To be successful in this role, you will bring:
- Bachelor’s degree in related field and five years of
experience in clinical research, or an equivalent combination of education
and relevant experience. Master's degree preferred.
- Excellent 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.
- Demonstrated managerial experience.
In addition, preferred
requirements include:
- Five years of clinical research experience in an
academic health center, pharmaceutical, biotechnology, or CRO industry or
equivalent.
- Three years of experience as a research manager or
equivalent formal supervision duties.
- Clinical Research Certificate (ACRP, SOCRA, CROP).
- Ensures work is done on time in a high-quality manner.
- Knowledge of clinical pharmacology and pathophysiology,
and food allergy research.
- Demonstrated excellence in complex project management
and effectively managing multiple projects/priorities
- Experience managing cross-functional teams or work
groups as well as direct reports.
- Demonstrated understanding of pharmaceutical regulatory
requirements and impact on development of clinical trials.
- Strong regulatory knowledge and ability to perform
monitoring of CRFs, GCP and GMP. This position must know IRB regulations
and how to perform IRB submissions. Working knowledge of FDA procedures as
applicable, and ICH-GCP and relevant SOPs.
- Disciplined work approach with the ability to function
independently, take initiative and effectively problems solve issues.
- Customer service oriented both internally and
externally with strong organizational, interpersonal and communication
skills.
- Society of Clinical Research Associates or Association
of Clinical Research Professionals certification.
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, 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, 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.