Sr. Clinical Contracts Associate - Plano, TX or Maple Grove, MN

Job Title: Sr. Clinical Contracts Associate

Duration: 12+ Months
Location: Plano, TX or Maple Grove, MN

Position Overview
Seeking a Clinical Contracts Associate to support the development, negotiation, review, and execution of clinical study contracts and site budgets. The consultant will work directly with clinical sites and internal stakeholders to resolve contracting and budget issues and support study timelines.

Responsibilities

• Develop and negotiate clinical site contracts, amendments, and budgets.
• Manage routine contract negotiations with limited supervision.
• Partner with internal and external stakeholders to resolve contracting and budget issues.
• Review informed consent documents for alignment with contract terms.
• Identify potential contract, budget, and compliance risks and support timely resolution.
• Ensure contracting activities meet study timelines and established metrics.

Requirements

• Associate’s degree or equivalent with 5+ years of related experience.
• Knowledge of contract law, legal terminology, and clinical contracting principles.
• Familiarity with GCP, ICH, GLP, and regulations governing clinical grants and contracts.
• Understanding of Sunshine Act, FWA, Human Subject Protection, and clinical insurance requirements.
• Strong negotiation, organizational, analytical, and communication skills.
• Proficiency with Microsoft Word and Excel.
• Sponsor-side pharma or biotech contracting experience preferred.
• Clinical site budgeting and document redlining experience preferred.