Clinical Development Internship (Undergraduate)

Biodesix, Inc.; Louisville (CO); On-site; USD 22,000 - 31,000; Full time

Job summary

Biodesix, Inc. is offering a Clinical Development Intern position in Louisville, CO. The role supports clinical site quality, regulatory documentation, and study performance under the Clinical Development team, providing exposure to GCP standards and regulatory processes.

You will contribute to meaningful projects, develop analytical and organizational skills, and gain experience in TMF/ISF management, regulatory review, and data-driven quality improvements throughout the summer.

Qualifications

• Pursuing a Bachelor of Science degree in a life sciences field.
• Strong attention to detail and organizational skills.
• Ability to maintain confidentiality and handle sensitive information.

Responsibilities

• Review regulatory and study documentation for completeness and accuracy.
• Support TMF/ISF quality review activities.
• Identify missing documentation and assist with tracking efforts.
• Review site regulatory documents and verify expiration dates.
• Develop and maintain quality metrics, scorecards, and tracking tools.
• Analyze site performance trends and regulatory data.
• Create regulatory filing checklists and support continuous improvement.
• Present project findings and recommendations at internship end.

Skills

Attention to detail

Organizational skills

Confidentiality

Written communication

Verbal communication

Independent work

Clinical research interest

Excel proficiency

Word proficiency

PowerPoint proficiency

Research skills

Education

Bachelor of Science in Molecular Cell Biology, Biology, Integrative Physiology, Biochemistry, Biomedical Science, or related field

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Job description

ABOUT US

Biodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients.

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.