The Cancer Clinical Trials Office (CCTO) is an
integral component of the Stanford Cancer Institute since it enables the
objective of our cancer center, to translate research from the laboratory into
the clinical setting. The OnCore Specialist will be a Cancer Clinical Trials
Office's expert on the oncology clinical research database application called OnCore Enterprise
used throughout the Cancer Institute and School of Medicine to manage
prospective clinical research studies.
Stanford University is seeking an OnCore
Application Specialist to capture and map
business requirements, and work with business partners to understand directions
and priorities to assure the delivery of information technology solutions. This position will
focus on support for oncological clinical research, supporting the production
system and ongoing maintenance, while maintaining close collaborations internal
to Stanford with Spectrum and IRT, and working with the vendor as needed. The
OnCore Specialist will be part of a team responsible for the collection and
quality assurance of NCI required data from Principal Investigators and
research staff, develop and deploy Stanford user-oriented documentation and
training sessions, provide ongoing support to users throughout the Cancer
Institute and School of Medicine, perform protocol and subject data entry into
OnCore, collaborate on, implement and roll-out new OnCore features and
functionality, develop and follow set standards for how data is entered into
the OnCore database, develop study calendars and electronic Case Report Forms
(eCRFs) in OnCore based upon protocol specifications for Investigator-initiated
trials, analyze clinical data from the eCRFs and generate tables for use in
presentations publications and posters, and prepare customized reports about
Stanford clinical trials and their accrual for the NCI, Cancer Center Administration,
and Principal Investigators. They will
continue to learn the system and expand their knowledge as new functionality is
introduced.
Duties include:
Diagnose and resolve end-user problems; respond to
escalated issues from clients and other support teams; perform triage,
provide remote problem resolution when possible, refer problems to
associated groups.
Analyze and document user needs, existing and new
policies, processes, procedures and operational methods to consider
possible improvements to new and existing systems.
Utilize elicitation techniques to understand business
processes and translate into system requirements and/or development of
systems solutions.
Define and document business requirements and test
cases for system developments. May include the writing of all or a portion
of functional specifications.
Coordinate with business and technology teams,
ascertaining system requirements, such as program functions, output
requirements, input data acquisition, and system techniques and
controls.
Perform testing of new systems, upgrades and patching
of existing systems; may include developing test plans. Conduct and
document results of testing.
Develop instructional materials, training and job aids.
Develop data collection tools for clinical research
studies. Develop and document data
collection standards.
Provide supervision and workload prioritization to
OnCore & Reporting team.
Coordinate the implementation of new
or modified business systems.
Prepare
customized reports about Stanford clinical trials and their accrual for
the NCI, Cancer Center Administration, and Principal Investigators
* - Other duties may also be assigned
DESIRED
QUALIFICATIONS:
Working knowledge of clinical trial design, FDA
regulations, IRB process and requirements and good clinical practice.
Experience working with the OnCore system from
Forte Research Systems desired.
Experience with SQL development tools (such as
SQL Developer); experience with report writing tools (such as iReport,
JasperReports) is desirable.
Demonstrated
excellent customer service skills
EDUCATION
& EXPERIENCE (REQUIRED):
Bachelor's degree and three years relevant
experience or a combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Knowledge of computer system capabilities, business
processes and work flow.
Understanding of the software development life cycle.
Experience with enterprise applications and
understanding of database driven applications.
Skill in conducting interviews.
Excellent communication skills, both written and
verbal, including the ability to bridge functional and technical resources
by communicating effectively with individuals of varying systems expertise
and business needs.
Listening, negotiation and conflict resolution skills.
Ability to maintain good customer relations with
clients and external vendors and partners.
PHYSICAL REQUIREMENTS*:
Constantly perform desk-based
computer tasks.
Frequently sit, grasp
lightly/fine manipulation.
Occasionally stand/walk, use a
telephone.
Rarely writing by hand,
lift/carry/push/pull objects that weigh up to 10 pounds.
* -
Consistent with its obligations under the law, the University will provide
reasonable accommodation to any employee with a disability who requires
accommodation to perform the essential functions of his or her job.
WORKING
CONDITIONS:
Work extended
hours.
WORK STANDARDS:
Interpersonal Skills: Demonstrates
the ability to work well with Stanford colleagues and clients and with external
organizations.
Promote Culture of Safety:
Demonstrates commitment to personal responsibility and value for safety;
communicates safety concerns; uses and promotes safe behaviors based on
training and lessons learned.
Subject to and expected to comply
with all applicable University policies and procedures, including but not
limited to the personnel policies and other policies found in the University's
Administrative Guide, http://adminguide.stanford.edu.
