Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as a Level 4 Clinical Research Associate and grow with Siemens Healthineers. Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways. Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers. This is a role well suited to an ambitious professional, looking for the next step in their career. As a Level 4 Clinical Research Associate, you will be responsible for: · Represents Clinical Affairs on multifunctional Product Development Teams assigned development of low or moderately complex products. Able to assess data and status of products throughout the development cycle and relate to risk of clinical trial success. · Responsible for updating function based on progress of Product Development Core teams and escalating issues that could impact product development timelines or budgets. · Design and preparation of clinical and analytical in vitro diagnostic device performance study plans, protocols, and reports, statistical data analysis plans, and associated study data collection forms. · Supervise junior CRAs assigned to support clinical studies for Product Development Teams · Independently completes all activities related to the set-up, initiation, execution and close-out of in vitro diagnostic device clinical trials including sample collection, timely review and analysis of data generated. · Independently schedules and completes on-site monitoring visits to ensure protocol compliance, accuracy and completeness of clinical data. · Communicates with study investigators via phone, fax, email and/or letters regarding activities in all phases of the study. Develops and maintains ongoing relationships with investigators/institutions/vendors with access to specimens needed in clinical trials. · Completes the coordination with biostatisticians and data managers to manage incoming clinical site data, design/maintain databases, and ensure integrity of the database. · Responsible for monitoring and preliminary analysis of test data. Capable of assessing precision, accuracy, and identifying trends in data. · Provides up-to-date clinical study progress reports. · Negotiates site specific study budgets, initiates and oversees contract origination, compliance approval, and execution. · Completes the tracking of budgets for studies. · Remains current with regulatory requirements for in vitro diagnostic products. · Represents Clinical Affairs on multifunctional team tasked with preparing responses to regulatory agencies. · Represents Clinical Affairs on multifunctional team tasked with the preparation of scientific abstracts, posters, and publications reporting results of the clinical studies. This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers · Knowledge of in vitro diagnostic product design and development and experience as a member of product development core teams preferred. · Awareness of US (21 CFR 820) and EU (ISO 13485) quality system requirements; Understands: Design Control, Good Clinical Practice, In Vitro Diagnostic Regulation, Essential Requirements, labeling requirements, and regulatory requirements of pertinent regions. · The ability to work in a matrix organization with cross-functional teams is required. · Capable of drafting scientific abstracts · Excellent communication skills in person and virtually with presentations, and both oral and written required. Required skills to have for the success of this role · BS/AS in a related scientific field required. · High energy; driven; collaborative; highest integrity. · Travel requirements up to 30% in non-pandemic times Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date, except where prohibited by state law. Accommodations may be requested for certain medical or religious reasons. If you choose to submit an accommodation request it should be submitted within 3 business days of receiving a verbal offer. Details on how to submit approval will be provided by your recruiter. An accommodation approval must be confirmed prior to your start date. A start date cannot be confirmed until the accommodation has been reviewed. An accommodation is based on your role. If you are a currently a Siemens Healthineers employee with an existing approved accommodation, it will need to be re-evaluated prior to starting a new role. At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally. If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about As an equal-opportunity employer we are happy to consider applications from individuals with disabilities. Why you’ll love working for Siemens Healthineers Be part of exciting and innovative projects that help solve some of the world’s most significant health problems. Engaging, challenging, and fast evolving, cutting edge technological environment. Opportunities to advance your career. Competitive total rewards package. Contribute to our social responsibility initiatives focused on access to education and technology, and sustainability, making a positive impact on communities. Participate in our celebrations and social events. Opportunities to contribute your innovative ideas and get paid for them! Employee perks and discounts. We are globally recognized as an Employer of Choice, but don’t just take our word for it. Here are some of our most recent awards and recognition: Great Place to Work Certified 2021 Best Places to Work for LGBTQ Equality Best for Vets Employers by Military Times Glassdoor Employer Rating: 4.0 Organization: Siemens Healthineers Company: Siemens Healthcare Diagnostics Inc. Experience Level: Experienced Professional Job Type: Full-time Equal Employment Opportunity Statement Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. 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