Responsibilities:
- Draft and negotiate Clinical Trial Agreements and other research agreements between the government client (NIH) and industry collaborators (biologic and drug product manufacturers), and/or between or among other key parties (CRO, site, etc.).
- Provide counsel on:
- FDA laws and regulations
- ICH
- GCP
- Intellectual property
- Access to data
- Ownership of data and specimens
- Safety reporting
- Participant privacy
- Liability
- Indemnification
- Confidentiality
- Human subjects protection
- General Contracts law
Requirements:
- Juris Doctor from an accredited law school required along with a State Bar membership.
- 3-5 years of experience working at CRO or in health services.
- Sound legal judgment.
- Excellent writing/drafting and verbal communication skills.
- Strong team player who excels in collaborate environment.
- Ability to set and manage priorities and quickly adapt to changes.
- Self-directed organizational abilities and proven high attention to detail.
- Ability to solve complex issues using professional creativity and problem-solving skills.
Job Type: Full-time
Schedule:
Work Location: Hybrid remote in Bethesda, MD 20817
