The Clinical Research Contract Administrator is responsible for negotiating in accordance with organizational policies and playbooks, research agreements with an emphasis on assurances of confidentiality, indemnification protection, preserving publication rights, and protecting intellectual property rights on behalf of Children’s Hospital Colorado. Additionally, this position will provide supervision to the research contract specialist team.
Performs all contract negotiations associated with research proposals by reviewing and negotiating terms and conditions of industry sponsored research contracts and related agreements. Reviews and negotiates the legal language, terms, conditions, intellectual property, and publication rights in accordance with organizational policies and playbooks to protect the interests of the hospital and the principal investigator or lead researcher. Reviews and negotiates amendments to terms and conditions after original contract is executed.
Reviews, analyzes and negotiates the contract language of all industry sponsored agreements, state and federal awards, grants, and sub-award agreements.
Maintains working knowledge of federal food and drug regulatory agencies, federal inspection offices, national health institutions, state health and education departments as well as working knowledge of international research regulations and of offices related to research protection and integrity.
Identifies any problematic language that may require negotiation and/or input from other CHCO or campus partner office such as Risk Management, Privacy, Compliance. Responsible for escalation of stalled contract negotiations.
Identifies and assesses risks associated with contracts and define strategies to mitigate risks; assist in the strategic direction, design, development, and implementation of the contracts process.
Provides high-level legal consultation to the Office of Legal Affairs on specific complex matters, including, but not limited to, complex transactional matters with insurance payors, governmental entities, and other regulated parties, complex reimbursement activity under Centers for Medicare and Medicaid Services (CMS) and liaison activity with other campus and governmental entities.
Assists with development and implementation of institutional policies and procedures related to research projects requiring written contracts. Support growth of the contracts process by facilitating the design of contract processes, establishing metrics and identifying ways to enhance client service.
Develops and oversees the maintenance of contract management databases that report on the status of key contracting metrics, including all pending and executed agreements, including expiration dates, time to negotiate, etc.
Ensures compliance with federal, state and international research regulations.
Develops annual work plans used to achieve goals and performance metrics.
Assigns and reviews work, provides work instruction (OTJ or formal training) and develops team members. Evaluates performance of team members, providing continuous feedback. Manages discipline and performance issues; hires and fires team members. Identifies resource needs and develops recommendations for meeting needs.
Participates in leadership activities for division, contributing to the achievement of goals and objectives; evaluates team performance. Defines and maintains internal processes for function; establishes customer service standards and handles operational and customer service escalations for research contracting team.
Education: Bachelor’s degree is required.
Experience: Minimum of five (5) years of related contract negotiation and administration experience is required.
Experience with clinical research contracts is strongly preferred.
Additional Salary Information: As a Children’s Hospital Colorado team member, you will receive a competitive pay and benefits package designed to take care of your needs that includes base pay, incentives, paid time off, medical/dental/vision insurance, company provided life and disability insurance, 403b employer match (retirement savings), and a robust wellness program.
Internal Number: 67558
About Children's Hospital Colorado
Here, it’s different. Come join us.
Children's Hospital Colorado has defined and delivered pediatric healthcare excellence for more than 100 years.
Here, the nation’s brightest nurses, physicians, scientists, researchers, therapists and care providers are creating the future of child health. With an optimist’s outlook, a trailblazing spirit and a celebrated history, we’re making new strides every day.
We’ve been Magnet-designated three times by the American Nurses Credentialing Center and are consistently recognized among the nation’s top 10 pediatric hospitals by U.S. News & World Report.
As a national leader in pediatric care, we serve children and families from all over the nation. Our System of Care includes four pediatric hospitals, 12 specialty care centers, 400+ outreach clinics and 7,000 healthcare professionals representing the full spectrum of pediatric care specialties.
We need your expertise.
A career at Children's Colorado will challenge you, inspire you, and motivate you to make a difference in the life of a child. Here, it’s different. Do you have what it takes?
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