Effective
Date
ER Code
Approved title/Grade
Title Code
Date Classified
Analyst Initials Job Number
_____________BR
(The above section will be completed by the Compensation Unit following review)
Job Description/Employment Requisition Form
In addition to completing this form, please provide a copy of the most current departmental organization chart as it relates to this
position, or reclassification. For reclassifications, please note the name and current title of the incumbent .
Name:
Department:
Proposed
Payroll Title (If
MSP, add grade
level):
Current
Payroll Title:
Employee ID:
Home Dept. # (6
digits)
Senior Clinical Research Coordinator
Title Code:
Senior Clinical Research Coordinator
Recommended
Working Title:
Supervisor’s
Name:
7889
Phone &
email:
New Position:
Yes
No
Significant. Duty
Changes:
Yes
No
Critical Position?
Yes
No
Per Diem Limited
Physical/Health
Screening Required?
Yes
No
Appointment Type
(select one)
Limited or
Contract End Date
Career
Contract
Replacement For:
Work days & hours:
Percentage
Time:
Campus Work
Location:
Dept. Contact
Phone & email:
Resume
Receiver:
Phone & email:
Job Summary
Provide a description of the overall purpose of the position. “Why does this position exist?”
Senior Clinical Research Coordinators independently coordinate and are accountable for the overall
administration of one or more clinical studies, typically requiring advanced-level knowledge and skills.
They may provide leadership to lower-level clinical research coordinators and/or other support personnel.
The position is responsible for, and critically important to the overall operational management of clinical
research activities. It has direct responsibility for implementing a diverse portfolio of research activities
for one or more studies which may include multicenter clinical trials (both NIH and industry-sponsored),
local investigator-initiated clinical trials, and/or programmatic clinical research activities, such as a clinical
database and biorepository. Positions at this level may perform expert and efficient integration of
multiple complex programmatic activities, applying a sophisticated medical knowledge base, substantial
leadership skills, effectively working with a variety of people and organizations at UCSF (clinicians,
investigators, clinical staff, administration, Committee on Human Research, human resources, contracts
and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), exibiting an in-depth
knowledge of specific programs.
Reporting to a Principal Investigator (PI) or Director, the incumbent may have central responsibility for
ensuring CHR approval and compliance, contract generation, negotiation and approval, subject
recruitment, appropriate study testing, and adequate enrollment of multicenter clinical trials, longitudinal
cohort studies, local investigator-initiated studies, and biorepository efforts; exercise strong administration
and management leadership of clinical research, strong research coordination, and may lead
experienced personnel to ensure optimal systems for efficiency, compliance, safety, financial oversight,
and contractual expertise in negotiations and execution, as well as create and implement quality
improvement processes. This is a position of leadership whose main purpose is to ensure that clinical
research commitments are met and that the programs maintain a reputation for excellence in all
activities.
Note: If this is a reclassification request or a replacement with significant changes, please
briefly describe (no more than 2 paragraphs) the significant changes that have taken place since the position was
last reviewed. Additionally, please provide a copy of the former job description for the position.
Key Responsibilities
List key functions and the estimated percentage of time spent performing each of the position’s. Indicate which
responsibilities are considered "Essential" to the successful performance of the job as defined by the EEOC:
“Essential functions are the basic job duties that an employee must be able to perform…You should carefully
examine each job to determine which functions or tasks are essential to performance.” The following website can
provide guidance: http://ucsfhr.ucsf.edu/index.php/dismgmt/article/1205
Example:
25% Essential/Yes - Administration:. Under general supervision, oversee all aspects of the administrative office;
Interact with university officials, faculty, staff and representatives from outside agencies; Assist in the preparation
and coordination of Federal and non-federal grant applications from initial submission to annual progress reports;
Prepare and track purchasing and payment authorizations
%
of time
Essential
Function
(Yes/No)
Key Responsibilities
(To be completed by Supervisor)
Research Operations Management:
 Develop project plans, interview key sponsors, and deliver tangible project
results
 Provide periodic status reports to project executives and coordinate
documentation and archiving of project deliverables
 Design and perform ad-hoc performance analysis of the projects and the
project staff
 Build flexible pricing and cost models to test recommended solutions
against a range of outcomes/scenarios within the clinic trials and research
projects
 Perform business process review, operational reviews and design and
implement workflow and controls
 Develop project-related presentation material for study
 Monitor key operating potential for risk to clinics, physicians, staff, and the
University (e.g., inappropriate marketing, poor hiring practices, etc.)
Clinical Trials Management:
 Determine interest of groups in trial participation, assess ability to execute
protocol safely and properly (analysis of infrastructure, staff, funding
needs), negotiate pre-trial agreement and budget, work with Research
Services Analyst and Industry Contracts to execute agreement, set up
ancillary departments, train staff, assign tasks, create documentation, and
ensure local and federal research law compliance.
 Provide ongoing staff training, ensure continued compliance, coordinate
amendment updates, maintain study files, ensure audit readiness, recruit
patients, and track enrollment; lead staff to ensure proper close-out of
studies, discuss subjects’ options, and ensure that documentation and
storage of study files meets legal requirements.
 Ensure optimal systems are in place to ensure compliance with regulatory
requirements for the safe conduct of clinical research. Ensure all CHR
documents are up to date.
 Oversee preparation of new CHR applications; arrange paperwork for
renewal of existing protocols; respond to CHR requests for revisions; and
coordinate protocol changes with study sponsors.
 Ensure reporting of protocol violations to study sponsors and reporting of
adverse events to the CHR in a timely manner.
Respond to requests and reviews of studies from sponsors, study
monitors, FDA, and other entities, including complex audits of study
performance.
Longitudinal Cohort Studies:
 Manage infrastructure before and during study execution, including
database management, space allocation, equipment procurement, and
specimen/sample storage and transportation; work with leadership to
ensure proper execution of studies.
 Manage activities for cohorts in various areas of studies and disciplines;
and for clinical trials in various disciplines.
 Collaborate with other Universities, clinical entities, and industry using
collected data to understand disease progression and predictors.
 May contribute to or lead scientific presentations and publications based
on study data collected.
 May contribute to the development of new grant proposals.

