Clinical Research Operations Specialist II
Company: Stanford University
Location: San Mateo
Posted on: January 19, 2023
The Stanford Center for Clinical Research (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
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.
This may be a hybrid position.
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
- 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
Institutional Review Board 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.
- Clinical research certification from ACRP, SOCRA, or Stanford's
- 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 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
- Strong leadership skills necessary for determining,
recommending, and implementing improvements to policies/processes
and best practicesEDUCATION & 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 certification is preferred. May
require a valid California Driver's License.PHYSICAL REQUIREMENTS:
- 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, .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 unique perks
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.
As an organization that receives federal funding, Stanford
University has a COVID-19 vaccination requirement that will apply
to all university employees, including those working remotely in
the United States and applicable subcontractors. To learn more
about COVID policies and guidelines for Stanford University Staff,
Keywords: Stanford University, San Mateo , Clinical Research Operations Specialist II, Healthcare , San Mateo, California
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