Intern CRA - FSO

Job Overview:

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

Summary of 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 (Minimum Required):

• Currently enrolled in or recently graduated from a degree program in life sciences, public health, statistics, computer science, pharmacy, or another related field.
• Demonstrated interest in clinical research, trial operations, statistical programming, or data management.
• Strong organizational and time-management skills.
• Detail-oriented with a commitment to high-quality work.
• Effective communication skills and ability to work collaboratively.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to handle confidential information with discretion.

Preferred Skills

• Familiarity with Good Clinical Practice (GCP) and clinical trial processes.
• Experience with CTMS, EDC platforms, or statistical software (e.g., SAS, R) is a plus.

Work Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements:

• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.

Learn more about our EEO & Accommodations request here.