Deputy Director, Clinical Trials Unit Job Description
SC CTSI BACKGROUND
The Southern California Clinical and Translational Science Institute (SC CTSI) is a $56.8M budget academic-community
enterprise with a base NIH grant through March 2015 to support, promote and accelerate scientific discoveries and their
application in real-life settings to improve human and community health and improve health care. SC CTSI is developing
new ways to advance cutting-edge medical research into technology and methods in many disease areas and conditions
to improve the health of the community and improve delivery of health care.
Established in 2010 among the now 60-member NIH-funded Clinical and Translational Science Awards (CTSA)
consortium, the SC CTSI is one of the largest institutes at USC, with scientist leaders at its helm, spanning 8 USC and CHLA
schools including Medicine, Pharmacy, Dentistry, Social Work, Law, Cinema, in partnership with Kaiser Permanente
Southern California, the Los Angeles County departments of Health Services and Mental Health, the Community Clinic
Association of Los Angeles County, and more than 30 community health organizations in greater Los Angeles to address
the specific needs of the urban and diverse patient populations.
To achieve its goals, SC CTSI provides infrastructure, services and training to support clinical and translational research
and catalyze formation of new translational research teams; and develops broad coalitions and partnerships at the local
and national levels to enable a transformation of the research environment. As a partnership among leading academic,
clinical and community health institutions and organizations in Los Angeles, SC CTSI contains all the intellectual, physical
and population resources needed to conduct high quality research directed at health problems the health problems of
urban communities.
PURPOSE AND SCOPE
The Deputy Director (DD) has a key role in the financial, administrative and business management of both USC
and CHLA CTU operations. The DD will jointly report to the CTU Medical Director (MD), and the CTSI Executive
Director (ED). This position manages directly or indirectly all non-clinical staff within the CTU. CTU
Administrative Managers report directly to the DD. The CTU Administrative Managers share overall day to day
operational and financial responsibilities for the activities of CTU sites.
The position will participate with the MD and ED in short- and long-term strategic planning for the CTU. Other
important duties will include allocating financial and personnel resources, writing and implementing new policies
and procedures for the CTU. The DD is responsible for personnel, payroll, financial and budget planning and the
facilities of the CTU. S/he will devote significant effort to the development and implementation of
operational/financial systems and standard operating procedures across CTU sites.
The DD will establish necessary business projections/models to evaluate the performance of the CRC and develop
data driven business model options to ensure the future solvency that is balanced with serving maximum number
of faculty with high quality service.
Responsibilities will include long-range budgeting with fiscal management of the funds awarded to the CTU from
the CTSI and other sources. The DD will provide overall direction and leadership for all business, administrative
and operational functions at the CTU sites. The CTU maintains an operating budget of $3.5 million provided
through funds from the CTSI, patient care reimbursements, and institutional support. The DD will manage the
administrative staff organization and look to continually improve operation and processes.
The position will participate as a critical member of the team with the MD and ED in short- and long-term
strategic planning for the CTUs. Other important duties will include allocating financial and personnel resources,
writing and implementing new policies and procedures for the CTUs. The DD is responsible for personnel, payroll,
financial and budget planning and the facilities of the CTUs. S/he will devote significant effort to the development
and implementation of operational/financial systems and standard operating procedures across all CTUs sites.
The candidate will establish necessary business projections/models to evaluate the performance of the CTUs and
develop data driven business model options to ensure the future solvency that is balanced with serving maximum
number of faculty with high quality service.
The CTUs DD will be a seasoned veteran in the field with high level leadership skills and experience in academic
research and clinical operations management. A thorough understanding of clinical research is required in
addition to sound business acumen.
ESSENTIAL DUTIES AND RESPONSIBILITIES
1) Overall oversight for USC and CHLA CTU Financial and Risk Management includes
a) Directs and advises annual CTUs budgets in excess of $3.5 million for executive management approval
b) Establish necessary business projections/models to evaluate the performance of both CTU enterprises.
