Clinical Research Operations Specialist 2 (RECOVER)
Company: Stanford Medicine
Posted on: June 21, 2022
The Stanford Center for Clinical Research (SCCR) is a growing
academic research organization within the Stanford Department of
Medicine. Our mission is to advance impactful clinical research
through quality operations.
In collaboration with the Division of Infectious Diseases and the
Clinical & Translational Research Unit at Stanford, SCCR is seeking
a Clinical Research Operations Specialist 2 to perform duties
related to the coordination of a large, complex COVID study. This
exciting study involves multiple disciplines, including Infectious
Diseases, Innovative Medicines Accelerator initiative, Transplant
division, Hospital Medicine, Emergency Medicine, and others. This
is a central operations role for a large multisite study conducted
with six teams at Stanford, and this position may serve as a backup
to CRC-IIs when needed.
The Operations Specialist 2 will work closely with the PI and
Clinical Research Manager (CRM) in a dynamic environment, and be
responsible for supporting multiple staff members, including
coordinators. The Operations Specialist 2 will work on multiple
studies to develop recruitment and retention strategies, oversee
study operation and conduct, oversee regulatory compliance and
financial logistics, and ensure overall progress on the project.
The position will report project progress to the team and
trouble-shoot barriers. Outstanding communication and
organizational skills, the ability to proactively manage
challenges, a strong grounding/background in clinical research, and
attention to detail are qualities desired in a successful
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
- 2-4 years clinical research coordinator experience, preferably
with multisite projects.
- Clinical Research Certification, Society of Clinical Research
Associates, Association of Clinical Research Professionals
certification and Stanford CROP certification is preferred.
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.
- 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, http://adminguide.stanford.edu/ .
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
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,
- Schedule: Full-time
- Job Code: 4923
- Employee Status: Regular
- Pay Grade: H
- Requisition ID: 92184 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, please visit
Keywords: Stanford Medicine, Milpitas , Clinical Research Operations Specialist 2 (RECOVER), Healthcare , Milpitas, California
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