Clinical Research Budget Analyst

About the Job

In clinical and translational research, scientific discoveries are moved along a virtual path from the laboratory into real-word practice, leading to improved human health. This position will be a part of the Clinical Trials Financial Services Team (CTFS). The primary responsibility of this position is to initiate and oversee administrative start-up activities for clinical trials. These activities can include building out the schedule of events in our clinical trials management system, working with Fairview to obtain research pricing, developing and negotiating budgets.

Work Location:

Remote

Clinical Trial Management System (CTMS) Specification Creation and Maintenance (50%)

* Conduct a thorough analysis of research protocols to determine the specific protocol-required procedures, tests and timing of each. This requires review of the high-level details of the schedule of events along with the specific information in the procedural/visit descriptions and may require communication with project managers.

* Create a schedule of events in the CTMS to reflect what is required by the protocol for accurate clinical trial data capture and financial tracking.

* Develop a study-specific Excel workbook and send to research staff to collect information as needed.

* Revise the CTMS calendar based on feedback from the study team or protocol amendments.

* Enter financials in CTMS system.

Pre-Award Duties (35%)

* Protocol review/ budget development/ support Senior Pre-award staff.

* Work with research study staff (Investigators, Coordinators, Project Managers, etc.) to review the study protocol and develop the study budget, including the procedure and labor costs (requires use of the OnCore (clinical trials management system).

* Obtain additional study related materials and contact sponsor for clarification as needed.

* Review study budget with research staff to ensure that all relevant study costs have been included.

* For industry-sponsored studies, review and negotiate contract payment terms and amounts with the sponsor.

* Ensure timely processing of all pre-award steps to avoid delays in starting trials.

* Compare protocol and contract documents for consistency.

* Act as a liaison with the Sponsored Project Administration (SPA) department and academic department finance/administration to facilitate communications, ensure document submissions, and resolve any contract issues.

* Update and maintain clinical trial contract and financial data in the OnCore system.

* Maintain metrics for pre-award activities.

Post-Award Duties (5%)

* Account initiation, project set-up, ongoing involvement during study conduct.

* Work to ensure a smooth transition between pre-award and post-award project phases, including transition to post-award accountants.

* Renegotiate payments from sponsor and process contract and budget amendments as needed.

Other (10%)

* Collaborate with fellow financial and contract administrators and others who work with clinical trials to develop best practices, standardize processes, document procedures, etc.

* Other duties as assigned.

From initial negotiations to eventual close-out, our dedicated team negotiates, analyzes, recommends and regularly reviews the financial components of a clinical trial. This enables the principal investigator and study team to respond to issues in a timely manner, often preventing cost overruns.

The pre-award budgeting and contract negotiation team:

* Maintains calendars and financial data in the CTMS

* Develops budgets to project trial costs.

* Negotiates agreements and financial plans for funding costs.

* Facilities contract approval.

Program/Unit Description

The Clinical Trials Financial Services (CTFS) team supports clinical trials by providing staff skilled in understanding and negotiating contracts, as well as providing financial management and oversight for clinical trials.

Qualifications

All required qualifications must be documented on application materials

Required Qualifications

* A bachelor's degree in a healthcare or business related field and two years of experience that may include contract/grant budget development, sponsor negotiation, clinical trial administration, clinical trial project management or a member of a clinical trial study team OR a combination of 6 years of education and relevant experience.

* Demonstrated problem-solving abilities and analytical skills.

* Ability to build effective working relationships with the CTFS team, sponsors, external service providers and research teams.

* Advanced Excel skills/experience (ability to link data and create complex worksheets used for clinical trials budget development).

* Attention to detail.

* Excellent written and verbal communication skills.

* Strong reading comprehension skills in order to understand research protocol.

* Willingness to learn medical billing policies and procedures.

Preferred Qualifications

* Experience with software used to manage clinical trials or experience with other technical software.

* Familiarity with relevant…