General Counsel
Behavioral Health Market Context
Apply Nowvia GoInhouse.com
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
- •10 more items(s)
Responsibilities
- •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
- •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
- •14 more items(s)
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