PRINCIPAL RESEARCH COUNSEL - LEGAL GENERAL COUNSEL (Newport Beach, CA, US, 92617) - Hoag

Salary Range: $96.9200 - $159.9300 /hour. Actual compensation may vary based on geographic location, work experience, skill level, and education.

The Clinical Research Counsel will provide direction and support for a broad range of legal matters within the areas of clinical trials, research, and development. This role will provide legal and strategic oversight and support for Hoag Hospital’s Clinical Research management and staff regarding biomedical focused research, to include issues regarding intellectual property, commercialization, grants, ethics and regulatory compliance.

The Research Counsel will oversee, manage and work collaboratively with external stakeholders including research sponsors, their legal and contracts teams and other relevant stakeholders in the clinical research process. This role will function as the subject matter expert related to contracting, budgeting, protocol development, informed consent, patient privacy, data sharing, and material transfer agreements, and more.  This will include drafting initial contracts and amendments, developing supporting documents, initiating policies, and compliance and regulatory guidance materials.

The role will work to protect Hoag’s legal interests and maintain its operations in compliance with applicable law.

Other responsibilities:

• Follow established organization and department policies, procedures, objectives, performance improvement
• Adhere to the workplace Code of Conduct and Research Compliance requirements.
• Identify and analyze legal issues, draft key documents, present clear recommendation and assure legal compliance.
• Develop and deliver training programs for staff on legal and regulatory aspects of clinical trials.
• Support the implementation of department-wide initiatives such as research process improvement efforts.
• Participate in required training and education programs.
• Participate in regular research staff meetings.
• Must be able to work flexible hours to meet study deadlines and requirements.

Education and Experience

• Juris Doctor from and accredited law school.
• At least 5 years of demonstrated experience in a law-firm or in-house legal department providing legal support.
• Excellent negotiating, interpersonal, business, contract drafting, and writing skills are required with a minimum of 5 years of related compliance and/or transactional experience.
• Previous experience working with commercial IRBs.
• Knowledge of patient electronic medical systems and CTMS or similar system
• In-depth understanding of current medical terminology applicable to clinical research field.
• Familiarity with FDA's Good Clinical Practice for clinical research.
• Knowledge of all components of clinical trials/studies.
• Ability to travel to multiple sites and attend off-site staff meetings, as needed.
• Life science or medical research experience preferred

Licenses Required

• Member in good standing with the California Bar.

Hoag is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Hoag is committed to the principle of equal employment opportunity for all employees and providing employees with a work environment free of discrimination and harassment. Hoag hires a diverse group of people in a manner that allows them to reach their full potential in the pursuit of organizational objectives.