitoring Services, Celerion

Chris Dunk, Ph.D., Head, Clinical Operations, Clinical Research, GFA

Christine E. Buben, MS, MBA, Director, Clinical Operations, Tarsa Therapeutics, Inc.

Dayna Geralts, Manager, Clinical Affairs, Molecular Diagnostics, Hologic, Inc.

Deborah Thibodeaux, Lead Consultant, Management, DKT Lab Consulting, LLC

Derek Gamber, Regional Sales Manager, MedNet Solutions

Doreen McGirl, ASQ-CQA, Associate Director, Compliance, Merck

Elizabeth Ronk Nelson, MPH, President and Senior Consultant, Regulatory Risk Management

Erika Stevens, Senior Manager, Advisory Services Health Care, Ernst and Young LLP

Ethel Kagan, President, Consulting, Innovations Clinical Research LLC

Hope Senechal, BSc, CCRA, Internal Clinical Research Auditor, Ottawa Hospital Research Institute

Jerry B. Perkins, M.D., Former Medical Officer, FDA

Jessica Holthuizen, Senior Director, Clinical Operations Head Metabolism, Global Clinical Operations, Janssen

Joe Popowicz, Director, Clinical Operations, Stryker Orthobiologics

Johanna L. Stamates, RN, MA, CCRC, CHRC, Executive Director, Regulatory Support and Quality Assurance, University of Miami

John M. Isidor, J.D., CEO, Human Subject Protection Consulting, LLC

John R. Wilson, Jr., Ph.D., MPH, Senior Vice President, Beaufort CRO

Jonathan Andrus, MS, CQA, CCDM, Senior Vice President, Operations, BioClinica, Inc.

Kara Lemons Harrison, RAC; RQAP-GCP, Director, Quality Assurance, INC Research, former Field Investigator, FDA

Karen L. Gilbert, BS, CCRA, Clinical Trainer & Curriculum Manager, Barnett International

Kathy Ballensky MT (ASCP), CCRA, Global Medical Quality, Eli Lilly and Company

Ken Schiff, BA, MBA, Quality Risk Management Associates, LLC

Ken Shitamoto, MS, PMP, CPRE, CTFL, Corporate Quality Assurance, Affymax, Inc.

Kevin Saylor, Senior Director, Computer & Lab Systems QA, Millennium Pharmaceuticals, Inc – The Takeda Oncology Co.

Kimberly Washburn, Director, Quality Assurance, Global QA, Quintiles

Kristen L. Bauer, CCRP, Senior Regional Clinical Research Associate, BIOTRONIK, Inc.

Lee Truax-Bellows, President, Clinical, NCRA

Lynn King, Assistant Vice President, Operations, Rho

Marie Jackson, Ph.D., MBA, Director, Clinical Research Administration &, Services, City of Hope

Markus Hartmann, Ph.D., MDRA, Principal Consultant, European Consulting & Contracting in Oncology

Mary Jane Welch, DNP, Director, Human Subjects’ Protection Program, Research Affairs, Rush University Medical Center

Mary-Lynn Fulton, Vice President, Global Research Operations, PAREXEL

Nancy S. Bakke, Manager, Clinical Monitoring, US/Canada, Sorin CRM USA, Inc.

Penelope Manasco, M.D., CEO, Executive, MANA Consulting LLC

Peter Schiemann, Ph.D., Managing Partner, Widler & Schiemann Ltd.

Pierre Corin, Senior Director, Development Operations, Clinical, Cerexa

Randall Basinger, Senior Director, Systems Compliance Office, Global Quality Assurance, Quintiles

Randy Ramin-Wright, MS, Program Manager and QRM Consultant, International Institute for the Safety of Medicines (ii4sm) Ltd.

Rebecca Cope, PMP, Product Manager, BioClinica, Inc.

Roland Rich, Quality & Compliance Excellence, Operations Expert, DevQA, Novartis

Sally Teeters, CCRP, Senior Director, Legal and Business Management, CardioVascular BioTherapeutics, Inc.

Sandra Lawson, Research Coordinator, Pathology, University of Florida Health System

Sara Mochel, Clinical Research Assistant 3/Sr CRA, Clinical Operations, Medivation

Sarah Ramey, CRA, Clinical Operations, Duke Clinical Research Organization

Shankar Srinivasan, Ph.D., CCRC (ACRP); Senior Regulatory Specialist, Office of Research Regulatory Support, Mayo Clinic

Shannon Hohengasser, Associate Director, Research and Development Compliance, Shire

Shari Zeldin, BA, CCRC, Manager, Clinical Research Compliance Office University of Wisconsin Carbone Cancer

Shirley Roach, Regulatory PM, Quality, Allied Technologies and Consulting

Sina Djali, Director, Quality Monitoring and Compliance/Quality Systems, Janssen

Stephannie Perrin, Associate Director, Quality Risk Management, Global Quality and Compliance, PPD

Tabitha K. Westbrook, RQAP-GCP, Manager, Quality Assurance, INC Research, former Head of Quality Assurance, Central IRB

Treena Jackson, MS, CQA, RAC, CSSGB, Quality Resource Consulting, Inc.

Vickie Haines, RN, CRA, Senior Clinical Research Monitor, Sorin CRM USA, Inc.