Associate General Counsel Senior, Clinical Research- Remote

Overview

This full-time remote position provides legal counsel and support for clinical research activities, including advising the National Center for Clinical Trials, Institutional Review Board (IRB), Office of Clinical Research, and Office of Sponsored Programs. The role involves ensuring compliance with regulations from the Department of Health and Human Services and the Food and Drug Administration, as well as managing clinical trial agreements and related contracts.

Responsibilities

• Provide legal advice on clinical research and IRB-related regulations and activities.
• Manage negotiation and drafting of clinical trial agreements, data use agreements, collaboration agreements, and other contracts related to clinical research.
• Develop and maintain contract templates and negotiation playbooks.
• Collaborate with industry sponsors, academic institutions, and healthcare systems to facilitate research agreements.
• Review grants and grant applications for legal risks and advise internal stakeholders on obligations.
• Provide counsel on investigatory matters related to clinical research and IRB.

Requirements

• Juris Doctor (JD) degree.
• Licensed attorney authorized to practice law in any U.S. state.
• Minimum of 7 years of experience representing healthcare entities, contract research organizations, pharmaceutical companies, or a combination thereof.
• Demonstrated ability to counsel on a variety of healthcare legal matters, with a focus on clinical research and IRB issues.
• Experience conducting legal research, drafting, and reviewing clinical research legal documents.
• Proficiency in drafting and negotiating clinical trial agreements, confidentiality agreements, data use agreements, and collaboration agreements.
• Strong organizational and project management skills to handle multiple legal transactions simultaneously.
• Specialized knowledge of local, state, and federal laws and regulations related to clinical research.
• Ability to integrate digital tools and artificial intelligence to enhance legal research and communications.
• Experience handling confidential and sensitive matters involving healthcare providers, pharmaceutical companies, management, and regulatory agencies.
• Excellent verbal and written communication skills with the ability to collaborate across all organizational levels.
• Ability to work effectively within a complex corporate system environment.

Compensation & Benefits

• Pay range: $99.75 to $159.60 per hour, based on qualifications, skills, experience, and training.
• Eligibility for premium pay such as shift differentials and on-call pay, depending on the role.
• Potential for incentive pay and annual performance-based increases.
• Paid Time Off programs.
• Health and welfare benefits including medical, dental, vision, life insurance, and short- and long-term disability.
• Flexible Spending Accounts for eligible healthcare and dependent care expenses.
• Family benefits such as adoption assistance and paid parental leave.
• Defined contribution retirement plans with employer match and financial wellness programs.
• Educational Assistance Program.

Note: Eligibility for benefits may depend on employment status (full-time, part-time, etc.).

Location

Remote

Additional Information

All responsibilities and requirements are subject to reasonable accommodation for individuals with disabilities. This job description does not encompass all duties that may be assigned; employees are expected to perform other job-related tasks as requested by leadership.