The CRC's Guide to Coordinating Clinical Research, 3rd edition, is the most comprehensive, easy-to-read training guide for novice and experienced clinical research coordinators. The newly-released third edition includes industry facts, insights on the role and responsibilities, personal experiences to learn from, checklists to help you be successful and efficient as a CRC, key takeaways, case studies, and much more on this important role in the clinical research industry.
With 65% of new content and 35% updated content, the CRC Guide is the ideal go-to resource for professionals interested in pursuing a clinical research coordinator position as well as an easy-to-reference training guide for experienced CRCs, on-site professional development courses, and professors teaching courses in this field.
Karen E. Woodin earned her M.S. in Applied Statistics at Western Michigan University and her Ph.D. in Epidemiology from the School of Public Health at the University of Massachusetts, Amherst.
Dr. Woodin has over 30 years of experience in the pharmaceutical industry, including more than 20 years at The Upjohn Compa-ny/Pharmacia (now part of Pfizer), where she worked in the areas of biostatistics, clinical trial operations and monitoring and drug safety. She currently works as an independent consultant specializing in clinical trial operations, good clinical practices (GCPs) and standard operating procedures (SOPs). She works with investigative sites, sponsors and IRBs, and also develops and teaches courses in these areas. In addition to authoring this book, she is the co-author of The CRA s Guide to Monitoring Clinical Research, also published by CenterWatch.
Dr. Woodin is a long-time member of the Drug Information Associa-tion (DIA) and has served on the DIA board of directors and as chair of the Steering Committee for the Americas. She has also developed and taught courses for DIA. She is a recipient of the DIA Outstanding Ser-vice award.
SAM has over 30 years of clinical experience, a Bachelor of Science degree in Nursing and a Master of Science degree in Education with a Specialization in Training and Performance Improvement. She has served many roles in clinical research including site study coordinator and manager, sponsor and CRO monitor, quality as-surance auditor, risk manager, trainer and performance management consultant. SAM has held clinical research certifications for over 15 years by the Association for Clinical Research Professionals (ACRP). She is a current member of the ACRP Academy Board of Trustees and the Regulatory Affairs Committee (RAC).
Sandra is a frequent subject-matter expert for GCP regulation and a speaker at industry conferences. She is a strong advocate for research sites and supports the sites that establish quality systems to support the investigator oversight of clinical trials to ensure human subject protection, data integrity and site performance excellence. SAM has authored dozens of competency-based curriculums for study coordinators and site monitors.
