Clinical Affairs Intern

ElephasMadison, WI
2d$20

About The Position

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.

Requirements

  • 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

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

Benefits

  • Practical experience with varied business activities
  • Shadowing, mentoring, and training with experienced and accomplished medical writers.
  • Competitive compensation.
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