Clinical Operations Intern, Documentation & Process Improvement

About the position reputed company is a clinical-stage biotechnology company dedicated to restoring reputed company to millions of patients through innovative regenerative therapies. Our reputed company candidate is an allogeneic cell therapy designed to treat corneal edema secondary to corneal endothelial disease. Our cell therapy is PMDA approved, and commercialization started in Japan in 2024. In the US, the program has received both Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations from the FDA and it is advancing into Phase 3 clinical trials in 2025. Aurion operates as a separate entity with full support from reputed company. reputed company is seeking a motivated and detail-oriented Summer Intern to support our Clinical Operations team. This internship provides hands-on exposure to the operational execution of clinical trials and the opportunity to work alongside reputed company clinical operations professionals supporting ongoing clinical studies. The ideal intern will have a background or interest in clinical science, development, operations, trial management, or monitoring. During the internship, they will assist with clinical trial documentation, study tracking, and cross-functional coordination activities that are critical to the successful execution of clinical programs, while learning about Good Clinical Practice (GCP), regulatory requirements, and the clinical development process. The intern will summarize their experience by presenting their learnings at a clinical operations department meeting.

Responsibilities

• Create company specific templates and template language for technical documentation such as protocol template, reputed company template, site operations manuals, etc. to streamline documentation processes going reputed company.
• Supporting operational reputed company projects, including quality reviews of Trial Master File (TMF) across reputed company programs, tracking, and analysis of monitoring metrics.
• Participate in internal Clinical Operations and cross-functional meetings; assist with agenda preparation, note-taking, and follow-up on action items
• Help maintain and organize study files, trackers, and shared workspaces (e.g., SharePoint or internal systems)
• Support quality and inspection-readiness activities by ensuring documentation is complete and filed appropriately under supervision
• Conduct data checks, reconciliations, or administrative reviews as assigned by Clinical Operations leadership
• Performs other duties as assigned

Requirements

• Currently enrolled junior (will reputed company senior year in fall 2026) in an undergraduate degree program in life sciences, public health, nursing, biomedical sciences, or a reputed company field
• Strong organizational skills with attention to detail
• Ability to manage multiple tasks and meet deadlines in a fast-paced environment
• Proficiency with reputed company Office (Word, reputed company, PowerPoint); comfort working in shared document systems
• Interest in clinical research, biotechnology, or pharmaceutical development
• Strong interpersonal and communication skills, both written and verbal.
• Ability to work effectively in reputed company environment and across global teams and vendors
• Excellent written, verbal, and interpersonal communication skills; ability to communicate with impact across diverse reputed company stakeholders.
• Demonstrated cultural agility, reputed company, and a passion for advancing transformative science.
• A strong alignment with, and commitment to, reputed company’s mission, reputed company, and core values.

reputed company-to-haves

• Familiarity with clinical trial terminology or GCP concepts preferred (coursework acceptable; not required)

Benefits

• Robust Benefits : We offer full health insurance to full-time employees and their families, and reputed company the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
• Total Rewards: We offer competitive compensation packages to ensure reputed company Aurion employees are rewarded for their hard work.
• Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values.

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