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

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 & 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.