Study Startup Research Administrator
Overview:
Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot.Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs. It’s located in one of the world’s safest and most economically vibrant communities and is Orange County’s second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.
To learn more about UC Irvine, visit www.uci.edu.
The UCI Alpha Clinic provides the necessary infrastructure, clinical and operational expertise to accelerate cell and gene therapies at UCI and throughout our communities. To accomplish our mission, we are working to achieve the following five goals:- Creating a Center of Excellence for cell-based therapeutics that addresses the unique challenges of testing and delivering novel cell therapies by integrating and building upon the extensive experience and many strengths of UCI and our partners.
- Building interactive and highly trained teams and electronic data sharing systems to accelerate and translate discovery to improve human health.
- Transforming the delivery of cell and gene therapeutics through our proven Good Manufacturing Practice (GMP) manufacturing.
- Advancing, expanding, and integrating educational opportunities to inform patients, families, communities, and clinicians of the full range of scientifically sound and medically appropriate, regulated cell and gene therapy clinical trials while providing objective information about potentially dangerous and unproven procedures.
- Serving as a regional, national and international resource for evidence-based best practices in cell and gene treatments.
Responsibilities:
The Study Startup Research Administrator (SSRA) is responsible for creating, negotiating, and monitoring budgets for clinical trials and grants, and regulatory coordination activities for UCI Alpha Clinic. They will work with the clinical trial team to create trial specific workflows and determine applicable regulatory requirements which may affect the budget.This role involves working closely with Principal Investigators, clinical research coordinators, Sponsors, Research Revenue Integrity and financial teams to identify resources, develop cost estimates for trial-related expenses, analyze protocols to identify potential budgetary impacts, developing tools to enhance accuracy, and ensure that trial budgets are accurate, compliant, and aligned with organizational objectives.
The SSRA will work with investigators, sponsors, internal departments, and external collaborators to determine applicable regulatory submissions, communicate requirements, and assure that applicable approvals are in place as part of clinical trials feasibility, site qualification, study conduct and study completion activities.
Responsibilities related to regulatory coordination activities include independently managing and preparing submissions for new studies, modifications, renewals, adverse events, and study closures to the Institutional Review Board (IRB), Food and Drug Administration (FDA) and other ancillary committees including, Institutional Biosafety Committee (IBC), and Radiation Safety Committee (RSC)
Qualifications:
Required:
- Thorough understanding of research administration guidelines of Federal and non-Federal sponsors supporting research and educational activities, preferably in a university environment.
- Thorough knowledge of applicable compliance requirements related to use of human or animal subjects in research, financial conflict of interest, biosafety, etc.
- Ability to manage significant volume of transactions.
- Ability to perform complex financial analysis and customized reporting.
- Demonstrated competence in the use of spreadsheet and database software in financial analysis, fiscal management and financial reports.
- Ability to maintain independent judgment; strong organization and communication skills; and a customer service focus across broad and diverse subject areas.
- Maintains current knowledge of compliance regulations in all areas of research administration.
- Demonstrated knowledge of generally accepted accounting, fiscal and reporting principles.
- Bachelor's degree in related area and / or equivalent experience / training
- 4-6 years relevant experience
Preferred:
- Demonstrated knowledge of effective grant funding processes, procedures and techniques
- Strong writing skills in a variety of styles to draft persuasive text for a variety of audiences while ensuring adherence to funding sponsor's guidelines.
Full salary range $63,800 - $111,600 [Expected pay range is between $69,500 - $83,000.00]
Total Compensation
In addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding. These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks.Please utilize the links listed here to learn more about our compensation practices and benefits.
Conditions of Employment:
The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community. As part of this commitment, all applicants who accept an offer of employment must comply with the following conditions of employment:
- Background Check and Live Scan
- Legal Right to work in the United States
- Vaccination Policies
- Smoking and Tobacco Policy
- Drug Free Environment
- California Child Abuse and Neglect Reporting Act
- E-Verify
- Pre-Placement Health Evaluation
Details of each policy may be reviewed by visiting the following page - https://hr.uci.edu/new-hire/conditions-of-employment.php
Closing Statement:
The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.
For the University of California’s Affirmative Action Policy please visit: https://policy.ucop.edu/doc/4010393/PPSM-20.
For the University of California’s Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination.
We are committed to attracting and retaining a diverse workforce along with honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming.
UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at (949) 824-0500 or eec@uci.edu.