Site Contracts Specialist

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Develop and tailor country-specific contract templates and site agreement documentation for initiating clinical trial activities.

• Oversee the negotiation of site contract language, budgets, amendments, and associated agreements until execution.

• Examine contract terms, study budgets, and related costs for precision, compliance, and adherence to approved guidelines.

• Collaborate with sponsors, clinical sites, legal teams, data privacy experts, regulatory bodies, and study teams to address issues and promote negotiations.

• Recognize and escalate contractual risks, budget issues, and site-related challenges.

• Perform quality assessments of contracts and related documents prior to signature and finalization.

• Manage the contract execution process and distribute fully executed agreements to relevant stakeholders and systems.

• Keep precise contract tracking tools and provide updates on negotiation progress, timelines, and deliverables.

• Balance competing deadlines and respond to urgent requests while supporting study startup goals.

⛳️ Requirements

• Bachelor's degree or equivalent in Business Administration, Finance, Science, or a related field.

• 1 to 3 years of experience in clinical research, pharmaceuticals, CRO, investigator/site contracts, or a related legal area.

• Proficient in English with outstanding verbal and written communication abilities.

• Familiarity with ICH-GCP guidelines, clinical trial regulations, and relevant local regulatory requirements.

• Experience in negotiating contract terms, budgets, amendments, and associated agreements with clinical research sites.

• Strong analytical and problem-solving capabilities, adept at identifying risks, resolving issues, and interpreting contractual and financial data.

• Proficient with Microsoft Word, Excel, and Outlook.

• Experience utilizing contract management systems and tools.

• Capacity to manage multiple priorities, work collaboratively across functions, and uphold a high level of accuracy and attention to detail.

🏝️ Benefits

• Competitive benefits package based on location.

• Transparent compensation and pay equity.

• Inclusive and equitable workplace.