Recruitment Number: 4336 Reports To: Working Title: Clinical Research Business Manager Cost Center: IR7445 Bargaining Unit: FLSA: E Job Code: 007223 Job Location: UCI Medical Center - Orange Percent of Time: 100% Work Schedule: 8am-5pm Appointment: Career
The Clinical Research Business Manager (BM) reports to, and is directly responsible to, the Assistant Director of the Clinical Trials Unit (Stern Center) for all clinical research finance, business development and marketing matters for the Stern Center, fulfilling the mission of the Chao Family Comprehensive Cancer Center, the University of California Irvine School of Medicine and the overall UC Irvine Health enterprise. The NCI-designated Chao Family Comprehensive Cancer Center (CFCCC) is a campus-wide multidisciplinary matrix organization whose goal is to promote and enhance cancer-relevant research and patient care at UC Irvine. The CFCCC provides research resources to its ~175 members engaged in research and offers multidisciplinary cancer care to its patients. The Sue and Ralph Stern Center for Cancer Clinical Trials and Research (Stern Center) within the CFCCC provides centralized services for protocol review, regulatory work, study management, coordination with internal and external partners on financial terms and arrangements, and oversees accounts receivable, financial projections and reporting on clinical studies. The principal roles of the BM are to independently manage the financials, contracts and amendments for the large portfolio of cancer-related clinical trials, and to create, establish and maintain a comprehensive business development and marketing plan for the increased recruitment of patients to clinical trials. In addition, the BM serves as a primary contact for Principal Investigators for on-boarding, provision of materials and development of Investigator-Initiated Trial budgets. The BM is the primary liaison to investigators, clinical research coordinators and researchers for communicating and training about the financial study resource requirements for clinical research trials. In addition, the BM develops, implements and maintains policies and standard operating procedures for the contractual negotiation and workflow for clinical research and serves as the primary liaison to the CFCCC's National Clinical Trial Network affiliates.
Bachelor's Degree with 7-9 years of experience in developing, implementing and controlling budgets from multiple funding sources with direct experience in financial management of industry- and federally-sponsored clinical trial contracts and grants, or an equivalent combination of education and experience. Demonstrated ability to manage finances for large and complex portfolio of clinical trials sponsored by both industry and federal sources including all invoicing for all financial deliverables. Demonstrated understanding of the protocol review and implementation process. Demonstrated understanding of the content and structure of a clinical protocol. Demonstrated experience with recruitment strategies and recruiting subjects to clinical trials. Ability to construct, draft, and negotiate subcontracts under UCI prime contracts. Ability to monitor subcontractor performance in conjuncture with UCI's principal investigator and ensure the timely close out of subcontracts. Demonstrated ability to facilitate the prompt close out of contracts by verifying the fulfillment of contract obligations and the submission of contract deliverables. As necessary, work with other central administrative units and extramural sponsors to resolve any outstanding contractual issues prior to close out. Experience working in a Clinical Trials Management System (CTMS). Demonstrated ability to work independently in financial analysis and problem resolution and in following through on assignments with minimal direction. Demonstrated ability to make sound decisions and employ effective problem-solving techniques. Demonstrated ability to manage a complex workload with changing priorities and frequent interruptions and to organize and prioritize fluctuating workloads. Skill in analyzing technical data, information and objectives; defining problems and needs; identify relevant issues, concerns, patterns, tendencies and relationships; formulating logical and objective conclusions; and recognizing alternatives and their implications. Demonstrated ability to apply and implement creative solutions to complex problems. Proficient in use of financial systems. Skill in development of detailed and sophisticated recordkeeping methods in order to maintain detailed records of all clinical research-related expenditures, accounts receivable, internal recharges, contract residuals. Experience in precise, predictive short- and long-range financial and resource planning management within a fluctuating environment. Strong analytical finance background in a research working environment. Knowledge of pertinent policies, procedures, regulations and requirements of State, Federal, and other agencies. Excellent skills to produce concise, logical and transparent analytical reports. Excellent interpersonal, organizational and time management skills. Ability to work both independently and as part of team. Ability to take initiative and demonstrate strong commitment to duties. Ability to think critically and to compile and analyze data. Ability to analyze problems, implement solutions and multitask. Ability to work within a deadline-driven structure. Ability to maintain strict confidentiality and to act and interact on sensitive issues with tact and diplomacy. Demonstrated experience in maintaining flexibility and adaptability while leading and implementing institutional change. High level of integrity and honesty in maintaining confidentiality. Foster and promote a positive attitude and professional appearance. Expertise with Microsoft Office Suite (Word, Excel, Outlook, Powerpoint).
Experience managing finances for oncology-specific trials. Experience negotiating contract and grant budgets with both industry and federal sponsors. Familiarity with Cancer Center Support Grant guidelines. Experience working in Forte's OnCore Clinical Trials Management System (CTMS). Complete knowledge of University accounting and finance principles, practices and procedures. Complete knowledge of University of California contracts and grants accounting and management principles and procedures. Experience working in a multidisciplinary matrixed work environment. Working knowledge of University policies and procedures related to clinical research administration.
Below are general guidelines on the position's physical, mental, and environmental working conditions. In accordance with applicable state and federal law, UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at (949) 824-0500.
Bend: Occasionally Squat: Occasionally Crawl: Not Applicable Climb: Occasionally Kneel: Occasionally Handle Objects: Occasionally Push/Pull: Occasionally Reach above Shoulder Level: Occasionally Sit: Frequently Stand: Frequently Walk: Frequently Use Fine Finger Movements: Frequently Carry/Lift Loads up to 25 Pounds: Occasionally Carry/Lift loads between 25-50 lbs: Not Applicable Carry/Lift Loads over 50 Pounds: Not Applicable Read/Comprehend: Constantly Write: Constantly Perform Calculations: Constantly Communicate Orally: Constantly Reason and Analyze: Constantly Chemical/Biological Agent: Not Applicable Construction Activities: Not Applicable Contact with Water/Liquids: Not Applicable Drive Motorized Equipment: Occasionally Confined Spaces: Not Applicable Elevated Work Location: Not Applicable Radioactive Materials: Not Applicable Temperature Variations: Not Applicable Gas System: Not Applicable
Other Working Conditions: May require after-hours and weekend work hours on deadline-driven projects. Requires occasional travel to Irvine Campus, Newport Beach clinic or other satellite locations.
Final candidate subject to background check. As a federal contractor, UC Irvine is required to use E-Verify to confirm the work status of individuals assigned to perform substantial work under certain federal contracts/subcontracts.
The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC nondiscrimination policy .
Since 1965, the University of California, Irvine has combined the strengths of a major research university with the bounty of an incomparable Southern California location. UCI's unyielding commitment to rigorous academics, cutting-edge research, and leadership and character development makes the campus a driving force for innovation and discovery that serves our local, national and global communities.