JOB SUMMARY
The 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.
· 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.
BENEFITS (for full-time)
· Competitive salary
· Health insurance
· Dental insurance
· Disability insurance
· Life insurance
· Paid time off
· Vision insurance
WORKING CONDITIONS
This job operates in a remote environment with occasional site visits. This role routinely uses standard office equipment such as computers, phones, and scanners. Some flexibility in hours is allowed, but the employee must be available during the “core” work hours of 9:30 a.m. to 3:30 p.m. and must work 37.5 hours each week to maintain full-time status. Occasional evening and weekend work may be required as job duties demand.
The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc. Innovo Research is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Innovo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Innovo Research will not tolerate discrimination or harassment based on any of these characteristics. In addition, Innovo will provide reasonable accommodations for qualified individuals with disabilities.
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.