Clinical Research Coordinator 2 (Gastro Studies)
Company: Stanford University
Location: Stanford
Posted on: October 12, 2024
Job Description:
The Division of Gastroenterology and Hepatology has a long
tradition of major contributions in basic research, a new
commitment to clinical and outcomes research, a track record of
training fellows for academic careers, and a longitudinal
commitment to providing care for patients with complex
gastrointestinal and liver diseases.The Kwo Lab is seeking a
Clinical Research Coordinator II (CRC2) to provide support for
clinical research efforts in the Division of Gastroenterology and
Hepatology. In this role, the CRC2 will independently conduct 4-6
new gastroenterology complex clinical drug studies to test novel
therapies in chronic liver disease, including the MERCK IBD Study.
Responsibilities will also include overseeing
investigator-initiated studies. These studies will focus on testing
novel therapies in human subjects to treat viral liver disease,
metabolic dysfunction associated with steatotic liver disease,
alcohol-associated liver disease, and cirrhosis, and will include
Phase 1, Phase 2, and Phase 3 studies. The CRC2 will independently
manage the studies from start-up through close-out and conduct FDA
audits if applicable.Duties include:
- Oversee subject recruitment and study enrollment goals.
Determine effective strategies for promoting/recruiting research
participants and retaining participants in long-term clinical
trials.
- 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
prepare/approve minutes.
- 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
questions.
- Collaborate with principal investigators and study sponsors,
monitor and report serious adverse events, and resolve study
queries.
- Provide leadership in determining, recommending, and
implementing improvements to policies/processes; define best
practices.
- 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
study contract.
- 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. DESIRED
QUALIFICATIONS:Strong organizational skills.EDUCATION & EXPERIENCE
(REQUIRED):Bachelors 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 Drivers License.PHYSICAL REQUIREMENTS:
- Frequently stand, walk, twist, bend, stoop, squat and use fine
light/fine grasping.
- 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.WORKING CONDITIONS:
- 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.
WORKING STANDARDS:
- Interpersonal Skills: Demonstrates the ability to work well
with Stanford colleagues and clients and with external
organizations.
- 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
learned.
- 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 Universitys
Administrative Guide, style="font-family: Arial;"> The expected
pay range for this position is $84,856 to $97,021 per
annum.Stanford University provides pay ranges representing its good
faith estimate of what the university reasonably expects to pay for
a position. The pay offered to a selected candidate will be
determined based on factors such as (but not limited to) the scope
and responsibilities of the position, the qualifications of the
selected candidate, departmental budget availability, internal
equity, geographic location and external market pay for comparable
jobs.
At Stanford University, base pay represents only one aspect of the
comprehensive rewards package. The Cardinal at Work website
provides detailed information on Stanfords extensive range of
benefits and rewards offered to employees. Specifics about the
rewards package for this position may be discussed during the
hiring process.Why Stanford is for YouImagine 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,
and museums.
- Enviable resources. Enjoy free commuter programs, ridesharing
incentives, discounts and more.
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.Consistent with its obligations under the law, the
University will provide reasonable accommodations to applicants and
employees with disabilities. Applicants requiring a reasonable
accommodation for any part of the application or hiring process
should contact Stanford University Human Resources at . For all
other inquiries, please submit a contact form.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. Required
Keywords: Stanford University, Redwood City , Clinical Research Coordinator 2 (Gastro Studies), Healthcare , Stanford, California
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