Develop business model options to ensure future solvency that balances serving the maximum number of
faculty with high quality service.
c) Financial management and oversight processes for both CTU enterprises including forecasting demand for
CTUs services as part of the strategic assessment.
d) Work with Medical Director, Executive Director and CTSI executive leadership to develop creative services
and business models that foster and enhance industry collaborations.
e) Assess complex financial processes and practices in the CTUs. Design finance and accounting systems and
implement improvements where needed. Regularly assess the costs across sites and track financial and
utilization performance to projections.
f) Conduct risk assessment for financial controls, personnel policies, research compliance and patient
privacy. Form and implement risk mitigation plan(s) where needed.
g) Design, establish and implement appropriate cost accounting methodologies. Design and oversee the
implementation of a new budgeting process and the methodology for forecasting and tracking all sources
of funds.
h) Monitor and oversee NIH award spending. Build projections and ensure monthly reconciliation of
expenses for the CTSI program. Oversee compliance with all NIH and USC regulations and other agency
compliance requirements.
i) Work with Medical Director, Executive Director and CTSI leadership to develop strategies for attracting
philanthropy and other sources to diversify the portfolio of funding to the CTUs.
j) Establish checks and balances to ensure that revenue generated from services provided by the CTUs are
appropriate, optimized and compliant.
k) Ensure overall systems solvency for the accuracy of clinical research subject data in clinical study
management software including securing systems validation procedures and 21CFR11 compliance
l) Direct the development/maintenance of a corrective and preventive action procedure within the Quality
Management System approach
m) Directs the development/maintenance of quality control procedures for accurate CTUs clinical research
supplies accountability and maintenance including investigational product and ancillary unit
supplies/devices
n) Reviews Quality Control and Quality Assurance report to ensure adherence to quality controls policies
2) Executive Operational Management of USC and CHLA Clinical Research Operations ensuring operational
excellence within CTU research operations includes:
a) Identify where key processes and are missing (or inefficient) and develop new processes to best meet the
needs of the CTU, CTSI and other stakeholders.
b) Integrate administrative and business functions effectively of CTU sites.
c) Develop evaluative reports needed for planning and decision-making purposes on all aspects of CTU
operations and success. For example, the deputy director will identify, plan and oversee capital projects
such as renovations and equipment upgrades.
d) Evaluate business collaborations to optimize CTU shared resources including sharing personnel, service
contracts for equipment repair, and the purchase of supplies. The Deputy Director will oversee all aspects
of space planning and strategically identify potential areas of future clinical research services
development.
e) Work with investigators and the Clinical Research Office (CRO) at USC on securing industry supported
clinical studies including protocol/study budget development, feasibility assessment and resource
utilization needs.
f) Work with Program Director and CTSI leadership to develop creative operational models and functional
configurations to foster and enhance industry collaborations.
g) Direct the development and maintenance of applicable business projections/models to evaluate the
performance of the CTU including future solvency, customer service trends and personnel scaling
3) Direct USC and CHLA CTUs Human Resource Management
a) Effectively manages the human resources of the organization according to USC and CHLA (Hospital and
University) policies and procedures according to current laws and regulations
b) Determine the most appropriate organizational and administrative structure for the CTUs to meet its
short and long term needs.
c) Work collaboratively with the CTSI human resources and staff for human resources issues at the CTUs.
d) Promote a “service center” culture that ensures CTUs staff, maximally serve the needs of USC clinical
investigators and research participants.
e) Promote the professional development of CTU staff through available and appropriate intramural and
extramural training opportunities.
4) Direct CTU Grants Administration and CTU Contract Management Administration including:
a) Report on all sources of funds (NIH, institutional, industry, etc.).
b) Oversee pre-award submission processes including protocol costing and proposal submission
c) Oversee post-award accounting practices at CTU sites to insure that expenditures comply with applicable
NIH, Federal, SOM, and University policies and procedures.
