Clinical Contracts Associate

SIRO; Plano (TX); On-site; USD 55,000 - 75,000; Full time

Job summary

SIRO is seeking a detail-oriented contract associate to develop and negotiate contracts and complex budgets with site partners. You will work with internal and external teams to meet study milestones and address issues under minimal supervision.

The ideal candidate has 1–2 years of related experience, familiarity with contract law, and strong analytical and communication skills to ensure regulatory alignment (GCP/ICH/GLP) across studies.

Qualifications

• Associates Degree
• Minimum 1–2-year related experience
• Experience with contract and budget in clinical study/ research environments preferred
• Knowledge of contract law and legal terminology
• Understanding of GCP, ICH, GLP and related regulations
• Familiarity with Sunshine Act, FWA, Human Subject Protection training

Responsibilities

• Under minimal guidance, develop & negotiate contracts, amendments and complex budgets with site partners within timelines/metrics
• Collaborate with external/internal partners to resolve contract/budget issues to meet milestones
• Review informed consents to align with contract and provide guidance to study teams
• Anticipate potential contract/budget compliance issues and mitigate risks

Skills

Contract negotiations

Budget development

Communication skills

Analytical skills

Redlining documents

Knowledge of contract law

Regulatory awareness

Education

Associates Degree

Bachelor’s degree in Business Administration or related field

Paralegal certificate

Tools

Microsoft Word

Excel

Access

Job description

• Working under the direction of manager or senior contract associate, provides technical assistance in developing, negotiating, reviewing, and processing clinical study and research contracts and budgets. Understands key business drivers and corporate clinical priorities; uses this understanding to accomplish own work. No supervisory responsibilities. Solves problems in straightforward situations; analyzes possible solutions using technical experience, judgment and precedents. Impacts quality of own work and the work of others on the team; works within guidelines and policies. Explains complex information to others in straightforward situations. Capable of routine negotiations with little supervision.

Key responsibilities:

• Under minimal guidance & supervision, develop & negotiate contracts, contract amendments and complex budgets with site partners within expected timelines/metrics
• Proactively collaborate with external/internal partners to address & resolve contract/budget issues to meet study milestones and deadlines
• Review informed consents to ensure alignment with contract/agreement and provide guidance to study teams
• Anticipate potential contract/budget compliance issues and timely risk mitigation

Required Education & Experience

• Associates Degree
• Minimum 1–2-year related experience

Preferred Education & Experience

• Bachelor’s degree in business administration, a related field, or equivalent. Sponsor Pharma of Biotech experience preferred. Direct knowledge of Sponsor Clinical Contracting preferred.
• 3-5 years related work experience in Clinical contract/budget or an equivalent combination of education & experience
• Associate/ Bachelor's Degree in Business Administration, a related field, or equivalent and/or Paralegal certificate.
• Negotiations/Skills in redlining documents and analytical experience or equivalent. Familiarity with grant and contract requirements, policies, and procedures including, but not limited to:
• Knowledge of contract law and legal terminology
• Understand fundamental legal principles & terminology
• Clinical and AdvaMed Code of Ethics on Interactions with Health Care Professionals
• Knowledge and understanding of GCP, ICH, GLP and other federal, state, industry rules and regulations governing technical aspects of clinical grants and contracts
• Ensure all required data from studies and sites to comply with regulatory and government requirements (Sunshine Act, FWA, Human Subject Protection training, Clinical Insurance).
• A demonstrated knowledge of the practices/procedures of the function, company polices, and programs.
• Demonstrated written and verbal communication, interpersonal, presentation, technical, analytical, statistical, organizational, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees.
• Consistently demonstrates the ability to understand and take effective approaches to varying levels of communication that would be most efficient and productive.
• Be able to demonstrate and use discretion in exercising work assignments and handle sensitive/confidential information in an effective manner.
• The demonstrated ability to understand and comply with applicable government regulations and company operating procedures, processes, policies, and tasks.
• Demonstrated personal computer skills including working familiarity with relevant word processing, database, and spreadsheet applications (i.e., Microsoft Word, Excel and Access).