Clinical Trial Budget & Contract Manager

The Clinical Trial Budget/Contract Manager plays a critical role in facilitating a smooth and efficient study initiation process by collaborating with Sponsors/CROs, Principal Investigators, study teams and ancillary services to ensure timely and accurate budget and contract execution. The Clinical Trial Budget/Contract Manager is responsible for the development, review, and negotiation of clinical research study budgets, interpreting coverage analysis to determine where study costs should be charged, ensuring consistency in research pricing and payment terms and harmonization amongst coverage analyses, budgets, contracts, and consent forms.

This role is pivotal to maintaining consistency in research pricing, and compliance with institutional and regulatory standards.
* Build and negotiate clinical trial budgets and contract terms, on behalf of faculty and the Departments/Divisions/Stanley Manne Children’s Research Institute, with industry, federal, and private funding agencies. Evaluate budget requirements and constraints to ensure the financial health of the organization.
* Read, analyze, and interpret clinical trial study documents including Protocol, Coverage Analysis, Budget, Contract, Informed Consent, and Laboratory/Imaging Manual, etc.
* Ensure document harmonization and compliance, and facilitate timely execution of agreements.
* Advise Department/Division faculty and staff on matters related to clinical trial budgets and contracts in a clear and professional manner.
* Successfully interact with other departments, ancillary support facilities, and administrative offices to ensure efficient operation at all levels.
* Establish professional relationships with pharmaceutical/device/biotech, CRO, and non-profit counterparts to facilitate amicable and timely negotiations.
* Track data related to study start-up through the clinical research billing compliance processes.  Contribute to data analysis, using established and novel metrics, to advance Division and Department efficiency and profitability.
* Manage multiple concurrent projects, paying special attention to competing deadlines, complexity, and priority.
* Monitor processing of Institutional Review Board (IRB) submissions and approval of clinical trial protocols.
* Work closely with the Clinical Trial Budget & Feasibility Specialist on intake of all new clinical research studies to initiate the process for financial and administrative viability review.  Works closely with the Principal Investigator and study staff in coordinating activities and follow-up associated with determining the feasibility of potential new clinical research studies.
* Collaborate with Investigators, study teams, appropriate internal departments, and 3rd party vendors through the budget development process to ensure budgets meet internal and external deadlines as well as the needs of the Institution and external funding agencies.
* Communicate with regulatory and contract staff to facilitate necessary language changes.
* Represent OCCT on institutional committees and work groups which focus on issues relating to research budgets, coverage analysis, and billing workflows.
* Other job functions as assigned.
* Bachelor’s Degree Required. Master’s degree and/or certification through Association of Clinical Research Professionals (ACRP), or Society of Clinical Research Associates (SOCRA), Certified Research Administrator (CRA)/Certified Financial Research Administrator (CFRA) preferred.
* Minimum of three years of work experience involving clinical trials, grant/research administration experience in a hospital, university or other research setting preferred.
* Experience with clinical trial budgets, clinical trial financial management, clinical trial agreements, and/or clinical research regulatory management strongly preferred. Strong budget development/analysis and negotiation skills.
* Knowledge of, and practical experience with, CPT codes, medical terminology, charge masters, and general research administration principles strongly preferred.
* Strong verbal and written communication skills in order to address large, diverse audiences. Ability to work independently and as a member of a team and follow through on assignments with minimal direction required.  Self-driven project management skills.
* Solution oriented with proven record of managing large scale research projects with diverse complexity required.
* Ability to quickly reason with information to solve new, unfamiliar problems, independent of any prior knowledge.
* Exceptional ability to distill complex clinical research protocols and related budgetary terms, so it is understandable to the lay audience.
* Ability to handle high volume of work with changing priorities and constant interruptions and establish priorities and deadlines required.
* Personal computer skills; functional experience with integrated software systems and proficient in Microsoft Office applications.

At Lurie Children’s, we are committed to competitive and fair…