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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)
OUR PURPOSE & VALUES: Everything we do is about caring for our patients, our members, our students, 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, from senior management on down, we encourage an atmosphere of collaboration, cooperation and collegiality. We know that a diverse workforce with unique experiences and backgrounds makes our team stronger. Our patients, members and community come from a wide variety of backgrounds, and it takes a diverse workforce to make better health easier for all. We are proud to be an affirmative action, equal opportunity employer and all qualified applicants will receive consideration for employment regardless to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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.
At Geisinger, our innovative ideas are inspired by the communities we serve – like our Fresh FoodFarmacy, a program that delivers life-saving healthy alternatives to patients with diabetes. With additional tools like our MyCode Community Health Initiative, one of the first health system genome sequencingprograms, and our new asthma app suite that we developed in partnership with AstraZeneca, it’s no wonder we’re ranked one of the Top 5 Most Innovative Healthcare Systems by Becker's Hospital Review. We continually work towards continuous improvement in a culture where everyone has a voice and firmly believe that better begins with all of us.Founded more than 100 years ago, Geisinger serves more than three million residents throughout central, south-central and northeastern Pennsylvania and southern New Jersey. Our physician-led system is comprised of 30,000 employees, including 1,600 employed physicians, and consists of 1...3 hospital campuses, the Geisinger Health Plan, Geisinger Commonwealth School of Medicine and two research centers. What you do at Geisinger shapes the future of health and improves lives – for our patients, communities, and you.