Research Contracts Specialist

Geisinger; Pennsylvania; Hybrid; USD 65,000 - 90,000; Full time

Job summary

Geisinger is seeking a Research Contracts Specialist to support principal investigators by drafting, reviewing, and negotiating contractual agreements for research projects, including clinical trial agreements, data sharing agreements, sponsored research agreements, and master service agreements.

You will coordinate study awards for accounting and monitoring, and perform Medicare coverage analyses to ensure regulatory compliance.

Qualifications

• Bachelor's Degree required.
• Minimum of 3 years relevant experience.
• Skills in communication, multitasking, organizing, regulatory environment, and teamwork.

Responsibilities

• Drafts, reviews, and negotiates research contracts in collaboration with legal and other system teams.
• Coordinates and requests establishment of research study awards for accounting, monitoring, and informational purposes.
• Performs coverage analysis for clinical studies, including Medicare coverage analyses to ensure regulatory compliance.
• Creates clinical research study budgets and negotiates with industry and other sponsors.
• Maintains understanding of regulations pertinent to research agreements and collaborates with contract teams across Geisinger.

Skills

Communication

Multitasking

Organizing

Research Regulatory Environment

Teamwork

Education

Bachelor's Degree

Job description

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

Job Summary

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. Work is typically performed in an office environment. Accountable for satisfying all job specific obligations and complying with all organization policies and procedures. The specific statements in this profile are not intended to be all-inclusive. They represent typical elements considered necessary to successfully perform the job. *Relevant experience may be a combination of related work experience and/or Master's degree obtained (Master's Degree = 2 years relevant experience).

Position Details

Education: Bachelor's Degree- (Required) Experience: Minimum of 3 years-Relevant experience* (Required) Certification(s) and License(s): Skills: Communication, Multitasking, Organizing, Research Regulatory Environment, Teamwork

OUR PURPOSE & VALUES

Everything we do is about caring for our patients, our members, our Geisinger family and our communities. KINDNESS: We strive to treat everyone as we would hope to be treated ourselves. EXCELLENCE: We treasure colleagues who humbly strive for excellence. LEARNING: We share our knowledge with the best and brightest to better prepare the caregivers for tomorrow. INNOVATION: We constantly seek new and better ways to care for our patients, our members, our community, and the nation. SAFETY: We provide a safe environment for our patients and members and the Geisinger family. We offer healthcare benefits for full time and part time positions from day one, including vision, dental and domestic partners. Perhaps just as important, we encourage an atmosphere of collaboration, cooperation and collegiality. 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. Geisinger is committed to making better health easier for the more than 1 million people it serves. Founded more than 100 years ago by Abigail Geisinger, the system now includes nine hospital campuses, a 550,000-member health plan, two research centers and the Geisinger Commonwealth School of Medicine. With nearly 24,000 employees and more than 1,600 employed physicians, Geisinger boosts its hometown economies in Pennsylvania by billions of dollars annually. We offer healthcare benefits for full time and part time positions from day one, including vision, dental and benefits for domestic partners. Perhaps just as important, we encourage an atmosphere of collaboration, cooperation and collegiality. For more information, visit www.geisinger.org, or connect with us on Facebook, Instagram, LinkedIn and Twitter. * Does not qualify for J-1 waiver. We are an affirmative action, equal opportunity employer. Women and minorities are encouraged to apply. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of disability or their protected veteran status.