(USA), Plano, TX, Maplegrove, MN

Role Summary

Working under the direction of a manager or senior contracts associate, the Clinical Contracts Associate provides technical assistance in developing, negotiating, reviewing, and processing clinical study and research contracts and budgets. This role solves problems in straightforward situations using technical experience, judgment, and precedent, and is capable of routine negotiations with limited supervision.

Key Responsibilities

•       Develops and negotiates contracts, contract amendments, and complex budgets with site partners within expected timelines and metrics.

•       Proactively collaborates with external and internal partners to address and resolve contract and budget issues to meet study milestones and deadlines.

•       Reviews informed consent documents to ensure alignment with contract terms and provides guidance to study teams.

•       Anticipates potential contract and budget compliance issues and takes timely action to mitigate risk.

Required Qualifications

•       Associate’s degree (or equivalent); minimum 4 years of related experience.

•       Knowledge of contract law and legal terminology; understanding of fundamental legal principles.

•       Familiarity with Google Cloud Platform, ICH, GLP, and applicable federal, state, and industry rules governing clinical grants and contracts.

•       Knowledge of grant and contract requirements including Sunshine Act, FWA, Human Subject Protection, and clinical insurance requirements.

•       Strong written and verbal communication, interpersonal, analytical, and organizational skills with the ability to meet deadlines.

•       Proficiency in Microsoft Word, Excel, and Access or equivalent applications.

•       Ability to handle sensitive and confidential information with discretion.

Preferred Qualifications

•       Bachelor’s degree in Business Administration or related field, or paralegal certificate.

•       5+ years of related experience in clinical contracting and budgeting.

•       Sponsor (pharma or biotech) experience with direct knowledge of clinical contracting preferred.

•       Demonstrated skills in redlining documents and analytical review.