Pre-Award Administrator, UNLV Research Administration, Office of Clinical Trials (FLEXIBLE WORK SCHEDULE)[R0150617]

Nevada System of Higher Education•Las Vegas, NV

26d

About The Position

ROLE of the POSITION Research is a vital mission of a university and this position exists to assist and serve faculty and staff in seeking, negotiating, and managing clinical trials, including all pre-award activities. The position is responsible for managing all pre-award financial and administrative activities for industry-sponsored and investigator-initiated clinical research studies. This role supports investigators and study teams by developing and negotiating clinical trial budgets, coordinating proposal submissions, ensuring regulatory and institutional compliance, and facilitating timely study start-up. This position is also responsible for cost management and financial integrity of public funds and serves as point of contact for liaison between the University and clinical trial sponsors, federal agencies, foundations, industrial firms, state and local agencies. This position performs work under general supervision, with increasing independence as experience/expertise is gained/demonstrated.

Requirements

Knowledge of the functional areas of sponsored program administration (preaward and postaward) and a good general knowledge of the nature of research in all academic disciplines with familiarity with clinical research or clinical trial environments (e.g., sponsored; investigator-initiated, sponsor-investigator).
Knowledge of basic principles of sponsored project budgeting, including cost development and budget documentation and the ability to interpret policy with guidance as appropriate.
Good interpersonal and communication skills.
Organizational and independent working skills.
This position requires a Bachelor’s Degree from an accredited college or university as recognized by the United States Department of Education and/or the Council on Higher Education Accreditation (CHEA) and previous experience with budgeting/financial management.
Fundamental understanding of IRB processes as they relate to clinical trials is also required.
Credentials must be obtained prior to the employment start date.

Nice To Haves

Experience in developing budgets, billing grids, and internal cost summaries, as well as reconciling project budgets, preparing budget reports, adjustments and corrections to projected budgets.
Familiarity with federal regulations and compliance requirements applicable to sponsored research, or the ability to learn and apply such requirements with guidance.
Experience assisting with budget development, financial tracking, or reconciliation activities for sponsored projects or clinical research.
Working knowledge of applicable policies, Federal and State regulations, and industry standards relating to contract authority, use of human subjects, Code of Federal Regulations (CFR), Good Clinical Practices (GCP), International Council on Harmonization (ICH) guidelines, research regulatory compliance requirements, European Union (EU) directives and regulations, subject injury and indemnification, intellectual property, copyright and patent law, confidentiality, publication rights, Federal privacy laws, access to records, appropriate overhead rates, coverage analysis, record retention requirements for FDA-regulated clinical trials, and the ability to develop expertise on many such policies, regulations and industry standards.
Knowledgeable of major funding sources and their policies and procedures.
Experience in an academic medical center or large research institution
Knowledge of federal and state research compliance requirements
Certification in research administration (e.g., CRA, CCRC, CPRA)
Previous experience in Clinical Trials.
Three (3) years of progressively responsible experience in research administration, clinical trial financial management, or related financial/analytical work in a complex, regulated environment is preferred.

Responsibilities

managing all pre-award financial and administrative activities for industry-sponsored and investigator-initiated clinical research studies
developing and negotiating clinical trial budgets
coordinating proposal submissions
ensuring regulatory and institutional compliance
facilitating timely study start-up
cost management and financial integrity of public funds
serves as point of contact for liaison between the University and clinical trial sponsors, federal agencies, foundations, industrial firms, state and local agencies
providing financial services for clinical (drug and/or medical device) trials and other extramurally-funded clinical research projects, such as pre-clinical and observational studies.