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Senior Clinical Research Associate - Oncology - East Coast - Remote

Remote · Italy Full-time

*SUMMARY Responsible for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.* What Clinical Operations does at Worldwide At Worldwide Clinical Trials, we invite you to embark on a rewarding journey within Clinical Operations, where your contributions will leave a profound impact on the lives of patients. As a Clinical Research Associate (CRA) at Worldwide, you will find yourself working alongside brilliant minds across diverse therapeutic areas, including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases. Collaboration with top-tier colleagues from various backgrounds and specialties is not just encouraged; it's ingrained in our culture. Our commitment to advancing clinical research is nurtured within a supportive and team-oriented environment. In a CRA role, you'll receive extensive support through regulatory submissions, TMF management, and in-house CRAs for projects with heavy site management needs. Through regular touchpoints and coaching conversations with your Line Manager, we ensure that your professional development remains a top priority. We offer a clear career path and development that can lead to Clinical Trial Manager roles. We take pride in our accessible Executive Leadership team, who are equally committed to advancing science and surmounting obstacles to make a difference in the lives of patients around the world. We offer an unparalleled experience, where you can drive remarkable scientific breakthroughs and be at the very core of every successful clinical trial. Experience a world of difference with us at Worldwide! What you will do - Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects - Typically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the site's activities during study maintenance, and closing down research activities at the sites once the study has concluded - Conduct study initiation visits (SIVs) - While most of the site management efforts will be performed remotely, you will be required to ensure compliance with obtaining informed consent, reporting potential safety-related events, and adhering to all applicable regulatory requirements What you will bring to the role - Excellent interpersonal, oral, and written communication skills in English - Superior organizational skills with attention to detail - Ability to work with little or no supervision - Proficiency in Microsoft Office, CTMS, and EDC Systems Your experience - 5+ years of experience as a Clinical Research Associate - 4-year university degree OR Nursing Degree - Experience in Oncology is required - Candidates must reside on the East Coast, United States - Willingness to travel regionally required We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at ! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

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