Clinical Research Coordinator-II, TreatCOVID
Company: Stanford University
Location: San Mateo
Posted on: January 27, 2023
Job Description:
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 & ChEM-H, SCCR is seeking a Clinical Research
Coordinator-II (CRC-II) to perform duties related to the
coordination of clinical research studies, including long
COVID.
The CRC-II 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
CRC-II will 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 candidate. 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 to apply!
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. - 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.
DESIRED QUALIFICATIONS:
- Clinical research operations certification from SOCRA, ACRP or
Stanford's CROP.
- Spanish fluency. 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. 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. - 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.
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 University's
Administrative Guide, . 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,
and museums.
- 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.
Keywords: Stanford University, San Mateo , Clinical Research Coordinator-II, TreatCOVID, Healthcare , San Mateo, California
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