Clinical Research Operations Specialist II - Multisite
Company: Stanford University
Location: San Bruno
Posted on: May 24, 2023
The mission of is to conduct high-impact, innovative clinical
research to improve human health. SCCR is an Academic Research
Organization within the Stanford Department of Medicine. SCCR
leverages the physical and intellectual resources of Stanford
University and its affiliated teaching hospitals and research
centers to achieve its mission.The Stanford Center for Clinical
Research (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 oncology and 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 a key point of contact for the study sponsor, sites, vendors,
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.SCCR aims to find team members
who are passionate about their work, are flexible, innovative, and
want to deliver results. We place a high priority on equipping our
team members to perform their job efficiently, helping them acquire
new skills and grow within the organization. If you are looking to
make a large impact through global-reaching clinical research in a
rapidly growing academic research organization, we encourage you to
- Oversee subject recruitment and study enrollment goals.
Determine effective strategies for promoting/recruiting research
participants and retaining participants in long-term clinical
- 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
- 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
- Collaborate with principal investigators and study sponsors,
monitor and report serious adverse events, and resolve study
- Provide leadership in determining, recommending, and
implementing improvements to policies/processes; define best
- 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
- 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
- Review Board initial submissions are made and renewals are
completed.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. DESIRED QUALIFICATIONS:
- Bachelor's degree in Clinical Research/Public Health/ Business
or related field.
- 2 years experience in project management and clinical research
- Excellent communication skills.
- Excellent speaking and writing skills.
- Demonstrated ability to write manuals and procedural
- Demonstrated ability to give presentations to
- 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
- 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
- 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 or
Stanford's CROP certification is preferred.May require a valid
California Driver's License.
- Frequently stand, walk, twist, bend, stoop, squat and use fine
- 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.
- Interpersonal Skills: Demonstrates the ability to work well
with Stanford colleagues and clients and with external
- 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
- 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 Pay Structures. The
compensation for this position will be based on the location of the
successful candidate.The expected pay range for this position is
$61,000 to $93,000 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.
Why Stanford is for youImagine 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,
- Enviable resources. Enjoy free commuter programs, ridesharing
incentives, discounts and more.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 Bruno , Clinical Research Operations Specialist II - Multisite, Accounting, Auditing , San Bruno, California
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