Clinical Development Intern

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