[Remote] Clinical Research Associate I (CRA I) - Midwest Based

Note: The job is a remote job and is open to candidates in USA. Bright Uro is a fast-growing medical device startup headquartered in Irvine, CA, focused on improving lives affected by lower urinary tract symptoms. The Clinical Research Associate I (CRA I) will manage various aspects of clinical research, ensuring compliance with regulatory requirements while collaborating with investigational sites and internal teams.ResponsibilitiesProvide real-time clinical research case coverage support, document case observations and provide summary reports as requiredEnsure study procedures are conducted in accordance with the approved protocol, regulatory requirements, and Bright Uro guidelinesContribute to clinical research development such as study protocols, monitoring plans, and other related clinical and regulatory documentsAssist in the management of investigational sites from identification and selection to study closure including engaging with the site to ensure preparedness for clinical researchAdvise and train site personnel in the proper study procedures and use of investigational devices, software applications, and/or study-specific tools as appropriate, including enforcing said training and troubleshooting device or procedural issues during casesServe as an additional point of contact between the site and Bright UroAssist in the planning and conduct of meetings (e.g., Investigator, Data and Safety Monitoring Board, Scientific Advisory Board), as well as the preparation of meeting minutes and reportsAssist or conduct site initiation visits (SIV) and interim monitoring visits (IMVs) such as preparing agendas, checklists, reports, and follow-up letters as appropriateAssist in the formulation of instructional materials and training of clinicians, researchers, and other personnelProvide continuous data review of source documents and case report forms (CRFs) (i.e., source data verification [SDV]) to ensure the timely, accurate, and complete collection and submission of study dataEnsure all required study documentation is completed at various stages of the clinical study (e.g., initiation, close-out) and maintain specific records of research activity for Bright Uro (e.g., Trial Master File [TMF])Manage study supplies and ensure remaining study supplies are returned to Bright UroMonitor and track participant enrollment and study progress and attend study visits at investigational sites as appropriateMonitor study progress to ensure compliance with the protocol requirements, FDA regulations, and Good Clinical Practice (GCP) to identify, address, and resolve issues and problems as they might occur at the investigational siteContribute to scientific posters, publications, and other published materialsPerform other duties or tasks in clinical, research and development, regulatory, sales, marketing, and client services, or as directed by company leadershipSkillsMust have a minimum of a Bachelor's Degree in a relevant scienceMinimum of 2 years of relevant research experience. Experience may include work in a clinical laboratory, clinic, or pharmacyHuman Subjects Research and GCP in Medical Devices Certifications must be completed within 30 days of hireWillingness and ability to travel a minimum of 80% of the timeMust reside near a major U.S. airport in the MidwestExcellent verbal and written communication skills, including the ability to effectively communicate with internal and external stakeholdersHigh level of personal and professional integrity, a strong work ethic, and the ability to work independently while managing and prioritizing multiple tasks simultaneouslyStrong organizational skills with keen attention to detail and thorough documentation practicesComputer proficiency (Microsoft Office – Outlook, Word, Excel, and PowerPoint)Prior startup or early-stage company experienceCompany OverviewBright Uro is an early-stage medical technology company. It was founded in 2021, and is headquartered in Aliso Viejo, California, USA, with a workforce of 11-50 employees. Its website is https://brighturo.com/.