Accelerate your CRA career and get instant answers to your toughest clinical research procedural questions. 
 The faster you attain advanced levels of competence especially on new electronic portals, questionnaires and processes the more self-assured you'll be and the more rapid your career development. 
 Likewise, in order to instill confidence in your clinical research teams, it pays when you show unhesitating knowledge of current FDA regulations, as well as Good Clinical Practice and pharmaceutical research guidelines from prevailing authorities. 
 This new edition of The CRA's Guide to Monitoring Clinical Research all 750 pages helps you do both: You ll have the profession s definitive description of CRA job responsibilities, including new digital processes, as well as a complete guide to procedural regulations and guidelines. 
 Even as the CRA's role becomes more complex, this new edition of The CRA's Guide to Monitoring Clinical Research keeps you steps ahead. 
 The Guide puts you on the forefront so you can help lead the way using new digital developments in clinical research to improve safety reporting, informed consent, and patient-reported outcomes. 
 The CRA's Guide to Monitoring Clinical Research also ensures that you can rapidly embrace emerging techniques, such as remote monitoring, wearable devices and tablets &amp; and smoothly adapt, integrate and employ them to the fullest advantage of your research. 
 Only The CRA's Guide also helps you command the soft skills critical to a successful CRA career including: 
 Communication insights: Every veteran CRA confirms it: Your success absolutely depends on communicating effectively with all members of your clinical research teams. That's why The CRA s Guide to Monitoring Clinical Research offers dozens of communications take-aways inside techniques to attaining smooth cooperative relationships with your sites, as well as maintaining a high standard of due diligence. 
 High index of suspicion: The CRA's Guide is the only resource that helps you develop a sharp eye for potential problems and errors that can threaten the integrity of clinical trials. This heightened awareness helps the CRA know when to communicate and escalate in a timely fashion to prevent protocol or GCP violations. 
 The most complete guide to successful practices of high-performing CRAs helps you respond to thousands of challenges in your busy career.

The CRA's Guide to Monitoring Clinical Research, Fifth Edition

Elizabeth Weeks-Rowe

CenterWatch/WCG

Product Description As the clinical research enterprise continues to evolve at a rapid pace, the physician investigator is charged with meeting the demands of conducting faster clinical trials, adhering to stricter requirements from sponsors and regulatory bodies and managing increased competition in the market all while maintaining the highest quality and patient safety standards. The PI s Guide to Conducting Clinical Research, first published in 1997 and previously titled Becoming a Successful Clinical Research Investigator, is the only industry resource designed to assist both novice and experienced PIs in meeting these higher, more challenging expectations to conduct better, safer and more efficient clinical trials. Investigators will learn to: -Understand investigator responsibilities from practical and ethical study conduct to site and financial management -Secure new clinical studies, assess feasibility and create study budgets Comply with changing federal regulatory guidelines -Practice ICH-GCP guidelines Implement and adhere to strict standard operating procedures -Recruit and retain study volunteers Understand informed consent and human subject protection -Prepare for sponsor or IRB audits -Prepare for certification exams and more Recommended for: -Physician investigators, sub-investigators and clinical research scientists interested in or already conducting clinical trials for pharmaceutical or biotech companies -Instructors conducting clinical research training and educational programs -Professors or researchers developing college curriculums -Sponsors, CROs, SMOs and academic institutions interested in providing a reference manual for their investigators About the Author Elizabeth Weeks-Rowe, LVN, CCRA, has spent over 18 years in a variety of clinical research roles including study coordinator, CRA, CRA trainer, CRA manager and clinical research writer. She has developed training content and presented clinical research topics for leading industry training and education organizations. She has created marketing content, website content and clinical operations newsletters for European and U.S.-based clinical research organizations. She is a contributing writer for several leading industry publications, including a recurring clinical research column for a leading clinical research news publication. She has authored a white paper on best industry practices for co-monitoring assessments, and unblinded pharmacy monitoring/ monitoring practice. She is the author of a clinical research novella entitled, Clinical Research Trials and Triumphs; a heart warming novel following a nurse s journey into clinical research. She is an instructor for a well known clinical research training company and speaks at global industry clinical research meetings. For the last 7 years, she has worked in a critical site selection and training role for a leading CRO.

The PI's Guide to Conducting Clinical Research, Second Edition

Medical Books

Nursing

CenterWatch

The CRA's Guide to Monitoring Clinical Research, fourth edition, continues to be a vital resource for both novice and experienced CRAs seeking to learn more about the field of monitoring or to better understand their roles and responsibilities as the industry becomes more global and technologically focused. This edition includes helpful tips and strategies, checklists, personal experiences, traveling tips, key takeaways and exercises. With new and updated chapters on the evolving CRA roles and responsibilities, monitoring for device and biologic trials, risk-based monitoring, globalization of studies, EMR, web-driven data collection, the sub-PI role, and more, The CRA's Guide is a must-have training and educational tool that you'll refer to time and time again.

The CRA's Guide to Monitoring Clinical Research, Fourth Edition

Karen E. Woodin Ph.D.

John C. Schneider

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Books by Elizabeth Weeks-Rowe