5) Direct overall Community and Public Relations including:
a) Create and implement both a short and long term strategic plan for marketing and promotion of the CTUs.
b) Promote and market the clinical research coordination capabilities of the CTUs with internal and external
vendors.
c) Provide leadership, direction and productive member of the CTU Leadership Committee.
d) Assures both CTUs organizational mission, programs, products and services are consistently presented to
the community at large and USC and CHLA staff and stakeholders.
Supervisory Responsibilities
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Independently selects CTU personnel OR participates in the interviews and recommends who should be hired
Independently determines CTU personnel performance ratings OR recommends performance ratings
Independently decides within budgetary limitations the amount of CTU personnel merit increases, whom will be
selected for promotional opportunities, and whether to request the reclassification of a position, OR recommends
these actions
Has independent authority to issue written warnings and suspensions and determines what discipline should be
imposed upon a subordinate OR recommends such actions
Has independent authority to resolve grievances or complaints OR formulates and recommends a resolution to
grievances or complaints.
Recruit, interview and participate in the selection and hiring of CTU staff
Directs and manages business administration and clinical research operations of both CHLA and USC CTUs.
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Manages performance reviews of applicable CTU personnel
Provide guidance to support staff to ensure successful completion of on-going tasks, as well as multiple projects and
special assignments.
QUALIFICATIONS
To perform this job successfully, the desired candidate must be a seasoned director with leadership skills and executive
experience in academic research and clinical operations management including clinical trials, business administration,
marketing, compliance and financial operations for both inpatient and outpatient clinical research activities. Ten or more
years of experience in academic clinical research setting is required. A bachelor degree of business/finance,
science/healthcare or related field is required. Graduate degree is preferred. A bachelor degree of business, accounting,
finance or related field is required. Graduate degree is required. The requirements listed below are representative of the
knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions.
Education and/or Experience
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Ten or more years of experience in academic clinical research setting is required with three-five years
of experience in executive management
BS with a major in Accounting or a related filed and six years of experience in administrative analysis
or operations research; or an equivalent combination of education and experience.
Graduate degree (MBA, MPH, etc) is required
Skills and Abilities
In addition to a proven track record of providing superior operational, financial, and business leadership of a large clinical
research or research enterprise the following is required for this position:
 Leadership level experience with and superior skills in process improvement and change management
 Demonstrated experience in financial management, policy and procedures including pre and post-award
administration. Must be familiar with audits, control and accountability methodology
 The incumbent must have ability to establish and maintain cooperative relationships with faculty, staff,
administrators and students. S/he must possess the ability to work as part of a team collaborating with all
levels of staff and management within the University of Southern University and Keck School of Medicine as
well as build and maintain community relationships
 Superior skills in cultivating a customer service culture forged around operational excellence and Quality
Management Systems
 Experience in developing standardized evaluation, reporting, and financial management systems to support
decision processes
 Candidate must possess excellent written and oral communication skills. Candidate must possess analytical,
problem-solving skills
 Demonstrated ability to work independently and under pressure to manage multiple concurrent tasks and
responsibilities with changing priorities, while maintaining personal effectiveness
 Proficient in Microsoft Suite of productivity applications, such as Word, Excel, PowerPoint, Project, Outlook,
Access and Visio
 Ten years of experience in the clinical research environment. The incumbent should hold a BS with a major in
Accounting or a related filed and six years of experience in administrative analysis or operations research; or
an equivalent combination of education and experience. Graduate degree in business and/or finance is
preferred
 Must be willing to work with minimal supervision and provide supervision to upper and lower
management
 Must be willing to be innovative in a complex highly regulated field
 Must have working knowledge of advanced medical terminology and routine test specimen
requirements;
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Must have the ability to communicate and thrive in a dynamic, fast paced, high volume
research practice, yet still maintain the highest level of customer service for our patients and
laboratory/administrative/physician staff
Ability to represent the CTUs