Summary
The Clinical Affairs Intern will be responsible for supporting the Clinical Affairs team with multiple projects surrounding the operational aspects of clinical trials. This includes a focus on maintenance of study files and records and contributing to regulatory compliance and quality assurance. The Clinical Affairs Intern will learn about and support a range of tasks in support of clinical studies. The Clinical Affairs Intern will also support the development of essential document templates and data review activities.

Essential Duties and Responsibilities
• Supports collection, review, and filing of essential documents and regulatory documents for clinical research sites
• Helps build out clinical affairs infrastructure and tools, like eTMF, CTMS, and EDC
• Executes projects related to clinical research site engagement and participation in clinical trials
• Contributes to writing and review of clinical process documents to build repository of essential document templates
• Performs other duties as assigned

Education/Experience/Skills
• Currently working on completion of a Bachelor’s or Master’s degree in a related field
• Ability to read, understand, and interpret regulations and clinical documents
• Proficient in Microsoft Office Word, Excel, and PowerPoint
• Ability to work with cross-functional teams as well as independently
• Desire to learn and contribute to a fast-paced team
• Ability to exercise independent judgment
• Strong verbal, interpretation, and written communication skills

Preferred Experience
• Previous experience working in human subjects research preferred

Benefits
• Practical experience with varied business activities
• Shadowing, mentoring, and training with experienced and accomplished professionals
• Competitive compensation
• Flexible schedule
• Collaborative and supportive work environment

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.