Clinical Research Operations Specialist I
Company: Stanford Medicine
Location: San Leandro
Posted on: January 10, 2022
The Stanford Center for Clinical Research (SCCR), in
collaboration with the Stanford Departments of Medicine,
Neurosurgery, Bioengineering and Radiology, is conducting large,
innovative longitudinal studies. SCCR is seeking to hire a Clinical
Research Operations Specialist I to support duties related to the
coordination of clinical studies. Coordinate moderately complex
aspects of one or more clinical studies. Work under close direction
of the principal investigator and/or study Operations Manager.
SCCR provides infrastructure and research support to Stanford
clinical research investigators. Its mission is to conduct and
promote high-impact, innovative clinical research to improve human
The Clinical Research Operations Specialist I will work within a
multidisciplinary team, including physicians, athletic trainers,
and coaches; and have direct interaction with participants. The
Clinical Research Operations Specialist I is required to have the
ability to multi-task in a high-energy environment. This position
may involve traveling to study sites and being able to attend the
athletic games and practice sessions. The Clinical Research
Operations Specialist I is required to have flexibility in their
work schedule and outstanding communication and organizational
skills with attention to detail. The study visits may occur in the
evenings and occasionally during weekends. The Clinical Research
Operations Specialist I will be responsible for ensuring compliance
with federal, state, local, and sponsor regulations and work under
the direction of their supervisor.
- Serve as primary contact with research participants, sponsors,
and regulatory agencies. Coordinate studies from start-up through
- Determine eligibility of and gather consent from study
participants according to protocol. Assist in developing
- Collect and manage patient and laboratory data for clinical
research projects. Manage research project databases, develop flow
sheets and other study related documents, and complete study
documents/case report forms.
- Ensure compliance with research protocols, and review and audit
case report forms for completion and accuracy with source
documents. Prepare regulatory submissions, and ensure Institutional
Review Board renewals are completed.
- Assemble study kits for study visits, monitor scheduling of
procedures and charges, coordinate documents, and attend monitoring
meetings with sponsors, acting as primary contact.
- Monitor expenditures and adherence to study budgets and resolve
billing issues in collaboration with finance and/or management
- Interact with the principal investigator regularly, ensuring
patient safety and adherence to proper study conduct.
- Ensure essential documentation and recording of patient and
research data in appropriate files per institutional and regulatory
- Participate in monitor visits and regulatory audits.
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
EDUCATION & EXPERIENCE (REQUIRED):
- Two-year college degree and two years related work experience
or a Bachelor's degree in a related field or an equivalent
combination of related education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Strong interpersonal skills.
- Proficiency with Microsoft Office.
- Knowledge of medical terminology.
CERTIFICATIONS & LICENSES:
- Society of Clinical Research Associates or Association of
Clinical Research Professionals certification is preferred.
- Working toward certification(s) to perform basic patient
measurements and tests, such as phlebotomy and EKG.
- Occasional evening and weekend hours.
- 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: 4924
- Employee Status: Regular
- Pay Grade: F
- Requisition ID: 92544 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, San Leandro , Clinical Research Operations Specialist I, Healthcare , San Leandro, California
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