Clinical Trials Contract Specialist

Summary

Join Natera as a Clinical Trials Contract Specialist and play a pivotal role in developing, negotiating, and managing clinical trial agreements. Collaborate with cross-functional teams, including Legal, study teams, and vendors, to ensure compliance with regulations and ethical standards. Draft, review, and negotiate various legal documents such as NDAs, CTAs, CSAs, SOWs, and ISAs. Serve as the primary point of contact for contract-related inquiries and maintain accurate contract records. Monitor contract milestones and deadlines, provide guidance to investigators, and mitigate risks. This remote position requires a Bachelor’s degree, 5+ years of clinical study experience, and 3+ years negotiating investigator site agreements.

Requirements

• Bachelor’s degree required; scientific discipline preferred
• Minimum of 5 years of experience working on clinical studies in biopharma, diagnostics, or medical device fields
• At least 3 years of experience negotiating investigator site agreements
• Familiarity with clinical Electronic Data Capture (EDC) systems
• Strong understanding of SOPs, ICH-GCP, and FDA regulations
• Proficiency in Google Workspace (gSuite), MS Word, Excel, and PowerPoint
• Strong analytical skills and ability to develop solutions to contractual issues
• Excellent negotiation, communication, and interpersonal skills
• Ability to manage a high-volume workload and meet project-specific deadlines
• Flexibility and independence in managing contract negotiations
• Collaborative mindset to interact with internal and external stakeholders

Responsibilities

• Support cross-functional initiatives with a focus on customer experience and business operations
• Collaborate with Legal, study teams, vendors, and sites to address contract concerns and ensure alignment for execution
• Draft, review, and negotiate Non-Disclosure Agreements (NDAs), Clinical Trial Agreements (CTAs), including Clinical Study Agreements (CSAs), Statements of Work (SOWs), Investigator Sponsored Agreements (ISAs), amendments, and related documents
• Ensure all agreements comply with FDA regulations, institutional policies, and ethical standards
• Serve as the primary point of contact for contract-related inquiries from internal and external stakeholders
• Maintain accurate and up-to-date contract files, databases, and tracking systems
• Monitor contract milestones and deadlines to ensure timely completion and avoid delays
• Provide guidance to investigators and study teams on contract-related matters
• Identify and mitigate risks associated with clinical trial contracts
• Participate in continuous improvement initiatives related to contract processes
• Performs other duties and special projects as assigned

Preferred Qualifications

• Experience with vendor management
• Experience with Investigator Sponsored Agreements (ISAs)

Benefits

• Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Natera employees and their immediate families receive free testing in addition to fertility care benefits
• Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more
• We also offer a generous employee referral program!