Medical Reviewer II

Job Summary

Providing timely assessment of clinical trial data, the part-time contract Medical Reviewer II will review safety-related data, monitor safety queries, and ensure adherence to regulatory guidance while working remotely.

Key responsibilities:

• Conduct in-house medical reviews of Case Report Forms (CRFs), including query resolution and quality assurance of data listings
• Manage activities of regional contract Clinical Research Associates (CRAs) and organize files and budgets for clinical studies
• Provide medical support for adverse event reporting and assist in the preparation of documentation for regulatory submissions

Required qualifications:

• Bachelor's degree with a related health science background; RN or clinical pharmacy experience preferred
• Minimum of 2 years of clinical practice experience and 1 year of drug safety experience preferred
• Strong critical thinking skills for adverse event data collection and assessment
• Ability to present accurate safety data effectively, both orally and in writing
• Proficiency in computer applications, including Windows, Word, and Excel