Intern University Program - Clinical Operations

Role Summary

The Clinical Research Intern will support planning, execution, and oversight of clinical trials across Clinical Operations, Statistical Programming, Data Management, Drug Safety, or Project Management. This internship provides hands-on exposure to operational, analytical, or data-focused aspects of clinical research and is designed for students or recent graduates interested in clinical development, trial management, or data-driven research. The position is on-site in Daytona Beach, Florida.

Responsibilities

• Assisting in the preparation, review, and maintenance of clinical trial documents (e.g., protocols, informed consent forms, case report forms).
• Supporting communication and coordination with clinical trial sites.
• Participating in data entry, tracking, and quality control activities.
• Helping prepare materials for regulatory submissions and ensuring compliance with applicable guidelines.
• Monitoring study progress, including enrollment tracking and visit schedules.
• Supporting statistical programming tasks such as data cleaning, validation, and generation of summary outputs.
• Assisting in the development and testing of data management tools and electronic data capture systems.
• Conducting literature reviews and summarizing findings relevant to ongoing studies.
• Performing administrative tasks to support the assigned team.
• Supporting internal audits or inspections readiness activities.
• Performing other duties as assigned to support the success and efficiency of the department.

Qualifications

• Required: Currently enrolled in or recently graduated from a degree program in life sciences, public health, statistics, computer science, pharmacy, or another related field.
• Required: Demonstrated interest in clinical research, trial operations, statistical programming, or data management.
• Required: Strong organizational and time-management skills.
• Required: Detail-oriented with a commitment to high-quality work.
• Required: Effective communication skills and ability to work collaboratively.
• Required: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Required: Ability to handle confidential information with discretion.
• Preferred: Familiarity with Good Clinical Practice (GCP) and clinical trial processes.
• Preferred: Experience with CTMS, EDC platforms, or statistical software (e.g., SAS, R) is a plus.

Additional Requirements

• Occasional travel to site locations; occasional travel domestically and internationally may be required.
• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to perform fast, simple, repetitive movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of the upper body and neck.
• Ability to access and use a variety of computer software developed in-house and off-the-shelf.
• Light to moderate lifting and carrying up to 15-20 lbs.
• Regular and consistent attendance; varied hours may be required.