[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.

Responsibilities

• Provide real-time clinical research case coverage support, document case observations and provide summary reports as required
• Ensure study procedures are conducted in accordance with the approved protocol, regulatory requirements, and Bright Uro guidelines
• Contribute to clinical research development such as study protocols, monitoring plans, and other related clinical and regulatory documents
• Assist in the management of investigational sites from identification and selection to study closure including engaging with the site to ensure preparedness for clinical research
• Advise 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 cases
• Serve as an additional point of contact between the site and Bright Uro
• Assist 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 reports
• Assist or conduct site initiation visits (SIV) and interim monitoring visits (IMVs) such as preparing agendas, checklists, reports, and follow-up letters as appropriate
• Assist in the formulation of instructional materials and training of clinicians, researchers, and other personnel
• Provide 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 data
• Ensure 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 Uro
• Monitor and track participant enrollment and study progress and attend study visits at investigational sites as appropriate
• Monitor 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 site
• Contribute to scientific posters, publications, and other published materials
• Perform other duties or tasks in clinical, research and development, regulatory, sales, marketing, and client services, or as directed by company leadership

Skills

• Must have a minimum of a Bachelor's Degree in a relevant science
• Minimum of 2 years of relevant research experience. Experience may include work in a clinical laboratory, clinic, or pharmacy
• Human Subjects Research and GCP in Medical Devices Certifications must be completed within 30 days of hire
• Willingness and ability to travel a minimum of 80% of the time
• Must reside near a major U.S. airport in the Midwest
• Excellent verbal and written communication skills, including the ability to effectively communicate with internal and external stakeholders
• High level of personal and professional integrity, a strong work ethic, and the ability to work independently while managing and prioritizing multiple tasks simultaneously
• Strong organizational skills with keen attention to detail and thorough documentation practices
• Computer proficiency (Microsoft Office – Outlook, Word, Excel, and PowerPoint)
• Prior startup or early-stage company experience

Company Overview