Clinical Research Associate I (CRA I)

About Bright Uro:

Bright Uro is a fast-growing medical device startup headquartered in Irvine, CA, on a mission to improve the lives of millions affected by lower urinary tract symptoms (LUTS). We develop cutting-edge diagnostic technology that integrates advanced hardware, intuitive software, and powerful data analytics — enabling clinicians to gain actionable insights while delivering a better patient experience. We're passionate about advancing urologic care through innovation, and we're building a collaborative, dynamic team to bring transformative solutions to life.

About the Role:

The Clinical Research Associate I (CRA I) is an exciting entry point into the world of clinical research at Bright Uro, offering hands-on exposure across the full lifecycle of a clinical study — from site identification and initiation through data collection and study close-out.

As a CRA I, you'll work at the intersection of science, patient care, and regulatory rigor. You'll collaborate closely with investigational sites, clinicians, and internal teams to ensure studies are conducted with integrity, precision, and compliance. Whether you're providing real-time case coverage support, training site personnel on investigational devices, or contributing to study protocols and publications, your work will directly support the development of technologies that improve patient outcomes.

This is a largely travel-based position requiring routine on-site presence at clinical study locations throughout the Midwest, but additionally the East or West Coast as needed. Candidates must be based on the Midwest. This role is ideal for someone who is detail-oriented, thrives in a dynamic environment, and is eager to grow their clinical research career at a company where their contributions truly matter.

Duties and Responsibilities:

The Clinical Research Associate I (CRA I) is responsible for assigned aspects of clinical research, in accordance with, applicable Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP). The CRA I will perform the following activities as directed:

• 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.

Education and/or Work Experience Requirements:

• 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.

Required Qualifications:

• 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).

Nice to Have:

• Prior startup or early-stage company experience.