Research Contracts Specialist

About the role

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

Job duties

• Drafts, reviews, and negotiates research contracts in collaboration with legal and other system teams, including but not limited to, 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.
• Coordinates and requests the establishment of research study awards for accounting, monitoring, and informational purposes.
• Performs coverage analysis for clinical studies, including billing determination review and Medicare coverage analyses to ensure regulatory compliance.
• Creates clinical research study budgets collaboratively with study teams and negotiates with industry and other sponsors/external entities. Guides in use of fair market value rates for external contracts, as applicable.
• Performs reconciliation between contracts, budgets, billing documents, and informed consent forms prior to full IRB approval to ensure all documentation is accurate and consistent prior to study startup.
• Maintains an understanding of current local, state, federal, and institutional regulations pertinent to research agreements, as well as industry best practices and trends related to clinical trials and sponsored research. Understands Geisinger legal and contractual standards and collaborates closely with other contract teams across the organization.
• Develops and implements best practices related to contract management and negotiation processes.
• Maintains active partnerships with the Office of Research Compliance, IRB Operations, Research Finance, Insurance Risk Services Corporate Office, Research Cores, Legal, Supply Chain and other key stakeholders.
• Provides risk assessment in terms of contractual language, and financial success to study teams and leadership for decision making.
• Monitors timelines and communicates with study teams and external partners to ensure goals can be met.
• Assist with the development, presentation, and implementation of educational materials related to research contracts operations for principal investigators, project managers, and study teams.
• Develops and reports research contracts metrics to research leadership.

Qualifications

• Bachelor's Degree (Required)
• Minimum of 3 years relevant experience (Required)
• Skills: Communication, Multitasking, Organizing, Research Regulatory Environment, Teamwork

Location & schedule

• Work from home (Pennsylvania)
• Shift: Days (United States of America)
• Scheduled Weekly Hours: 40
• Worker Type: Regular
• Exemption Status: Yes

Benefits

• Healthcare benefits for full time and part time positions from day one, including vision, dental and domestic partners
• Encourages an atmosphere of collaboration, cooperation and collegiality