Clinical Research Assistant (IM-Reno)

Item 9.B-August 5, 2011
To expedite and facilitate the PDQ review process, please send the PDQ and Org Chart electronically to for discussion and for initial review before routing PDQ for approval signatures.
Questions - call UNR Faculty HR at 682-6114
INSTRUCTIONS: See for complete instructions.
Incumbent(s) Name (if applicable): Joann Oches; New position
Position #(s): 16974; new
Current Title: Clinical Research Assistant (IM-Reno)
Current Range: 2
Department: Internal Medicine - Reno
College/Division: University of Nevada
School of Medicine (UNSOM/MDDN)
Account #(s): 1320-119-08IV; -001K
Action Proposed: (check all that apply)
( ) New position: Proposed Range:
Proposed Title:
( ) Title Change, Proposed Title:
( ) Proposed Reassignment from Range
to Range
(X) Revised PDQ only (no change in range or title) (add 2nd position number0
( ) Line of Progression (show titles below)
JCC (Current
or new HR
I certify that the statements in this description are accurate and complete to the best of my knowledge.
Employee’s Signature
I/we have reviewed the statements in this form and they accurately reflect the job assignments.
Immediate Supervisor’s Signature
Evan Klass
Chair, Internal Medicine - Reno
Thomas Schwenk
Vice president, Health Sciences / Dean, UNSOM
Approved for Salary Placement Committee review.
Pres / Vice Pres / Vice Prov Signature Jannet Vreeland
Vice Provost and Secretary of University
Action Approved by the President (Completed by Faculty HR):
Position #: 16974
EEO Code: 3H
CUPA Code: CM9505
Exempt: Yes or No Census Code: 330
Job Class Code: 76993
Range: 2
Effective Date: 8/1/2011
Approved Title:
Employee Signature
(Employee signs and sends to HR for personnel file after PDQ has been “final” stamped for approval)
Rev: 12/1/2008
Position Description – Clinical Research Assistant (IM-Reno)
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1. Summary Statement: State the major function(s) of the position and its role in the
university. Attach an organizational chart with positions, ranges, and names for the division
which reflects the position in it as well as those supervised in the department. (This section is
used for advertisement of the position.)
Under the supervision of the Associate Professor, Internal Medicine and Nutrition, who is the
physician for the patient, the Clinical Research Assistant coordinates the care of patients who are part
of a research protocol. The incumbent participates in the assessment, evaluation and retreatment of
patients enrolled in research protocols in the Internal Medicine Department at the University of
Nevada Reno School of Medicine (UNSOM) through the Practice Plan. The Assistant coordinates
Internal Medicine protocols and educates medical staff who will be administering the investigational
drugs. As necessary, the Assistant provides education to patients, families, and other members of the
health team.
2. List the major responsibilities, including percentage of time devoted to each. Provide
enough detail to enable a person outside the department to understand the job (percentage
first with heading and then bulleted information).
70% - Research and Data Management
 Conducts all research activities within an ethically based framework and in accordance with
good clinical practices, i.e., Federal, State, and Institutional regulatory requirements
 Assures subject safety
 Develops and/or evaluates new research protocols considering feasibility of conduct at the site
 Maintains ongoing communication with Institutional Review board (IRB) throughout all phases
of the trial
 Participates in informed consent process
 Prepares site for study initiation
 Coordinates ongoing conduct of study through to completion
 Coordinates all activities for study close out
 Facilitates timely completion of Clinical Trial Agreement (CTA) or Grant proposal
 Maintains test article accountability
 Manages financial aspects of the clinical trial
 Collaborates with other departments to plan and implement relevant aspects of the protocol
 Maintains study records according to Sponsor and/or regulatory requirements; documents and
manages data
20% - Budget Management
 Effectively participates as a team in budgetary guidelines and projects
 Manages financial aspects of the clinical trial including quarterly and annual updates as
 Oversees clinical research billing accounts payable, accounts receivable, and provide flow
sheets for active and closed clinical trials
 Provides contract negotiation budgetary analysis for clinical projects, updating as needed
10% - Compliance and Professionalism
 Actively supports the Department and University in accordance with University policies and
maintains competency
 Commits to efficient, effective quality care and service for patients, families, visitors, physician
and team members
 Communicates directly and honestly and uses complete and open communication in an
appropriate manner and in an appropriate setting
Position Description – Clinical Research Assistant (IM-Reno)
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Provides potential solutions and/or ideas when accompanied by criticism and problem
Participates in the development of the facility. Uses facility resources efficiently.
