Clinical Contract Associate II
Locations: Sylmar, CA; Maple Grove, MN
Category: Medical and Clinical Affairs
Role Summary
The Clinical Contract Associate II provides technical assistance in developing, negotiating, reviewing, and processing clinical study contracts and budgets. Works under minimal supervision, understands key business drivers, and applies judgment to solve straightforward problems. No supervisory responsibilities. Impacts the quality of own work and supports team goals.
Key Responsibilities
Develop and negotiate contracts, contract amendments, and complex budgets with site partners within timelines and performance metrics.
Proactively collaborate with internal and external partners to address and resolve contract/budget issues to meet study milestones and deadlines.
Review informed consent documents for alignment with contracts/agreements and provide guidance to study teams.
Identify potential contract/budget compliance risks and implement timely mitigation strategies.
Apply knowledge of GCP, ICH, GLP, and other federal, state, and industry rules governing clinical grants and contracts.
Ensure data from studies and sites comply with regulatory and government requirements (e.g., Sunshine Act, FWA, Human Subject Protection, Clinical Insurance).
Handle sensitive and confidential information with discretion and professionalism.
Use personal computer skills to manage documentation, including Microsoft Word, Excel, and Access.
Required Qualifications
Education: Associate’s Degree (± 13 years).
Experience: Minimum 1 year of related experience.
Strong written and verbal communication, analytical, organizational, and interpersonal skills.
Ability to prioritize tasks, meet deadlines, and interact effectively at all levels of the organization.
Preferred Qualifications
Education: Bachelor’s Degree in Business Administration, related field, or equivalent; Paralegal certification is a plus.
Experience: 5 years in clinical contracts/budget management or equivalent combination of education and experience.
Knowledge of contract law, legal terminology, and fundamental legal principles.
Familiarity with clinical and AdvaMed Codes of Ethics, grant/contract requirements, and regulatory frameworks.
Negotiation skills including redlining documents and analytical problem-solving.
Direct experience with Sponsor Pharma or Biotech clinical contracting preferred.
Compensation
Base pay range: $79,500 – $138,700 (may vary by location)
Core Competencies
Clinical contract negotiation and budgeting
Regulatory compliance and knowledge of GCP, ICH, GLP
Risk assessment and mitigation
Communication, collaboration, and interpersonal effectiveness
Attention to detail, organizational skills, and confidentiality
Benefits
Training and career development programs
Tuition assistance
Competitive compensation, incentives, and retirement plans
Health care and wellness programs (medical, dental, vision, occupational health)
Paid time off
401(k) retirement savings with company match
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Siliguri |Illinois :
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China | Quarry Bay |Liaoning :
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Canada |Quebec :
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Brussels |Antwerp :
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Auckland |New Zealand :
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Madrid |Cebu Province :
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Manila |Croatia :
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Japan | Saitama |Tokyo :
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King Abdullah Economic City | Khulais | Riyadh | Rabigh | Najran | Jeddah |Kuala Lumpur :
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Kyiv |Lima Region :
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