Clinical Research Coordinator 2
Company: Stanford Medicine
Posted on: January 13, 2022
Pay Grade: H
Stanford University 'Maternal & Child Health Research Institute',
on behalf of the Department of Pediatrics, Division of
Gastroenterology, Hepatology, and Nutrition, is seeking a Senior
Clinical Research Coordinator (CRC2) to conduct clinical research
and work independently on complex projects/assignments in the area
of Pediatric Inflammatory Bowel Disease (IBD) and Celiac
The selected candidate must have the ability to implement, organize
and conduct all aspects of clinical studies combined with knowledge
of good clinical practice (GCP) and health care economics including
insurance billing, research-related financial and budgetary
processes (tracking study costs and sponsor payments). S/he will
support patients participating in research studies and medical
faculty in all aspects of clinical and translational research
studies including regulatory compliance, study implementation,
protocol development, data management, teaching and training of
clinical staff, and maintaining research databases that are used to
promote high quality care and improve performance in the clinical
care of patients. Previous clinical research experience is
required. Previous clinical trial experience at Stanford and/or
LPCH is highly desirable.
The selected candidate will work within the Pediatric IBD and
Celiac Disease Program, which is supported by a transformative
philanthropic gift. Clinical research within the program will
include patient biobanking and data collection concurrent with
clinical care, local investigator-initiative study, and multicenter
investigator-initiated studies and industry-sponsored clinical
The Pediatric GI Division has approximately 30 pediatric
gastroenterologists with nationally recognized expertise through
their research, teaching, and clinical programs which attracts
leading candidates to their fellowship program. We have a mission
of healing children with digestive disease through innovation. Our
Pediatric GI Specialty provide comprehensive GI care to children
throughout our region. We lead global destination programs that
deliver highly specialized care and train the next generation of
pediatric gastroenterologists, and inspire hope through innovation.
Our high quality, collaborative care is driven by cutting-edge
research and active partnerships between doctors, nurses, and staff
throughout the Stanford Children's Health network, scientists at
Stanford University, and patient families. Together, we are
changing the lives of children today and shaping care for
The Department of Pediatrics is a dynamic, stimulating place to
work and because we are focused on growth and improved excellence,
our staff have particularly challenging and rewarding roles.
- 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.
* - Other duties may also be assigned
- A bachelor's degree in the biological sciences, medicine or
public health is highly desired.
- Excellent oral and written communication skills
- Experience with managing clinical data in a research
- Proficiency in using computers, software, and web-based
applications in a previous administrative setting
- Experience training , mentoring, and/or supervising others on
topics related to clinical research conduct and management
- Proficiency in Spanish (verbal and written) desired.
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 with Microsoft Office and database
- 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.
Additional trainings and competencies obtained through continuing
education, training coursework, webinars, etc. in any area of
performing clinical research is strongly preferred.
- 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.
- Position may at times require the employee to work with or be
in areas where hazardous materials and/or exposure to chemicals,
blood, body fluid or tissues and risk of exposure to contagious
disease and infections.
- Position may at times require being on-call and/or require
working during weekend, extended or unusual work hours based on
research requirements and business needs.
- Position will be required to support studies that are conducted
at off-site clinics (within a 20-mile radius of the main campus).
Incumbent will need to provide own transportation with the ability
to get to/from these off-site clinics
Position will require air flight travels to certain destinations
(domestic and international, as needed) in order to participate in
research-related events such as Investigator Meetings
- Schedule: Full-time
- Job Code: 4923
- Employee Status: Regular
- Pay Grade: H
- Department URL: http://pediatrics.stanford.edu/
- Requisition ID: 91667 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, Oakland , Clinical Research Coordinator 2, Healthcare , Oakland, California
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