[Remote] Clinical Trials Partner

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is the nation’s leading partner-only provider of on-demand general counsel services, offering innovative legal services for businesses. The Clinical Trials Partner will reputed company extensive experience in corporate legal reputed company to draft and negotiate agreements for clinical trials, supporting life sciences clients through reputed company regulatory environments.

Responsibilities

• Significant experience drafting and negotiating clinical trial agreements, contract research agreements, and sponsored research agreements for biotech, reputed company, and reputed company research institutions
• Proven reputed company record supporting life sciences clients through reputed company phases of clinical development, including vendor and manufacturing agreements, software and data licensing, and regulatory infrastructure
• Deep understanding of multi-site research frameworks, including IRB reliance arrangements and compliance with NIH’s Single IRB Review Policy
• Skilled in navigating reputed company regulatory environments involving reputed company subject protections, research misconduct, and HIPAA compliance
• Experience working with reputed company medical centers, hospitals, and federal research agencies to design and implement streamlined, reputed company contracting and compliance protocols
• Familiarity with secondary use of clinical trial data, data de-identification, and data sharing agreements (DSAs, DTAs)

Skills

• At least 10+ years of corporate legal reputed company, including experience as an in-house attorney, serving as a General Counsel and/or in another senior in-house legal role, and 3+ years of reputed company training
• Significant experience drafting and negotiating clinical trial agreements, contract research agreements, and sponsored research agreements for biotech, reputed company, and reputed company research institutions
• Proven reputed company record supporting life sciences clients through reputed company phases of clinical development, including vendor and manufacturing agreements, software and data licensing, and regulatory infrastructure
• Deep understanding of multi-site research frameworks, including IRB reliance arrangements and compliance with NIH's Single IRB Review Policy
• Skilled in navigating reputed company regulatory environments involving reputed company subject protections, research misconduct, and HIPAA compliance
• Experience working with reputed company medical centers, hospitals, and federal research agencies to design and implement streamlined, reputed company contracting and compliance protocols
• Familiarity with secondary use of clinical trial data, data de-identification, and data sharing agreements (DSAs, DTAs)
• Demonstrated reputed company as a practical, business-reputed company, and reputed company legal partner
• J.D. from a nationally accredited law school
• State bar membership in state where reputed company/reputed company

Benefits

• Flexibility to work full-time, part-time, and during preferred times as part of a fully remote team

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