Clinical Research Supervisor
Company: Stanford Medicine
Location: Dublin
Posted on: June 26, 2022
Job Description:
The Divisions of Pediatric Critical Care Medicine is seeking a
Clinical Research Coordinator 2 to conduct clinical research and
work independently on progressively more complex
projects/assignments. The Clinical Research Coordinator 2 will
independently manage significant and key aspects of a large study
or all aspects of one or more small research studies.
This is an onsite role requiring you to be on campus in Palo Alto,
CA.
We are a growing team including long-tenured faculty, staff, and
leadership. The Division activities reach all parts of the mission:
patient care, education, and research. The Clinical Research
Coordinator 2 will have a great deal of exposure to all these areas
and will be communicating with a broad range of individuals at the
Executive level, internally and externally. Within the Divisions
and Center, there is a strong operations team of about 15 people.
We are a supportive group that prioritizes well-being, with many
team events and opportunities for professional development and
personal growth. We value balancing home and work life. We foster
an environment that leads to fulfilling and rewarding careers at
Stanford University for all staff. Please check out our website and
social media channels below, and come see about working for an
organization that directly impacts the lives of children.
https://med.stanford.edu/pedcriticalcare.html
https://twitter.com/stanfordpccm
Duties include:
- Serve as primary contact with research participants, sponsors,
and regulatory agencies. Coordinate studies from startup through
close-out.
- Determine eligibility of and gather consent from study
participants according to protocol. Assist in developing
recruitment strategies.
- Coordinate collection of study specimens and processing-- some
protocols may require the CRC to collect and process the research
samples.
- Collect and manage patient and laboratory data for clinical
research projects. Manage research project databases, develop flow
sheets and other study related documents, and complete study
documents/ case report forms.
- Ensure compliance with research protocols, and review and audit
case report forms for completion and accuracy with source
documents. Prepare regulatory submissions and ensure institutional
Review Board renewals are completed.
- Assemble study kits for study visits, monitor scheduling of
procedures and charges, coordinate documents, and attend monitoring
meetings with sponsors, acting as primary contact.
- Monitor expenditures and adherence to study budgets and resolve
billing issues in collaboration with finance and/or management
staff.
- Interact with the principal investigator regularly, ensuring
patient safety and adherence to proper study conduct.
- Ensure essential documentation and recording of patient and
research data in appropriate files per institutional and regulatory
requirements.
- Participate in monitor visits and regulatory audits.
* - Other duties may also be assigned
DESIRED QUALIFICATIONS:
- Spanish speaking
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
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.
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 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.
Additional Information
- Schedule: Full-time
- Job Code: 4923
- Employee Status: Regular
- Pay Grade: H
- Department URL: http://pediatrics.stanford.edu/
- Requisition ID: 94774 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
https://cardinalatwork.stanford.edu/working-stanford/covid-19/interim-policies/covid-19-surveillance-testing-policy
Keywords: Stanford Medicine, Dublin , Clinical Research Supervisor, Accounting, Auditing , Dublin, California
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