Clinical Trial Budget & Contract Manager

Description

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.
Job Duties:

• 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 workgroups which focus on issues relating to research budgets, coverage analysis, and billing workflows.
• Other job functions as assigned.

Knowledge, Skills, and Abilities:

• Bachelor’s Degree.
• 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.
• 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.
• Personal computer skills; functional experience with integrated software systems and proficient in Microsoft Office applications.

EducationBachelor's DegreePay Range$76,960.00-$125,840.00 SalaryAt Lurie Children’s, we are committed to competitive and fair compensation aligned with market rates and internal equity, reflecting individual contributions, experience, and expertise. The pay range for this job indicates minimum and maximum targets for the position. Ranges are regularly reviewed to stay aligned with market conditions. In addition to base salary, Lurie Children’s offer a comprehensive rewards package that may include differentials for some hourly employees, leadership incentives for select roles, health and retirement benefits, and wellbeing programs. For more details on other compensation, consult your recruiter or click the following to learn more about our benefits.Benefit StatementFor full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes:Medical, dental and vision insuranceEmployer paid group term life and disabilityEmployer contribution toward Health Savings AccountFlexible Spending AccountsPaid Time Off (PTO), Paid Holidays and Paid Parental Leave403(b) with a 5% employer matchVarious voluntary benefits:

• Supplemental Life, AD&D and Disability

• Critical Illness, Accident and Hospital Indemnity coverage

• Tuition assistance

• Student loan servicing and support

• Adoption benefits

• Backup Childcare and Eldercare

• Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members

• Discount on services at Lurie Children’s facilities

• Discount purchasing program

There’s a Place for You with UsAt Lurie Children’s, we embrace and celebrate building a team with a variety of backgrounds, skills, and viewpoints — recognizing that different life experiences strengthen our workplace and the care we provide to the Chicago community and beyond. We treat everyone fairly, appreciate differences, and make meaningful connections that foster belonging. This is a place where you can be your best, so we can give our best to the patients and families who trust us with their care. Support email: