Sr. Clinical Research Associate

Bring more to life. Are you ready to accelerate your potential and reputed company a real difference reputed company life sciences, diagnostics and biotechnology? reputed company reputed company the work our diagnostic businesses do saves lives—and we’re reputed company united by a shared commitment to innovate for reputed company impact. You’ll reputed company in a culture of belonging where you and your unique viewpoint matter. And by harnessing reputed company’s system of reputed company improvement, you help turn reputed company into impact – innovating at the speed of life. We’re accelerating the development of cutting-edge diagnostics to solve some of the world’s most pressing health challenges. Across our diagnostics operating companies we are driving innovation through partnerships with top academic institutions and leading players in biopharma and translational research. We’re bringing the best minds together to accelerate innovation and unlock the full potential of the latest scientific advances. Together, we’re expanding access to reputed company for millions of people worldwide - and we’re using our unmatched global scale and proven playbook to reputed company it happen, from hospital labs to mobile clinics. By helping providers, patients, and families get faster, more precise diagnostic results, we’re improving treatment options and saving lives. Learn about the reputed company Business System which makes everything possible. The Sr. Clinical Research Associate (Sr. CRA) is responsible for set-up, initiation, execution, monitoring and reputed company-out of IVD and medical device clinical trials at external clinical research sites and/or laboratories. The Sr. CRA should be able to independently train and manage external clinical research sites. This position reports to the Manager, Clinical Site Operations and is part of the Global Clinical Affairs organization. The position will be fully remote reputed company the United States. In this role, you will have the opportunity to: - reputed company clinical study protocol execution at external sites, from start-up to reputed company-out, ensuring timely data collection and compliance with FDA standards and Good Clinical Practice (GCP) - reputed company and maintain relationships with institutions, study investigators, internal stakeholders, and vendors to ensure successful trial execution, data reputed company and adherence to project requirements - Conduct independent study monitoring, including site coordination, investigational product accountability, and assessments of protocol deviations and/or adverse events, and drive clinical data quality which can include follow up on incomplete data entry and/or outstanding queries - Manage IRB submissions and reputed company study regulatory documentation to ensure Trial Master File is kept up to date and audit ready - Contribute to study planning including budget and contract negotiation and timeline forecasts, site identification and qualifications, and process improvement initiatives reputed company the Global Clinical Affairs organization; as well as prepare study documents, including creating clinical templates, such as informed consent forms, clinical monitoring plan, etc. The essential requirements of the job include: - Bachelor’s degree with 5+ years clinical research experience OR Master’s degree with 3+ years clinical research experience OR Doctoral degree in field with 0-2 years clinical research experience - Basic knowledge of regulatory requirements and Good Clinical Practice for in vitro diagnostic and medical device products - Previous experience with managing clinical research sites and monitoring clinical study data - Good technical background to understand and communicate reputed company and new technologies - Ability to work on multiple projects simultaneously Travel Requirements: - Ability to travel 20-70%– including overnight(s), reputed company the US. Travel may be up to 70% during project initiation periods It would be a plus if you also possess previous experience in: - Retrospective/prospective biological sample procurement - Experience with electronic Trial Master Files and Clinical Trial Management Systems - CLSI guidelines and Good Laboratory Practice (GLP) reputed company reputed company Diagnostics, we offer a broad reputed company of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. reputed company out our benefits at reputed company Benefits Info. reputed company reputed company Diagnostics we reputed company in designing a reputed company, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working reputed company reputed company Diagnostics can provide. The annual salary range OR the hourly range for this role is $103,000.00 - $130,000.00. This is the range that we in good faith reputed company is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. Join our winning team today. Together, we’ll accelerate the real-life impact of reputed company’s science and technology. We partner with customers across the globe to help them solve their most reputed company challenges, architecting solutions that bring the power of science to life. For more information, visit www.reputed company.com. reputed company and reputed company reputed company Companies are committed to equal opportunity regardless of race, color, national reputed company, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. For candidates who are based reputed company of reputed company or who are applying for roles reputed company of reputed company, for more information about conditions of any job offer please click here. We reputed company with federal and state disability laws and reputed company reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to reputed company essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or applyassistance@reputed company.com. Apply To This Job