Senior Counsel, Assistant Vice President of Legal Affairs, Clinical Research & Regulatory Compliance

Job Title: Senior Counsel

Location: SBC Corporation

Department Name: General Counsel Office

Req #: 0000206242

Status: Salaried

Shift: Day

Pay Range: $175,000.00 - $295,000.00 per year

Pay Transparency: The above reflects the anticipated annual salary range for this position if hired to work in New Jersey.

The compensation offered to the candidate selected for the position will depend on several factors, including the candidate's educational background, skills and professional experience.

Senior Counsel, Assistant Vice President of Legal Affairs, Clinical Research & Regulatory Compliance

Job Overview:

RWJBarnabas Health, New Jersey s largest integrated academic healthcare system, seeks a highly experienced and detail-oriented in-house attorney to serve as Assistant Vice President of Legal Affairs with a primary focus on clinical research, research contracting, and regulatory compliance.

This position provides legal oversight for the negotiation and management of clinical trial agreements, grant-funded research contracts, and collaboration agreements with academic and industry partners. The successful candidate will bring deep expertise in FDA regulations, IRB processes, HIPAA compliance in research, and federal funding requirements related to biomedical and clinical research. This role partners closely with the Office of Research, IRB, Compliance, and Clinical Operations to support the health system s growing research enterprise. A minimum of 8 years of relevant legal experience in research law, healthcare regulation, or academic medical center legal affairs is required,

Reports to:

• The Senior Counsel, Assistant Vice President of Legal Affairs, Clinical Research & Regulatory Compliance reports directly to the Vice President of Legal Affairs.

Qualifications:

• Juris Doctor from an accredited law school
• Active license to practice law in the State of New Jersey or eligibility for in-house counsel licensure in NJ
• Minimum of 8 years of legal experience, including substantial experience with clinical research, FDA regulatory compliance, and research contracting
• Comprehensive knowledge of federal research regulations, including FDA, HHS, OHRP, and NIH guidelines
• Demonstrated ability to manage complex agreements and collaborate effectively with operational, academic, and compliance stakeholders,
• Experience supporting an academic medical center, research institute, or life sciences sponsor
• Working knowledge of intellectual property, technology transfer, and conflicts of interest in research

Essential Functions:

Clinical Research Agreements and Contracting

• Draft, negotiate, and review clinical trial agreements, research collaboration agreements, material transfer agreements, data use agreements, sponsored research agreements, and associated amendments
• Provide legal advice on budgeting, intellectual property, publication rights, indemnification, confidentiality, subject injury, and other key research contract terms
• Coordinate with investigators, research administration, compliance, and finance to ensure timely execution and alignment with institutional policies and sponsor requirements

Regulatory Oversight of Research

• Advise on laws and regulations applicable to human subject research, including FDA regulations -21 CFR Parts 50, 56, 312, and 812, the Common Rule - 45 CFR Part 46, and HIPAA Privacy Rule as it applies to research
• Support the Institutional Review Board in navigating complex regulatory questions involving informed consent, privacy protections, and multi-site trial oversight
• Counsel stakeholders on Good Clinical Practice, FDA inspection readiness, and compliance with ClinicalTrials, gov registration and reporting requirements

Grant-Funded Research Compliance

• Ensure institutional compliance with research-related components of the Uniform Guidance - 2 CFR Part 200, NIH Grants Policy Statement, and other federal and state funding agency rules
• Provide legal advice on cost allocation, effort reporting, and subrecipient monitoring requirements
• Assist in resolving audit findings, responding to federal inquiries, and guiding corrective action plans related to research compliance

Training, Policy Development, and Legal Operations

• Develop and maintain template research agreements and regulatory guidance materials
• Conduct legal training for researchers, IRB staff, and research administrators on evolving legal standards and institutional protocols
• Track and assess new federal and state legislative and regulatory developments affecting research and provide timely legal interpretation to stakeholders

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Benefits and Perks:

At RWJBarnabas Health, our employees are at the heart of everything we do. Driven by our Total Wellbeing promise, our market-competitive offerings include comprehensive benefits and resources to support our employees physical, emotional, financial, personal, career, and community wellbeing. These benefits and resources include, but are not limited to:

• Paid Time Off including Vacation, Holidays, and Sick Time
• Retirement Plans
• Medical and Prescription Drug Insurance
• Dental and Vision Insurance
• Disability and Life Insurance
• Paid Parental Leave
• Tuition Reimbursement
• Student Loan Planning Support
• Flexible Spending Accounts
• Wellness Programs
• Voluntary Benefits (e.g., Pet Insurance)
• Community and Volunteer Opportunities
• Discounts Through our Partners such as NJ Devils, NJ PAC, and Verizon
• .and more!

Choosing RWJBarnabas Health!

RWJBarnabas Health is the premier health care destination providing patient-centered, high-quality academic medicine in a compassionate and equitable manner, while delivering a best-in-class work experience to every member of the team. We honor and appreciate the privilege of creating and sustaining healthier communities, one person and one community at a time. As the leading academic health system in New Jersey, we advance innovative strategies in high-quality patient care, education, and research to address both the clinical and social determinants of health.

RWJBarnabas Health aims to truly make a unique impact in local communities throughout New Jersey. From vastly improving the health of local residents to creating educational and career opportunities, this combination greatly benefits the state. We understand the growing and evolving needs of residents in New Jersey whether that be enhancing the coordination for treating complex health conditions or improving community health through local programs and education.