Now’s our time to inspire the future of healthcare together.
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
Join our team now at Siemens Healthineers as Clinical Research Field Specialist
Corindus, Inc., a Siemens Healthineers Company is a global technology leader in robotic-assisted vascular interventions. The company's CorPath® system is the first FDA-cleared medical device to bring robotic-assisted precision to percutaneous coronary and peripheral interventions. Corindus is advancing the field of interventional medicine with robotics through improvements to procedural control, precision and workflow.
This position reports to the Clinical Research Manager and is responsible for clinical trial site management, case coverage and clinical trial data tracking. The Clinical Research Field Specialist works closely with study sites to conduct CorPath System clinical studies designed to deliver procedural control, offer robotic precision and provide radiation safety during vascular interventional procedures. As part of a multi-disciplinary group, this position contributes to the design, development and product launch of Corindus’ innovative robotic systems that bring improved care to patients and physicians.
- Case coverage or technical support assistance for clinical research procedures within the Interventional environment.
- Responsible for gaining and maintaining knowledge of clinical sites to best understand and assess investigators' interests and capabilities.
- Conducts clinical trial site initiation visits; advises and trains site personnel on sponsor and regulatory requirements for study conduct; participates and/or conducts site meetings and multicenter investigator meetings and prepares reports.
- Conducts site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines and policies.
- Performs miscellaneous job-related duties as assigned. Ensuring compliance with SOPs and local regulations, and ICH-GCP guidelines.
- Oversee preparation of and revisions to the Clinical Investigation Plan for assigned clinical studies.
- Interface with, and assure training of investigators, site staff, and Corindus clinical staff.
- Assist in site initiation (e.g. oversight of start-up document preparation, distribution, receipt, and review).
- May proctor or provide case support.
- Assist in compilation and review of adverse event information.
- Assist in compilation, review and conclusion of device complaints.
- Oversee activities performed by Contract Research Organizations (e.g. CROs, core labs).
- Ability to travel 75%.
Must Have (minimum requirements):
- At least 5 years of related work experience required. Strong clinical orientation. Experience in neurovascular procedures, peripheral vascular intervention and interventional cardiology; familiarity with clinical trial management also strongly preferred.
Nice to Have (Preferred Qualifications):
- Degree in engineering, life sciences, or related medical/scientific field.
- Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
- Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
- Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications.
- Experience in managing clinical trial data review.
- Ability to incorporate and adhere to good clinical practices and regulatory standards.
- Ability to manage multiple clinical research sites with proven results in study execution.
- Ability to identify and implement solutions in addressing study issues.
- Basic understanding of biostatistics and trial design.
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 Siemens Healthineers 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.
Organization: Siemens Healthineers
Company: Siemens Corporation
Experience Level: Experienced Professional
Job Type: Full-time
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