Senior Clinical Research Coordinator and Regulatory Lead
Company: Stanford Medicine
Posted on: May 15, 2022
Stanford University is seeking a Clinical Research Coordinator 2
(CRC) to join Dr. Franc and the Radiology Department within School
Dr. Franc predominantly publishes and lectures on applications and
innovations of PET-CT. He has proficiency in all aspects of PET
radiopharmaceutical development, spanning the design of molecules,
synthesis of radioligands, and use in animal and human imaging. He
also has expertise in quantitative image analysis, development of
novel post-processing image reconstruction methods, and the
application of artificial intelligence in human diagnostics. Dr.
Franc has implemented new radiopharmaceuticals in pre-clinical and
clinical research PET imaging as well as for clinical PET with
applications in cancer, infectious disease (HIV), and autoimmune
In the CRC role, you will conduct clinical research and work
independently on progressively more complex projects/assignments.
Including but not limited to managing significant and key aspects
of a large study or all aspects of one or more small research
This position is based on Stanford University's School of Medicine
campus with a hybrid work schedule (partially onsite and offsite),
subject to operational need. Interested candidates should include a
resume and cover letter.
- 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.
* - Other duties may also be assigned.
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.
* - 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.
- 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 .
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,
- Schedule: Full-time
- Job Code: 4923
- Employee Status: Regular
- Pay Grade: H
- Department URL: http://radiology.stanford.edu/
- Requisition ID: 92689 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, Berkeley , Senior Clinical Research Coordinator and Regulatory Lead, Healthcare , Berkeley, California
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