Senior Clinical Research Coordinator (Multiple Openings)
Company: Stanford University
Posted on: November 18, 2023
Stanford University, School of Medicine is seeking several
Senior Clinical Research Coordinators 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
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
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 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
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
EDUCATION & EXPERIENCE:
Bachelor's degree in a related field and two years of experience in
clinical research, or an equivalent combination of education and
KNOWLEDGE, SKILLS AND ABILITIES:
Strong interpersonal skills
Proficiency with 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.
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
diseases and infections.
May require extended or unusual work hours based on research
requirements and business needs.
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 vist this link.
Keywords: Stanford University, San Francisco , Senior Clinical Research Coordinator (Multiple Openings), Healthcare , Stanford, California
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