BD (Becton, Dickinson and Company) In-House Clinical Research Associate in Karlsruhe, Germany
Job Description Summary
The In-House Clinical Research Associate (iCRA) supports the day to day operations associated with the execution of clinical trials. The primary objective and purpose of this position is to provide support to clinical project teams, with remote-review of site documentation and study data to ensure the overall quality of clinical trials. The iCRA is the primary contact with remote- and field-based CRAs, and may serve as a secondary point
of contact with clinical investigators and BD study team members, as assigned. The iCRA is responsible regulatory document collection, tracking screening and enrollment, supporting safety reviews and reporting. The iCRA will be assigned to support multiple clinical trial sites and studies. The iCRA is expected to contribute to the development and improvement of company procedures, processes, and templates in support of Global Clinical Development efforts towards continuous quality improvement.
Supports global business units with TMF ownership and accountability
Builds new eTMF study, country and site binders; manages permission groups with direction from eTMF Business and Technical Owners
Serves as a Study eTMF Owner, Provides Level 1 support, completes QC review
Serves as a CTMS Power User, providing Level 1 support and maintenance in areas of troubleshooting, contact, account, document and site management, monitoring visit report process and troubleshooting
Assist in the preparation of study binders, manuals, or other site specific tools
Provide monitoring visit support as a co-monitor as needed, and supports: site qualification, site training, routine monitoring and close out visits, monitoring visit reporting
Account for investigational devices ensuring the devices are available, stored appropriately, and accurately inventoried and documented
Verify appropriate reporting and documentation of adverse events and protocol deviations per internal and protocol requirements
Ensure TMF and site regulatory binder are current and aligned
Primary Work Location
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.