Clinical Research Operations Specialist II
Company: Stanford University
Location: Stanford
Posted on: November 6, 2024
Job Description:
(SCCR) is a growing academic research organization within the
Stanford Department of Medicine. Our mission is to conduct and
promote high-impact, innovative clinical research to improve human
health.SCCR is seeking a Clinical Research Operations Specialist II
to conduct and manage multi-site clinical trials. Research will be
conducted in a variety of therapeutic areas, including
cardiovascular medicine. The Clinical Research Operations
Specialist II will be responsible for the management of virtual and
multisite operations by ensuring adequate study start up,
regulatory submissions and training of each of the study sites in
preparation for site activation. This position will be the main
point of contact for the study sponsor and the study PI. This
position will assist in the management of the entire study from
startup to closeout and will ensure adherence to regulatory
requirements.In addition to the core duties described below, this
position will be responsible for the following: a) leading efforts
in collection of participant safety data; b) drafting and reviewing
study Operations Manuals and Documents; and c) tracking study
issues.At SCCR, we strive to find team members who are passionate
about their work, flexible, fun, and want to deliver results. We
place a high priority on equipping our staff to perform their job
efficiently, helping them acquire new skills and grow within the
organization. We encourage our team to have a healthy balance
between work commitments and life outside of work and provide
support to achieve this balance. If you are looking to make a large
impact through global-reaching clinical research, we encourage you
to apply!Duties 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. DESIRED QUALIFICATIONS:
Clinical research certification from
ACRP, SOCRA, or Stanford's CROP.Bachelor's degree in Clinical
Research/Public Health/ Business or related field.2 years
experience in project management and clinical research
projects.Excellent communication skills.Excellent speaking and
writing skills.Demonstrated ability to write manuals and procedural
documents.Demonstrated ability to give presentations to
stakeholders.Knowledge of Clinical Research Study Startup processes
including IRB submissions, site feasibility analyses.Experience
developing budgets.Experience supervising, training, and/or
mentoring new staff or students.Strong leadership skills necessary
for determining, recommending, and implementing improvements to
policies/processes and best practices.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 in 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.WORKING
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, .This role
is open to candidates anywhere in the United States. Stanford
University has five . The compensation for this position will be
based on the location of the successful candidate. The expected pay
range for this position is $59,000 to $82,000 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. 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.Why Stanford is
for You
Imagine a world without search engines or social platforms.
Consider lives saved through first-ever organ transplants and
research to cure illnesses. Stanford University has revolutionized
the way we live and enrich the world. Supporting this mission is
our diverse and dedicated 17,000 staff. We seek talent driven to
impact the future of our legacy. Our culture and empower you with:
Freedom to grow. We offer career
development programs, tuition reimbursement, or audit a course.
Join a TedTalk, film screening, or listen to a renowned author or
global leader speak.A caring culture. We provide superb retirement
plans, generous time-off, and family care resources.A healthier
you. Climb our rock wall, or choose from hundreds of health or
fitness classes at our world-class exercise facilities. We also
provide excellent health care benefits.Discovery and fun. Stroll
through historic sculptures, trails, and museums. Enviable
resources. Enjoy free commuter programs, ridesharing incentives,
discounts and more.The job duties listed are typical examples of
work performed by positions in this job classification and are not
designed to contain or be interpreted as a comprehensive inventory
of all duties, tasks, and responsibilities. Specific duties and
responsibilities may vary depending on department or program needs
without changing the general nature and scope of the job or level
of responsibility. Employees may also perform other duties as
assigned.Consistent with its obligations under the law, the
University will provide reasonable accommodations to applicants and
employees with disabilities. Applicants requiring a reasonable
accommodation for any part of the application or hiring process
should contact Stanford University Human Resources at
stanfordelr@stanford.edu. For all other inquiries, please submit a
.Stanford is an equal employment opportunity and affirmative action
employer. All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, sexual
orientation, gender identity, national origin, disability,
protected veteran status, or any other characteristic protected by
law.
Keywords: Stanford University, San Jose , Clinical Research Operations Specialist II, Healthcare , Stanford, California
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