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About the Role

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on advancing treatments for chronically and critically ill patient populations. We assist clinical research throughout the development lifecycle, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms.

Responsibilities

• Assist Business Development Operations and Clinical Trial Operations Management with the development of site budgets for Requests for Proposals (RFPs).
• Assist in preparation of overall site budget templates and payment schedules for awarded global trials.
• Manage budget review and negotiation during site start-up for assigned trials.
• Manage budget review and re-negotiation for trial changes and protocol amendments.
• Collaborate with Clinical Systems to set up and manage the site payment process in the appropriate system.
• Oversee study-level and site-level payments to ensure accuracy and timeliness.
• Review and verify applicable data reports for processing of trial subject milestone payments, per scope and contractual agreements.
• Manage the receipt, review, and processing of site and vendor invoices.
• Prepare all payment requests and collaborate with CTI Finance to ensure timely site payment.
• Communicate with trial sites regarding site budget negotiation, invoice corrections/clarifications, and status of site payments.
• Communicate with trial Sponsors regarding budget and payment parameters, status of site negotiations and communications, pass-through costs, and address Sponsor site budget or site payment-related inquiries.
• Manage Sponsor’s approval or supporting documentation for pass through costs/additional costs outside the parameters of the CTA/budget.
• Prepare reports for Finance Department about payments, outstanding invoices, or forecasts for sites payments.
• Collaborate with Finance to address any Sponsor inquiries related to Sunshine Act reporting or the provision of additional financial projections.
• Provide training, guidance, and support to other CTI associates engaged in budget negotiation and/or site payment related activities.

Requirements

• Excellent verbal and written communication skills.
• Excellent detail-orientation, organizational, record retention, and time management skills.
• Excellent decision-making and creative problem-solving skills.
• Excellent customer service and interpersonal skills.
• Ability to work independently.
• Proficient in the use of the laptop computer and software systems.
• Ability to understand, interpret, and explain complex financial requirements.
• Ability to interpret clinical trial protocol for all financial implications for site costs, ensuring inclusion in trial site budget.
• Knowledge of ICH Good Clinical Practices, country Regulatory and/or applicable tax regulations, and CTI/Sponsor SOPs.
• Familiarity and comfort with the use of Medidata CTMS for site payments.

Skills

• Medidata CTMS

Location

• Greater Cincinnati, OH region

Work Type

• Hybrid

Experience Level

• At least 1 year experience within applicable industry (e.g., pharmaceutical, CRO, clinical site)
• Prior experience negotiating site budgets and/or managing trial site payments as part of a CRO, pharmaceutical company, or clinical site

Education Level

• Bachelor’s degree in finance/ budgeting or allied health fields such as nursing, pharmacy, or health / natural science or an equivalent combination of education and relevant work experience.

Benefits

• Generous health benefits
• Vacation packages
• Paid parental leave
• Tuition reimbursement

About the Company

• CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations.
• We assist clinical research throughout the lifecycle of development, from drug concept to commercialization.
• CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms.
• For more information, visit www.ctifacts.com.