Clinical Affairs Intern

ElephasMadison, WI
23h

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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