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| Overview |
| WORKING TITLE
Nurse
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PERCENT OF FULL
100
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DEPARTMENT/PROJECT OVERVIEW
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POSITION
OVERVIEW
Under general direction, incumbent coordinates clinical trials in the
Division of General Surgery in the area of minimally invasive
surgery. Incumbent participates in research program/grant
development and budget preparation. Incumbent is also
responsible for project implementation, data collection, and
quality assurance. The duties include: assisting with grant
development and budget; participation in pre-study investigator
and coordinator meetings; in-servicing floor nurses, as well as
clinical transplant coordinators about the studies; ascertaining
compliance and patient visits. The position requires the
clinical evaluation of patients, managing patient
immunosuppression under supervision, communicating with
community referring physicians, as well as providing
informational presentations to other registered nurses.
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SPECIAL
CONDITIONS OF EMPLOYMENT
Must have valid California RN license.
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EMPLOYEES
DIRECTLY SUPERVISED: Name, Payroll Title, Job Description #,
Status (career, casual, student), %Time
None
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EMPLOYEES
SUPERVISED THROUGH OTHERS: Name, Payroll Title
None
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| For use only by
Department HR Contact |
| IS BACKGROUND
CHECK REQUIREDNo
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IS C.O.I.
DISCLOSURE REQUIRED
No
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| IS PRE-PLACEMENT
PHYSICAL REQUIREDNo
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(Dept only)
REQUESTED HEERA
All Others, not Confidential
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(Central HR
only) APPROVED HEERA
All Others, not Confidential
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FUNCTIONS WITH CORRESPONDING TASKS |
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FUNCTION
NAME
(1.) Research Program/Grant Development and
Budget Functions |
%TIME
20% |
ESSENTIAL
True |
TASKS
Provide input to Principal Investigator
(P.I.) regarding new programs, assisting in
evaluating new and existing programs
including nursing personnel, scope of
services, resources, equipment, supplies and
costs. D/W/M
Assist in developing and writing concept
sheets for new research projects and grant
applications. As needed
Assist PI with writing NIH grant
applications. As needed. |
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FUNCTION
NAME
(2.) Project(s) Implementation |
%TIME
35% |
ESSENTIAL
True |
TASKS
Responsible for protocol integrity with
respect to patient eligibility, enrollment,
teaching and follow-up of all study subjects
in both inpatient and outpatient settings. W
Responsible for development and
implementation of budgets related to
clinical trials. Y
Assist in the development and submission of
clinical trials. Y
Evaluate and care for study patients in an
outpatient setting. W
Organize and chair monthly research team
meeting for all personnel involved. M
Direct the workload of staff, who assist in
carrying out the various clinical trials. D
Responsible for public relations with
sponsoring companies by representing UCSD. W
Attend site or other meetings to learn about
the protocols. Y
Provide consultation with making protocol
amendments where necessary prior to project
start. Y
Inform patients about the various study
protocols at appropriate times and assist in
enrollment. W
Obtain or coordinate obtaining consent to
studies. W
Assure proper tests are performed at study
enrollment to ensure proper eligibility. W
Act as liaison between pharmacy, principal
investigator and patients. Facilitate timely
and accurate institution of drug therapy. W
Identify disqualifying data to ensure only
eligible patients are enrolled. W
Act as liaison between housestaff and
faculty. D
Ensure that patients are not started on or
continue with disqualifying medication. W
Inservice for house officers and/or nursing
staff regarding study protocols. M |
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|
FUNCTION
NAME
(3.) Data Collection |
%TIME
25% |
ESSENTIAL
True |
TASKS
Maintain and complete the timely filling in
of all case report forms. D
Collect appropriate data from x-ray,
microbiology, virology, chemistry,
hematology, patient flow sheets. Facilitate
accurate and timely specimen collection for
in-house patients and out patient visits. W
Facilitate timely collection of medical
records for the sponsor review at site
visits, act as liaison for PI and sponsor. M
Identify and notify PI of study endpoints.
Able to recognize data endpoints. M
Coordinate proper collection of blood and/or
urine specimens, proper preparation
(spinning, decanting, freezing, when
necessary) and sending of specimens to
outside laboratories as necessary. W
Obtain consent for release of outside
medical records, as well as coordinate
collection of these records. W |
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|
FUNCTION
NAME
(4.) Quality Assurance |
%TIME
20% |
ESSENTIAL
True |
TASKS
Notify PI and/or sponsoring company of any
protocol violations and assist in correcting
problems to avoid future violoations. W
Continually evaluate the accuracy of data. D
Assure compliance with standards set by
human Subjects Committee. W
Coordinate drug accountability with the
pharmacy. W
Can identify and assure proper notification
of adverse event for Human Subjects
Committee and sponsoring company. W
Coordinate special tests in the event of an
adverse event. W
Meet regularly with sponsor's clinical
research associate for chart audits. M
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KNOWLEDGE, SKILLS, AND ABILITIES |
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RELATED FUNCS: |
DESCRIBE KNOWLEDGE, SKILL, ABILITY: |
IMPORTANCE LVL: |
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Clinically experienced
Registered Nurse. |
Required |
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At least three years
clinical experience (experience must consist
of at least one year in the field of
minimally invasive surgery and one year in
clinical research). |
Required |
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Working knowledge of
immunosuppression, including: compatible
combinations of immunosuppression
medications; mechanisms of action;
therapeutic monitoring and proper dosing;
drug-drug interactions; and side-effects, as
well as appropriate actions for those
side-effects. |
Required |
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Strong organizational and
administrative skills. |
Required |
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Ability to supervise/direct
work activity of others. |
Required |
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Strong knowledge related to
experimental protocol design. |
Required |
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Ability to
understand/explain various types of clinical
trials (i.e. randomized, double-blind,
double-dummy, open label, phaw I or II vs
III studies). |
Required |
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Working knowledge of FDA
regulations regarding clinical trials.
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Required |
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Experience with public
speaking and presentation. |
Required |
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Ability to collect and
analyze data to synthesize clinical events
for reporting purposes. |
Required |
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Ability to work
independently, as well as part of team.
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Required |
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Excellent interpersonal
skills (written and verbal). |
Required |
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Ability to assist in the
development and writing of grant
applications. |
Required |
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Previous experience with
computerized data entry and retrieval.
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Required |
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