California Licensed Senior Clinical Research Counsel

Job Summary

Experienced legal professionals will find a full-time opportunity as a California Licensed Senior Clinical Research Counsel, responsible for drafting, reviewing, and negotiating clinical trial agreements while ensuring compliance with applicable laws and regulations, in a remote work environment.

Key responsibilities

• Negotiate clinical trial agreements (CTAs) for multi-site, multi-country trials, managing a high-volume contract portfolio
• Advise Clinical Operations and Regulatory teams on contracting risks, indemnification, and budget/payment terms, while identifying potential legal risks
• Ensure compliance of all clinical trial contracts with federal, state, and international laws, including FDA regulations and Good Clinical Practice (GCP) guidelines

Required qualifications

• Juris Doctor degree required
• Member of a State Bar Association, preferably California
• 10+ years of experience at a large law firm or in the legal department of a Life Sciences or Pharmaceutical company
• Demonstrated expertise in drafting and negotiating clinical trial-related agreements
• In-depth knowledge of federal, state, and international laws governing clinical research