Research Contracts Specialist

Overview

This role supports principal investigators, research teams, and internal customers by drafting, reviewing, and negotiating contractual agreements related to research projects.

• Work model: Work from home (Pennsylvania)
• Shift: Days (United States of America)
• Scheduled weekly hours: 40
• Worker type: Regular
• Exemption status: Exempt

Responsibilities

• Draft, review, and negotiate research contracts in collaboration with legal and other internal teams, including:
  • Clinical trial agreements
  • Data sharing agreements
  • Sponsored research agreements
  • Material transfer agreements
  • Confidential disclosure agreements
  • Consulting agreements
  • Research participation agreements
  • Master service agreements (as applicable to Research and Sponsored Projects)
• Coordinate and request establishment of research study awards for accounting, monitoring, and informational purposes.
• Perform coverage analysis for clinical studies, including billing determination review and Medicare coverage analyses, to support regulatory compliance.
• Create clinical research study budgets with study teams and negotiate with industry and other sponsors/external entities, guiding the use of fair market value rates for external contracts as applicable.
• Reconcile contracts, budgets, billing documents, and informed consent forms prior to full IRB approval to ensure documentation is accurate and consistent before study startup.
• Maintain knowledge of current local, state, federal, and institutional regulations pertinent to research agreements, along with industry best practices and trends related to clinical trials and sponsored research.
• Understand organizational legal and contractual standards and collaborate with other contract teams across the organization.
• Develop and implement best practices related to contract management and negotiation processes.
• Maintain active partnerships with Office of Research Compliance, IRB Operations, Research Finance, Insurance Risk Services Corporate Office, Research Cores, Legal, Supply Chain, and other stakeholders.
• Provide risk assessment to study teams and leadership regarding contractual language and financial success to support decision-making.
• Monitor study timelines and communicate with study teams and external partners to help ensure goals can be met.
• Assist with development, presentation, and implementation of educational materials related to research contracts operations for principal investigators, project managers, and study teams.
• Develop and report research contracts metrics to research leadership.

Requirements

• Education: Bachelor’s Degree (Required)
• Experience: Minimum of 3 years relevant experience (Required)
  • Relevant experience may be a combination of related work experience and/or a Master’s degree (Master’s Degree = 2 years relevant experience).

Skills

• Communication
• Multitasking
• Organizing
• Research regulatory environment
• Teamwork

Compensation & Benefits

Healthcare benefits for full time and part time positions from day one, including vision, dental, and domestic partners.

Location

Work from home (Pennsylvania)

Equal Opportunity

Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected category under applicable federal, state, and local laws.