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Clinical Contract Associate Ii

$79,500 – $138,700 years
Not Disclosed
10 Nov. 11, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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