General Counsel

JOB SUMMARY

The part time General Counsel is responsible for corporate and legal affairs, including developing and implementing strategic partnerships with healthcare institutions, Sponsors and CROs. Provides comprehensive legal review of clinical trial agreements, legal arrangements, site-level partnerships, and healthcare/research regulations. This role ensures organizational compliance with federal and state regulations, including FDA regulations, HIPAA, employment law, and clinical trial agreements. The attorney will draft, review, and negotiate contracts with sponsors, CROs, and clinical research sites, while also advising internal stakeholders on regulatory risks and obligations. This position plays a key role in safeguarding legal interests, supporting innovation, and enabling compliant growth across Innovo’s research network and associated interests.

RESPONSIBILITIES

The role is crucial in protecting the company’s legal interests and mitigating risk. .

· Draft, review, and negotiate clinical trial agreements (CTAs), site agreements, and contracts with sponsors, CROs, and other third parties involved in clinical research activities.

· Advise on regulatory requirements related to FDA regulations, HIPAA compliance, Good Clinical Practice (GCP), and other industry standards.

· Provide legal counsel on employment law matters, including staff contracts, employee relations, and workplace policies.

· Collaborate with the clinical research team and other departments to ensure compliance with legal and regulatory requirements in clinical trials.

· Review and negotiate site-level partnership agreements, ensuring alignment with company goals and compliance standards.

· Monitor changes in clinical research regulations and healthcare laws, advising senior leadership on any potential impacts on operations and ensuring timely compliance.

· Assist in resolving any legal disputes or issues arising during clinical trials, ensuring they are addressed in a timely and efficient manner.

· Advise on internal policies and procedures related to clinical trial operations and regulatory compliance.

· Provide legal support for risk management strategies, identifying potential legal risks and advising on mitigation strategies.

· Conduct training and education for internal stakeholders on relevant legal issues, compliance standards, and best practices for clinical research, if requested.

· Perform other related duties as required to support the legal needs of the organization.

QUALIFICATIONS

· Juris Doctor (JD) degree from an accredited law school required. Licensed to practice law in at least one state. Ability to travel as necessary across Innovo site network and to industry conferences

· Minimum of 5 years of legal experience, with a focus on clinical research, regulatory compliance, healthcare law, and employment law.

· Strong understanding of FDA regulations, HIPAA, Good Clinical Practice (GCP), ICH guidelines, and other industry standards and regulations related to clinical trials.

· Experience drafting, reviewing, and negotiating clinical trial agreements (CTAs), site agreements, and other contracts within the healthcare and life sciences sectors.

· Knowledge of employment law and labor regulations as they relate to clinical research teams and operations.

· Ability to interpret and apply legal regulations in the context of clinical trials and clinical research operations.

· Strong organizational, time management, and multitasking skills, with the ability to manage competing priorities and deadlines.

· Excellent verbal and written communication skills, with the ability to communicate complex legal issues clearly and effectively to non-legal stakeholders.

· Proven ability to work cross-functionally with clinical research teams, executive leadership, and external stakeholders.

· Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, etc.) and legal research tools.

· Ability to maintain a high level of professionalism and integrity in a fast-paced, high-stakes environment.