Clinical Trials Administrator
Hyde Park Campus
About the Unit
In the Department of Pediatrics at the University of Chicago, we strive to provide the highest level of complex care for children from diagnosis and treatment to conducting research to find promising new therapies with a focus on teaching. We are committed to advancing the frontiers of knowledge, and the education and training of future clinical pediatricians, subspecialists, educators, clinical investigators and physician-scientists. Professional and investigative aspects of medicine are readily combined and the attributes of academic life are easily recognized in the Department of Pediatrics. Our faculty and staff value the designation "teacher of teachers" and appreciate the importance of research training, individual creativity and high quality comprehensive clinical care and service. The Department of Pediatrics is a dynamic, stimulating place to work, and because we are focused on growth and improved excellence, our staff have particularly challenging and rewarding roles.
In clinical research, scientific innovations are discovered through the path from the laboratory to real-word practice, leading to improved human health. The Clinical Trials Administrator within the Department of Pediatrics Research Administration Team supports this vision by initiatingand oversee administrative start-up activities for clinical trials including creating and negotiating clinical trial budgets with clinical trial sponsors.This position works closely with Principal Investigator's (PI's), administrators and study teams in the Department of Pediatrics Clinical Trials Office (CTO) to develop, coordinate and review all financial and administrative aspects of clinical trial agreements from execution to closeout. A passion for supporting clinical trial study teams, finance experience, attention to detail and a strong client service ethic are important in this role. Also develops budgets for studies funded by non-profits, federal or state agencies or other funding sources.
- Works directly with the faculty and research staff to seek new avenues for funding and new grant opportunities. Ensures that notices of relevant new funding opportunities for research programs are brought to the attention of the faculty.
- Collaborate with research study staff (Investigators, Coordinators, Administrators, etc.) to translate the study protocol into its financial equivalent by developing a clinical trial budget inclusive of all projected revenue and costs associated with trial (including start-up costs to adequately cover activity up to the point of contract execution).
- Complete an internal cost assessment (ICA), prior to developing and negotiating the external budget with funding source, in order to determine costs to perform the study, and building external budgets based on that knowledge.
- Act as a liaison on behalf of the department with University Central departments such as Office of Clinical Research, University Research Administration and Financial Shared Services and other academic departments to facilitate communications, ensure required document submissions, and resolve any contract issues.
- Initiate and conduct assertive win-win negotiations with companies and provide rationale for pricing decisions based on the established standards for pricing.
- Review and negotiate contract payment terms and amounts with business and industry sponsors.
- Reviews any amendments or modifications and update budget templates as needed with negotiation of costing with sponsors
- Gathers needed documentation and manages the execution of Subawards, Sponsored Consulting Agreements, and Subaward Amendments.
- Ensures all applications and submissions meet agency and University guidelines.
Post award duties:
- Read and develop a full understanding of the terms and conditions of the executed budget and payment schedule in order to set-up and effectively maintain the Visit Earning Tracking System (VETS) form.
- Organize a study initiation meeting for study research staff to make financial matters understandable. Review relevant documents (study budget, templates, contract), highlight contract performance, and review drafted VETS form for reimbursable expenses.
- Provide CTO with initial and interim financial projections based on estimated revenue determined by various scenarios for enrollment, in order to assist investigators with decisions regarding ongoing financial feasibility.
- Maintains accounts including oversight, reconciliation, and error correction. Submits cost transfers/ late cost transfers, as necessary.
- Create and submit invoices in a timely manner according to the executed study budget and payment schedule regarding study start-up, ongoing per patient revenue, and all other earned reimbursable items.
- Proactively and assertively follow-up with our research sponsors to ensure that invoices are paid timely in accordance with the terms and conditions of our executed budget and payment terms.
- Apply revenue management standards by promptly invoicing, collecting and ensuring that funds are deposited and recorded to the appropriate account.
- Work closely with the study team managers to manage effort and make adjustments as needed to ensure that sources of salary support align with the effort of faculty and study staff, all while in compliance with sponsor policy.
- Comply with the funding agency's reporting requirements (as applicable), and consistently provide study teams with ongoing reporting throughout the course of the study so that study teams are aware of funds available to support effort and other study related expenses going forward.
- Properly close-out studies in a timely manner in compliance with department, Division and University policy and the requirements of the funding agency, as applicable. Manage overdrafts in line with Divisional and University procedures.
- Train/support other team members as needed.
Performs other similar and related duties as required or directed.
Education, Experience, or Certifications:
- A bachelor's degree in business administration, finance, accounting, or related field preferred.
- Three years of finance, accounting, business operations or grant/contract administration experience, preferably in a healthcare, pharmaceutical industry or academic environment.
- Knowledge of general accounting standards, budgets and/or fiscal reporting required.
- Experience in one or more aspects of sponsored program administration/clinical trials administration in a University, pharmaceutical/medical device company or CRO for two years preferred.
Technical Knowledge or Skills:
- Excellent oral and written communication skills required.
- Strong financial and analytic skills with understanding of financial processes and controls including the reconciliation process required.
- Demonstrated attention to detail and exemplary organization skills required.
- Demonstrated ability to clearly communicate and discuss clinical trial budgets with research staff, sponsors, clinical research organization, department and university administrators. Demonstrate diplomacy, tact and professional demeanor required.
- Demonstrated client-service orientation with ability to create positive working relationships with other team members and other internal and external partners required.
- Ability to manage and prioritize multiple projects/tasks simultaneously required.
- Ability to learn changing technologies related to grants and contracts management required.
- Proficient use of computers; requires solid working knowledge of MS Office Suite (Word, Access, Excel) required.
- Experience negotiating financial contracts or agreements preferred.
- Knowledge of federal rules and regulations relating to research grant and/or contract preferred.
- Initiate and take a proactive approach to work preferred.
- Take ownership and accountability for the quality of their work product preferred.
- Research or grants education and/or certification preferred.
- Maintains collaborative, team relationships with peers and colleagues in order to effectively contribute to the working groups achievement of goals, and to help foster a positive work environment preferred.
- Maintains patient confidentiality per HIPAA regulations preferred.
The following documents are required to be considered for this position:
- Cover Letter
NOTE: When applying, all required documents, including cover letters, MUST be uploaded under the Resume/CV section of the application.
Depends on Qualifications
Scheduled Weekly Hours
Job is Exempt?
Drug Test Required?
Does this position require incumbent to operate a vehicle on the job?
Health Screen Required?
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