3. Describe the level of freedom to take action and make decisions with or without
supervision and how the results of the work performed impact the department, division and/or
the university as a whole.
Level of Freedom:
The individual works closely with the Chair of Internal Medicine on decisions associated with the
position, but must work independently, with initiative, and with some latitude in decision-making.
The decisions and judgments made by the position affect the quality of oncology research performed,
its compliance with the requirements of the protocol, and the ability of the Internal Medicine
Department to continue to participate in such research. Accurate and complete performance of the job
duties associated with this position is crucial to patient health. Failure to perform as expected could
result in substandard patient care.
4. Describe the knowledge, skills (to include cognitive requirement and verbal and written
communication), and abilities (to include task complexity, problem solving, creativity and
innovation) essential to successful performance of this job (in bullet format).
Knowledge of:
 Requirements of each protocol and ability to ask providers for assistance
 Determination, performance and/or scheduling of protocol required test and procedures
 Application of regulatory requirements including International Conference on Harmonisation
(ICH), Health Insurance Portability and Accountability Act (HIPPA), Occupational Safety and
Health Administration (OSHA), International Air Transport Association (IATA)
 Federal Guidelines for use of animals and human subjects in research, University IRB,
electronic records
 Coding requirements
 Medical records and consent laws
 Medical terminology
 Screen patients for eligibility for designated protocol
 Strong verbal and written communication skills including syntax, grammar, and spelling
 Working knowledge of computers, equipment and software used to perform duties including
Microsoft Word (including creating/editing tables, headers/footers, outlines, and other
formatting), Microsoft Outlook and Excel (including data entry, ability to create and edit
 Appropriate phone and customer service skills
Ability to:
 Adequately make judgments and decisions
 Meet unchangeable and uncontrollable deadlines
 Have a very high degree of attention to detail
 Multi-task, organize, and prioritize
 Work both as a team member and independently
Position Description – Clinical Research Assistant (IM-Reno)
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Perform other essential duties and responsibilities efficiently, accurately and safely
Use ICD-9 and CPT4 coding books
5. Describe the type of personal contacts encountered in performing the duties of the job.
Explain the nature and purpose of these contacts: i.e., to provide services, to resolve
problems, to negotiate.
UNSOM faculty, residents and
IRB and contracting research
organizations and their
Practice Plan employees;
MEDSchool Associates North
University of Nevada School of
Medicine employees
Reason for Contact
To communicate with in order to fulfill requirements of protocol
Clinical research organizations
and representatives
Government Agencies
Insurance Companies
Physicians, other health care
Patients, families, visitors
Reason for Contact
To communicate with to fulfill the organization’s requirements
Vendors, suppliers
To provide services and to communicate with in order to fulfill
To work alongside in same setting with some shared patients; to
work with staff to recruit patients; correspondence; trials
conducted on premises
To prepare common administrative paperwork; to work directly
with PIs who are on the study that are also UNSOM faculty
To communicate with in order to fulfill regulatory requirements
To communicate relating to shared patients, as required
To discuss shared patients; education and coordination of
activities relating to regulatory or other requirements
To provide instruction and assistance in participation for study;
ongoing education
To contract negotiation; discuss billing or payables
6. Indicate the minimum qualifications which are necessary in filling this position should it
become vacant. Please keep in mind the duties/responsibilities of the position rather than the
qualifications of the incumbent.
Minimum educational level, including appropriate field, if any.
Bachelor’s Degree from a regionally accredited institution in a science related field
Minimum type and amount of work experience, in addition to the above required
education necessary for a person entering this position.
Bachelor’s Degree and four years or a Master’s Degree and two years of experience
 IRB training or familiarity of IRB process
 Clinical or administrative experience in clinical trials
 EKG experience
Preferred Licenses or Certifications: None
Position Description – Clinical Research Assistant (IM-Reno)
Indicate any license or certificate required for this position.
Current Certificate in Pulmonary Resuscitation (CPR)
Collaborative Institutional Training Initiative (CITI) Certificate
(dealing with human subjects protocols)
International Air Transport Association (IATA) Certificate
(shipment of dangerous/biological products)
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