Cancer Lead Clinical Research Coordinator 2 - Early Drug Development
Company: Stanford University
Location: Stanford
Posted on: September 19, 2023
Job Description:
The Stanford Cancer Institute (SCI) is one of an elite number of
National Cancer Institute-Designated Comprehensive Cancer Centers
in the country, and is a prominent, dynamic, growing, and complex
Institute within the Stanford University School of Medicine. The
SCI actively works to build synergies and collaborations among
faculty with cancer-relevant expertise from four Schools and over
30 departments across Stanford University. We seek a Cancer Lead
Clinical Research Coordinator 2 - Early Drug Development to help us
enact our mission to reduce cancer mortality through comprehensive
programs of cancer research, treatment, education, and outreach.
Given the SCI's mission, breadth, and depth, it employs over 320
staff members in a fast-paced, team-oriented, and forward-thinking
environment with tremendous opportunities for personal and
professional growth. The Cancer Clinical Trials Office (CCTO) is an
integral component of the Stanford Cancer Institute. The vital work
performed there enables our adult and pediatric cancer centers to
translate research from the laboratory into the clinical setting.
You will be working with an unparalleled leading-edge community of
faculty and staff who are fundamentally changing the world of
health care in the cancer arena.
Reporting to the Early Drug Development Clinical Research Manager,
the Cancer Lead Clinical Research Coordinator 2 will be conversant
in the goals, mission, and priorities of the Institute and utilize
this knowledge to support the clinical trials and program. We seek
candidates with excellent organization, teamwork, communication,
and writing skills. Our staff runs toward challenges, and you will
have a demonstrated history of doing the same with a high degree of
professionalism, initiative, and flexibility. Responsibilities
include:
Oversee subject recruitment and study
enrollment goals. Determine effective strategies for
promoting/recruiting research participants and retaining
participants in long-term clinical trials.Oversee data management
for research projects. Develop and manage systems to organize,
collect, report, and monitor data collection. Extract, analyze, and
interpret data.Develop project schedules, targets, measurements,
and accountabilities, as assigned. Lead team meetings and
prepare/approve minutes.Formally supervise, train, and/or mentor
new staff or students, as assigned, potentially including hiring,
preparing or assisting with the preparation of performance
evaluations, and performing related duties, in addition to
instruction on project work. Audit operations, including laboratory
procedures, to ensure compliance with applicable regulations;
provide leadership in identifying and implementing corrective
actions/processes. Monitor Institutional Review Board submissions,
and respond to requests and questions.Collaborate with principal
investigators and study sponsors, monitor and report serious
adverse events, and resolve study queries.Provide leadership in
determining, recommending, and implementing improvements to
policies/processes; define best practices.Develop study budget with
staff and principal investigator, identifying standard of care
versus study procedures. Track patient and study specific
milestones, and invoice sponsors according to study contract.Ensure
regulatory compliance. Regularly inspect study document to ensure
ongoing regulatory compliance.Work with principal investigator to
ensure Investigational New Drug applications are submitted to the
FDA when applicable. Ensure Institutional Review Board renewals are
completed.* - Other duties may also be assigned. DESIRED
QUALIFICATIONS:
Previous oncology experience.Previous
experience as a Clinical Research Coordinator 2.EDUCATION &
EXPERIENCE (REQUIRED):Bachelor's degree in a related field and two
years of experience in clinical research, or an equivalent
combination of education and relevant experience.KNOWLEDGE, SKILLS
AND ABILITIES (REQUIRED):
Strong interpersonal
skills.Proficiency with Microsoft Office and database
applications.Experience with research protocols and regulatory or
governing bodies, which include HIPAA and FDA regulations,
Institutional Review Board requirements, and Good Clinical
Practices.Knowledge of medical terminology.CERTIFICATIONS &
LICENSES:Society of Clinical Research Associates or Association of
Clinical Research Professionals certification is preferred. May
require a valid California Driver's License.PHYSICAL REQUIREMENTS*:
Frequently stand, walk, twist, bend,
stoop, squat and use fine light/fine grasping. Occasionally sit,
reach above shoulders, perform desk based computer tasks, use a
telephone and write by hand, lift, carry, push, and pull objects
that weigh up to 40 pounds.Rarely kneel, crawl, climb ladders,
grasp forcefully, sort and file paperwork or parts, rarely lift,
carry, push, and pull objects that weigh 40 pounds or more.* -
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:
Position may at times require the
employee to work with or be in areas where hazardous materials
and/or exposure to chemicals, blood, body fluid or tissues and risk
of exposure to contagious diseases and infections.May require
extended or unusual work hours based on research requirements and
business needs.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, .The
expected pay range for this position is $72,000 to $92,000 per
annum. Stanford University provides pay ranges representing its
good faith estimate of what the university reasonably expects to
pay for a position. The pay offered to a selected candidate will be
determined based on factors such as (but not limited to) the scope
and responsibilities of the position, the qualifications of the
selected candidate, departmental budget availability, internal
equity, geographic location and external market pay for comparable
jobs.At Stanford University, base pay represents only one aspect of
the comprehensive rewards package. The Cardinal at Work website ()
provides detailed information on Stanford's extensive range of
benefits and rewards offered to employees. Specifics about the
rewards package for this position may be discussed during the
hiring process
Keywords: Stanford University, San Francisco , Cancer Lead Clinical Research Coordinator 2 - Early Drug Development, Other , Stanford, California
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