Description : 23 Mar, 2023
As a Clinical Research Associate you will be partnering with a pharmaceutical company committed to discovering and developing treatments that improve and save people s lives with a focus on Oncology studies. Working in this program you will feel challenged and supported to advance in your professional career while making a truly impact. Responsible for evaluating, initiating, monitoring and closing out clinical study sites. Documents all activities in clear, comprehensive and accurate Monitoring Visit Reports, Contact Reports and follow-up letters within required timelines. En s u res that the conduct of clinical studies at sites is in accordance with the protocol/protocol amendments, Good Clinical Practice regulations, International Harmonization Guidelines, applicable company Standard Operating Procedures (SOPs), and all applicable regulatory requirements. Properly trains/re-trains site personnel on the protocol/protocol amendments, systems utilized in the study, and all operational aspects of the trial. Serves as primary contact for site personnel, acting as liaison between site personnel and sponsor study team members. Develops patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines. You are: Minimum of 2+ years of experience in the pharmaceutical / biotechnology industry monitoring as a Clinical Research Associate from study start-up to database lock. Strong Oncology monitoring experience in phase 1-3 pharmaceutical/ biotechnology clinical trials Possess good understanding and working knowledge of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, and other relevant, local regulatory requirements G ood knowledge of concepts of clinical research and drug development CRA - United Kingdom Remote: Benefits of Working in ICON: Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development. At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future. ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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