Sr. ICU Clinical Research Coordinator
Company: Stanford Medicine
Location: San Leandro
Posted on: January 13, 2022
The Division of Pulmonary, Allergy and Critical Care Medicine
(PACCM) is comprised of a team of outstanding clinicians,
scientists, and scholars dedicated to improving the lives of
patients with serious lung disease. Our goal is to provide
outstanding clinical and research training to the next generation
of leaders in Pulmonary and Critical Care Medicine. We are
committed to strong clinical investigations including the
evaluation of new pharmacologic agents, which offer potentially
promising therapeutic benefits, as well as outcome studies which
characterize clinical parameters to effect positive changes in
PACCM is seeking a Sr. ICU Clinical Research Coordinator (Clinical
Research Coordinator 2) to conduct clinical research and work
independently on progressively more complex projects/assignments.
Independently manage significant and key aspects of a large study
or all aspects of one or more small research studies.
- 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
- Knowledge of data analysis in R or Python is a plus and would
enable greater input into data analysis but not required.
- Advanced medical knowledge is a major plus, and interest in
learning with PI MD team in depth about inpatient ICU medicine is
required to enable optimal enrollment of patients across numerous
- Skilled in communication with patients, families, and health
- Knowledge of International Conference on Harmonization (ICH)
- Advanced certification such as a CCRA or CCRC, certification
from a Clinical Research Training Program or equivalent or
willingness to pursue this certification in first 6 months on the
- Leadership experience is a plus, as this position will have
several direct reports within Stanford, and lead
multi-institutional meetings with other sites.
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.
- 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.
- 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
diseases and infections.
- May require extended or unusual work hours based on research
requirements and business needs.
- 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 law.
- Schedule: Full-time
- Job Code: 4923
- Employee Status: Regular
- Pay Grade: H
- Requisition ID: 89611 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 , Sr. ICU Clinical Research Coordinator, Healthcare , San Leandro, California
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