Risk Management:
 Protect the University from non-compliance and potential litigation by
ensuring contract compliance, meeting local and federal laws, and
ensuring compliance with hiring and supervision laws; implement
safeguards and proper compliance with federal and local regulations to
ensure audit prevention and success.
 Act as regulatory authority and advisor by training and educating
employees and advising leadership and PI’s.
 Manage audits.
 Help institute and maintain a Quality Improvement Process.
HR Management/Administration:
 Recruit and train clinical research coordinators in collaboration with
leadership.
 Mentor clinical research coordinators and assistants, and help them
successfully perform functions including recruitment, scheduling, visit
management, subject characterization, and data entry.
 Train in federal and local research laws and guidelines.
 Help manage personnel needs.
Financial Management:
 Oversee budgets, invoices, and reimbursements.
 Ensure billing is appropriate and accurate to avoid improper billing of
Medicare, private insurance, or patients.
 Guide subjects through financial process (private vs. federal trials and
their relationship to insurance reimbursement) to ensure accurate
payments are made and subject not held responsible
 Review budget reports on a monthly basis.
 Along with the PI, create and maintain the annual study budget, monitoring
all items posted on ledgers, and ensuring that future budget projections
are consistent with remaining funds.
 Responsible for ensuring that the use of research funding is in compliance
with funding agency protocols.
 Assist PI in grant development, focusing on budget development.
100%
(To update total %, enter the amount of time in whole numbers (without the % symbol - e.g.,
15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The
total sum should add up to 100%.)
Qualifications, Licenses and Certifications
Required Qualifications:
Qualifications that must be possessed by any candidate to be considered for the position. These qualifications will
be included in the job posting and will be used to screen applicants. Please include qualifications that are objective
and quantifiable such as years of experience required, educational degrees, etc.
Please list:
 Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools,
independently indentifying recruitment leads, implementing new strategies, and continually adjusting
strategies to meet current recruitment goals.
 In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and
complex visit structures.
 Project management skills to oversee the administrative operations of the clinical trials program; knowledge
of strategies for recruiting human subjects.
 Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated
interpersonal, verbal and written communication skills.
 Ability to analyze complex and non-routine issues requiring innovative solutions.
 Ability to operate effectively in a changing organizational and technological environment.
 Ability to assess and respond to audit risk; ability to develop project plans/schedules and motivate team to
meet deadlines.
 Ability to interpret and apply policies and regulations.
 Financial analysis skills; demonstrated skills in preparing and presenting financial and quantitative
analyses, including financial projections and budgets.
 Significant project and clinical trial management experience or progressively responsible experience in a
related position including regulatory and compliance responsibilities.
 Experience using database software, such as MS Access or FileMaker Pro.
Required Licenses and/or Certifications:
Licenses and certifications that a candidate must possess to be considered for the position.
Please list:

Certification by the Society of Clinical Research Associates or the Association of Clinical Research
Professionals.
Preferred Qualifications:
Qualifications that an ideal candidate would possess, but are not minimally required for a candidate to be
considered for the position.
Please list:



Fluency in spreadsheet software; ability to develop complex spreadsheets independently; demonstrated
skills in audit preparation, execution, and follow-up.
Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating
bodies.
Experience with grant application procedures, personnel documentation, contract generation and
subcontracting, preferably at UCSF.
Problem Solving
Please provide 2-3 examples of problem solving for this position as described below (please be brief: 1-3
sentences for each example).
Common problems solved by the employee:
 Developing appropriate training programs for clinical research coordinators and other research staff while
meeting federal and local laws and guidelines.

