Research Contracts Specialist

Overview

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

Responsibilities

• Draft, review, and negotiate research contracts in collaboration with legal and other system teams, including (as applicable) clinical trial agreements, data sharing agreements, sponsored research agreements, material transfer agreements, confidential disclosure agreements, consulting agreements, research participation agreements, and master service agreements as they relate to Research and Sponsored Projects.
• Coordinate and request the 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 ensure regulatory compliance.
• Create clinical research study budgets with study teams and negotiate with industry and other sponsors/external entities; guide 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 prior to 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.
• 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 key stakeholders.
• Provide risk assessment related to contractual language and financial success to study teams and leadership to support decision making.
• Monitor 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

• Bachelor’s Degree (Required).
• Minimum of 3 years’ relevant experience (Required).
  • Relevant experience may be a combination of related work experience and/or Master's degree obtained (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)
• Shift: Days (United States of America)
• Scheduled Weekly Hours: 40
• Worker Type: Regular
• Exemption Status: Yes

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.