Job Description

Job Description

Job Title: Clinical Contract Assistant

Location: Sylmar, CA (Preferred) | Plano, TX | Maple Grove, MN

Start Date: January 12, 2026

Duration: 12-Month Contract

Position Summary

The Clinical Contract Assistant will work under the direction of the Contracts Manager to support clinical contracting activities. This role applies general business knowledge gained through education or prior experience and contributes to the team through entry-level contracting and administrative tasks. The position has no supervisory responsibilities and is accountable for individual contributions. The successful candidate will follow standardized procedures to complete assignments, analyze routine information, meet deadlines, and support contract execution efforts. Clear and effective communication with internal stakeholders and external study sites is essential.

Key Responsibilities

• Create and negotiate contract amendments
• Prepare study-site-specific budget drafts
• Send initial contract and budget communications to invited sites within established timelines
• Conduct periodic follow-ups with study sites
• Submit finalized contracts for internal and external signatures
• Scan fully executed contracts and revised Investigator Agreements
• Upload documents to the electronic Trial Master File (eTMF) system and maintain accurate status notes
• Attend meetings and calls and provide regular status updates as required
• File and maintain hard-copy contracts
• Prepare NTA agreement templates and distribute to study sites
• Process licensing requests
• Support the Contracts Manager and Contract Associates with assigned tasks as needed

Required Qualifications

• Minimum of 1–3 years of related contracting experience
• Associate’s or Bachelor’s degree in Business Administration, a related field, or equivalent experience
• Experience with contract negotiations, document redlining, and analytical review
• Familiarity with grant and contract requirements, policies, and procedures, including:
• Clinical and AdvaMed Code of Ethics on Interactions with Health Care Professionals
• Knowledge of GCP, ICH, GLP, and applicable federal, state, and industry regulations governing clinical grants and contracts
• Experience ensuring compliance with regulatory and government requirements, including but not limited to:
• Sunshine Act
• Federalwide Assurance (FWA)
• Human Subject Protection training
• Clinical insurance requirements
• Demonstrated understanding of company policies, procedures, and functional practices
• Strong written and verbal communication skills, including interpersonal and organizational abilities
• Ability to effectively communicate with employees at all levels of the organization
• Strong attention to detail, time management, and ability to meet deadlines
• Proven ability to handle sensitive and confidential information with discretion
• Demonstrated ability to comply with applicable government regulations and company operating procedures
• Proficiency in personal computer applications, including Microsoft Word, Excel, and Access
• Ability to apply evaluation, originality, and problem-solving skills as needed

Preferred Qualifications

• Bachelor’s degree in Business Administration or a related field
• Experience working with a pharmaceutical or biotechnology sponsor
• Direct knowledge of sponsor-side clinical contracting and clinical research

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