Teaching and training physicians on proper clinical trial execution.

Developing and maintaining required documentation for clinical trials.

Reconciliation of subject encounters with billing to ensure correct billing practices.

Prioritizing tasks for staff in order to meet enrollment goals, manage data, enter data accurately, and
resolve queries to meet contract obligations.
Less frequent and more complex problems solved by the employee:
 Study cost analysis, budget preparation/negotiation and fund allocation.

FDA, CHR, and NIH audit prevention, preparation, execution and follow-up.

Ensure proper operating procedures to meet governmental and local agency requirements for clinical trial
conduct.

Develop operating procedures to meet ancillary departments’ and program needs.

Anticipate potential risk/benefit ratio to patients regarding clinical trial participation; ensure patient safety
and prevent lawsuits.

Program development and resource allocation.

Analysis of staff, space, and supply needs to produce quality data and ensure patient safety.

Partner with leadership to identify and assess risk. Put systems in place to strengthen financial systems
and eliminate potential financial risk.
Problems/situations that are referred to this employee's supervisor:
 Clinical emergencies or clinical complications outside the scope of established protocols.
 Research grants are found to be in a deficit, and changes need to be made to the personnel and
expenditures on the research projects as a result.
Management of Funds:
Does this position require oversight or management funds?
If No: Please skip this section.
If Yes: Please complete the budget grid.
Describe the degree to which the incumbent is directly responsible for the management of funds. Indicate the
variety of funding sources under the incumbent’s control:
Type of Budget
Number of Budgets
Current yr. expenditures $
Discretionary funds (division reserves,
endowments, gifts, clinical trial residuals)
Contracts and Grants (direct annual)
Total
Supervision: Complete this section ONLY if the incumbent in this position performs at least 3 of the
responsibilities listed below in the supervision of 2 or more UCSF employees. Positions that give work assignments
to other employees and review their work products, but do not perform at least 3 of these functions are typically
LEAD positions, not supervisory positions.



Participates in the interviews and selects who should be hired;
Independently determines subordinates' performance ratings;
Recommends budgetary limitations the amount of subordinate merit increases, whom will be selected for
promotional opportunities, and whether to request the reclassification of a position;


Recommends to issue written warnings and suspensions and determines what discipline should be
imposed upon a subordinate;
Formulates and recommends a resolution to grievances or complaints.
Indicate employees supervised, job title and FTE.
Employee Supervised
Job Title
FTE %
The following employees have identical job descriptions:
Please follow your department's procedures for management review and then submit to Human Resources
(Signature below is only required for hard-copy retention within the department. Electronic submission does not
require signatures.)
Supervisor
Name:
Employee
Signature:
Supervisor
Title
Supervisor
Signature:
Date:
Date:
x
x
Pulling 0-20 lbs.
Walking
Pulling 21-30 lbs.
x
Pulling 31-60 lbs.
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Squatting
Pulling over 60 lbs.
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Bending
x
Waist Twisting
x
x
Hand/Arm
Body Positions
x
x
Pull
x
Standing
Fine finger manipulation
x
Gross manipulation
Simple grasp
Continuous 67%100%
Frequent 34%-66%
Activity
Sitting
Kneeling
Occasional 1-33%
Never
Continuous 67%100%
Job Title:__________________________________
Frequent 34%-66%
Activity
Occasional
1%- - 33%
Never
Addendum: Physical Job Requirements
x
x
x
Crawling
Power grasp
x
x
Repetitive hand/arm use
x
x
Climbing ladders
Loud noise
x
Reaching shoulder height
x
Reaching below shoulder height
Exposures
Climbing
Climbing stairs
x
Dust, fumes or gases
x
Chemicals or toxic
substances
x
x
Lifting 0-20 lbs.
Latex
x
x
Ability to differentiate color
x
x
Lifting up to _______ lbs. overhead
Lifting up to _______ lbs. above
waist
Lifting up to _______ lbs. below
waist
Verbal communication
Other
Lifting
Lifting over 60 lbs.
x
x
x
Operating motor vehicles
Use of protective
equipment
x
Carrying
Carrying 0-20 lbs.
x
x
Carrying 31-60 lbs.
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Carrying over 60 lbs.
x
Push
Pushing 0-20 lbs.
x
Pushing 21-30 lbs.
x
Pushing 31-60 lbs.
x
Pushing over 60 lbs.
x
Other:_________________
Carrying 21- 30 lbs.
x