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. Sustainably.

At Siemens Healthineers, we offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally.

Our Global Team:

We are a team of more than 72,000 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.

The Clinical Research Associate (CRA) is responsible for supporting clinical activities to generate clinical evidence that will support product registration and/or product market clearance/approval. This position is part of the Varian Clinical Operations Department. The CRA will be a critical member of the clinical operations team supporting Varian’s clinical investigations with both remote and on-site monitoring. The CRA will be responsible for management of assigned investigator sites and all monitoring activities for assigned studies. This CRA position must be executed in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and any other applicable regulatory requirements.Performs site initiation visits, interim monitoring and close-out visits (performed on-site or remotely) ensuring applicable regulatory compliance, ICH-GCP, and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the study team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.Per the Clinical Monitoring Plan (MP):Assesses site processesConducts Source Document Review of appropriate site source documents and medical recordsVerifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical recordsApplies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelinesUtilizes available hardware and software to support the effective conduct of the clinical study data review and captureVerifies site compliance with electronic data capture requirementsVerifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations issues.Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Assist in audit readiness and preparation. Support clinical activities to stay in compliance with the study Monitoring Plan requirements and compliance to Protocol, applicable regulatory standards, IRB policies and procedures.Identification of protocol deviations and data discrepancies to drive compliance to study protocol(s), applicable regulations, GCP, and SOPs.Partner with data management team to effectively operate within data management plan and data management procedures.Develop and maintain positive relationships both internal and external to project, including clients, team members, and site personnel (PIs, Study coordinators, etc.).Maintain current knowledge of GCP and applicable regulation guidance (i.e., FDA, ISO, MDR) as it relates to clinical research study assigned. Verifies the study device has been dispensed and administered to subjects/patients according to the protocol. Applies knowledge of GCP/local regulations and organizational procedures to ensure the study device is appropriately (re)labelled, set-up, and returned.Documents activities via confirmation letters, follow-up letters, communication documents, and other required project documents as per SOPs and Monitoring Plan. Supports subject/patient recruitment, retention, and awareness strategies.May act as primary liaison with study site personnel, or in collaboration with the Clinical Study Manager.  Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements via source verification.Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates, and may, with supervision, lead, clinical monitoring/project staff meetings. (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the clinical study specific requirements.This is a remote role across the US or Canada with up to 10 to 30% travel requirements.Minimum bachelor’s degree with 1 to 3 years relevant experienceCertified clinical research professional is a plus

#LI-Remote

The annual incentive target is 5% of base pay.  Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay.   Details regarding our benefits can be found here: https://benefitsatshs.com/index.html

Equal Employment Opportunity Statement
Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Reasonable Accommodations
Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.

If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.

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A Successful candidate must be able to work with controlled technology in accordance with US export control law when required. It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.

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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. 

The base pay range for this position is

Min $90,600 - Max $135,900

Base pay offered may vary depending on job-related knowledge, skills, and experience. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay.  

This information is provided per the required laws and regulations. Base pay information is based on market location. Applicants should apply via Siemens Healthineers external or internal careers site

Position must have full access to Siemens Healthineers' client sites to perform the essential functions of this position. Many clients require Simens Healthineers employees and representatives to meet certain Vendor Credentialing requirements before they will be allowed to have access to their sites. Unless prohibited by law, position must meet all Vendor Credentialing requirements necessary to have full client access and must continue to meet those requirements during the course of employment in this position. These requirements vary by client and may include, but are not limited to: Proof of valid identification (photo, driver's license, SSN) Criminal background checks Drug screens Immunizations (COVID-19, Hep B, MMR, Varicella, Influenza, Tetanus) Annual TB testing Healthcare training.

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As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.