Ensure overall study progress (screening, enrollment, data entry, etc.) through regular communication with cross-functional teams, clinical trial sites and contract research organizations
Support the management of trial vendors such as contract research organizations and core labs
Develop project plans and ensure adherence to budget, timelines, and SOPs
Assist in the development and provision of the clinical components of regulatory submissions to competent authorities and notified bodies
Participate in the creation of clinical study plans, committee charters and other trial documentation
Assist with the development of the electronic case report forms
Participate in study start-up activities (e.g., tracking site readiness, communication with clinical trial sites about planning and logistics of site qualification, initiation, and activation)
Coordinate with sites for ethics committee (EC) and Institutional Review Board (IRB) submissions, including drafting and negotiating the informed consent
Facilitate the negotiation of clinical trial agreements, study budgets and other relevant documents
Participate in site initiation visits; train site personnel on sponsor and regulatory requirements for study conduct; participate in and/or conduct site meetings
Support clinical study committee activities and maintain committee documentation
Maintain accurate clinical documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, and US and OUS regulations
Ensure adherence to clinical trial procedures by keeping oversight, identifying possible problems / risks, creating mitigation plans, taking actions or corrective actions using timely communication
Support the management of site monitoring, data management and safety reporting activities by the contract research organization 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 study
Contribute with development and delivery of trainings; GCPs, protocols, database, compliance, device accountability, and adverse event reporting
Assist in the development of in-house operations SOPs, guidelines and systems
Oversee site closeout visits including the collection, retention, and archival of closeout documentation
Bachelor’s degree in a relevant technical field (RN, BSN, PA, NP, etc.) or equivalent/related experience.
5+ years clinical research experience. Certified Clinical Research Professional (CCRP certification) preferred.
Experience conducting trials at the sponsor level for products in the cardiac and neuro spaces strongly preferred.
Must have a demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations.
Well organized and detail oriented, strong written and verbal communication skills.
Ability to travel 10-20% internationally.
Presentation skills and the ability to articulate procedure details.
Ability to prepare and present effectively written and verbal communications.
Ability to work in a self-driven capacity, with a sense of urgency and limited need for oversight.
A comprehensive ability to analyze and evaluate technologically complex devices.
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 vaccination for COVID-19 for our U.S. employees, contractors, and business partners, where local conditions allow, who:
1) Are customer-facing (e.g., those required to visit a customer/business partner site or interact in-person with customers at any conference or meeting) OR
2) Come on-site, whether regularly or occasionally, at any Siemens Healthineers location.
(Note: Accommodations may be requested for certain medical or religious reasons)
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.
Organization: Siemens Healthineers
Company: Corindus, Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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