Clinical Development Intern: Regulatory & Site Quality

Biodesix, Inc.; Louisville (CO); Sur place; USD 22 000 - 31 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Attention to detail

Organizational skills

Confidentiality

Written communication

Verbal communication

Independent work

Clinical research interest

Excel proficiency

Word proficiency

PowerPoint proficiency

Research skills

Formation

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

Outils

Microsoft Excel

Microsoft Word

PowerPoint

Description du poste

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.