Contracts Specialist II - Military Veterans

JOB SUMMARY

The Contracts Specialist II drafts, reviews, and negotiates a broad range of research-related contracts and agreements with a moderate-to-high degree of complexity such as Clinical Trial Agreements and Sponsored Research Agreements, in accordance with federal, state, local laws, regulations and University and departmental policies and procedures. This position may perform some innovative drafting of templates. Additionally, this position will serve as a mentor to junior employees and provide training as needed.

PRIMARY JOB RESPONSIBILITIES

• Performs initial review of research-related agreements for University compliance; reviews incoming contract packages for completeness and availability of necessary information, and solicits additional information from interested parties when necessary; consults with necessary University personnel regarding the nature of each sponsored program and its unique impact on the legal language contained in the related agreement(s); uses standard contract language appropriately; conducts pragmatic analysis of legal, institutional, and departmental goals to determine how best to achieve desired results in the terms of the agreementÂ
• Competently drafts, reviews, negotiates, and executes clinical research contracts (such as Clinical Trial Agreement (CTA), Clinical Research Agreements, Master CTAs, subsite contracts, etc) in accordance with federal, state, and local laws and regulations and University and departmental policies and procedures, specifically those governing human subjects research
• Negotiates agreements with external sponsors and collaborating entities to the benefit of University; creatively solves problems posed in specific agreements by analyzing and interpreting federal and state law and University policies as well as information from other sources, such as senior staff; assesses contracts for, and ensures compliance with, University policy and state and federal regulations; coordinates the review of non-standard terms and conditions with the appropriate University offices, such as the Office of the General Counsel
• Independently manages workflow to achieve and maintain performance standards established by senior management; maintains all required written documentation and correspondence in the contract management database, and regularly updates said database with pertinent developments; monitors agreement termination dates, renewal and cancellation deadlines in contract management database
• Generates reports and performs other administrative tasks as assigned
• Provides training and guidance to junior-level employees
• Performs other duties as assigned

KNOWLEDGE, SKILLS AND ABILITIES

• Intermediate level of knowledge of federal and local law, regulations related to research, including the Uniform Guidance and Title 21 of the Code of Federal Regulations; generally accepted contracting and subcontracting practices and intellectual property law; generally accepted research administration practices
• Knowledge of University policies related to research administration, recent OIG audit findings and agency audit work plans
• Knowledge of rules, regulations, and guidance applicable to human subjects research, such as Good Clinical Practices (GCPs), HIPAA, FDA regulations, and AAHRPP requirements.
• Knowledge and familiarity with a broad range of agreements, as well as the mechanisms for modifications or amendments thereto
• Knowledge of contract law principles, negotiation theory, and rule interpretation principles
• Knowledge of IP protection and licensing principles
• Interpersonal/human relations skills
• Written and verbal communication skills
• Ability to maintain confidentiality

MINIMUM QUALIFICATIONS:

Bachelors or masters degree, supplemented with three (3) to five (5) years of related experience.

PREFERRED QUALIFICATIONS:

Juris Doctorate