Clinical Development Internship (Undergraduate)

ABOUT US: Biodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients. Biodesix Diagnostic Tests support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. Biodesix Development Services enable the world’s leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics. Our Mission: Transform patient care and improve outcomes through personalized diagnostics that are timely, accessible, and address immediate clinical needs. Our Vision: A world where patient diseases are conquered with the guidance of personalized diagnostics. For more information, please visit www.biodesix.com LOCATION: On-Site in Louisville, CO PROGRAM DATES: May 17 to August 6, 2027 TIME COMMITMENT: 20 to 40 hours per week THE ROLE As a Clinical Development Intern, you'll support projects focused on clinical site quality, regulatory documentation, and study performance. Working alongside members of the Clinical Development team, you'll gain exposure to clinical research operations, Good Clinical Practice (GCP) standards, and the processes that help ensure the quality and compliance of clinical studies. Throughout the summer, you'll contribute to meaningful projects that improve clinical site performance and regulatory readiness while developing analytical, organizational, and professional skills. WHAT YOU'LL DO Review regulatory and study documentation for completeness, accuracy, and filing consistency. Support Trial Master File (TMF) and Investigator Site File (ISF) quality review activities. Identify missing documentation and assist with document tracking efforts. Review site regulatory document inventories and verify expiration dates for licenses, CVs, GCP training records, and related documentation. Develop and maintain quality metrics, scorecards, and tracking tools. Analyze site performance trends, protocol deviations, and operational data. Create regulatory filing checklists and support continuous improvement initiatives. Present project findings and recommendations at the conclusion of the internship. WHAT YOU'LL BRING Currently pursuing a Bachelor of Science degree in Molecular Cell Biology, Biology, Integrative Physiology, Biochemistry, Biomedical Science, or a related field. Strong attention to detail and organizational skills. Ability to maintain confidentiality and handle sensitive information appropriately. Strong written and verbal communication skills. Ability to manage multiple priorities and work independently with guidance. Interest in clinical research, healthcare, regulatory affairs, or quality systems, preferred. Proficiency with Microsoft Excel, including filtering, sorting, formulas, and Pivot Tables, preferred. Experience with Microsoft Word and PowerPoint, preferred. Strong research and information-gathering skills, preferred. WHAT YOU'LL GAIN Exposure to clinical research operations, regulatory documentation, and Good Clinical Practice (GCP) standards. Hands-on experience reviewing, organizing, and analyzing clinical quality and compliance data. Training in Trial Master File (TMF) and Investigator Site File (ISF) management, regulatory document review, and site quality processes. Development of analytical, project management, and professional communication skills. Opportunities to collaborate with experienced clinical research professionals and learn how clinical studies are managed and monitored. Experience creating quality metrics, scorecards, and data-driven recommendations. A meaningful project that prepares you for future careers in clinical research, public health, healthcare, regulatory affairs, or the life sciences industry. COMPENSATION Undergraduate Rate: $19.00 per hour DEADLINE TO APPLY December 11, 2026 Biodesix is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.