Clinical Research Manager
Company: Stanford University
Posted on: November 18, 2023
The Department of Dermatology (Dermatology Operations) within
Stanford University, is a dynamic and innovative Department
dedicated to excellence in research, medical education, and
clinical care. Our Department is driven by over 70 faculty members
and a cadre of staff who are the pillar of strength in the
Department's ongoing efforts into the prevention and treatment of
various dermatologic diseases, conditions & disorders.
We are seeking a Clinical Research Manager (CRM) who is passionate
about clinical research and project management. The CRM will report
to the Associate Director, Clinical Research Operations and work
with a robust clinical research team, hand in hand with Principal
Investigators, Clinical Research Managers, Program Managers, and
Associates in support of dermatology patients. The Clinical
Research Manager will provide leadership and oversight of studies
conducted by several affinity groups within the Department. The
Clinical Research Manager will manage clinical research operations,
relationships with other affinity groups and staff, study quality
management, personnel management and career skill development,
regulatory compliance, and fiscal oversight. The CRM will also
assist with building automated clinical research workflows and
solutions within the Department. The successful applicant will have
the ability to supervise multiple clinical research staff,
collaborate with external vendors, and enjoy working in a dynamic
work environment. Exceptional diplomacy, interpersonal and
communication skills are essential, as is a high degree of
integrity. Attention to detail and the ability to manage multiple
responsibilities simultaneously are also critical attributes.
Our Department strives to find team members who are passionate
about their work, are creative and want to deliver results. We
place a high priority on equipping our team members to perform
their job efficiently, helping them acquire new skills and grow
within the organization. We encourage our team members 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 in a
rapidly growing academic research organization, we encourage you to
Note the position will be based on the Stanford Redwood City (SRWC)
campus and is hybrid (working on-site and working from home)
subject to operational needs.
Dermatology Clinical Research is a growing team that's dedicated to
supporting translational medicine and contributing to Stanford
Medicine's mission. We invite you to join our team!
Hire, orient, train, and conduct performance reviews for staff
handling research administration activities associated with the
conducting of clinical trials. Monitor staffing levels and identify
adequate coverage for trial workload across teams of study
Supervise the implementation of and adherence to study protocols.
Educate research staff on established policies, processes, and
Determine effective strategies for promoting/recruiting research
participants and retaining participants in long-term clinical
trials. Develop consent forms for approval by Human Subjects
Coordinate new protocol submissions, renewals, and revisions to
Institutional Review Board for multiple studies. Complete annual
reports to Institutional Review Board, CSTA, FDA and other
regulatory agencies. Submit Investigational New Drug applications
to the FDA as required.
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
Provide leadership and expertise in identifying and completing
research grants. Oversee financial resources, as needed, create
internal and external budgets for research protocols, assure
financial accountability, and serve as primary liaison between
sponsor, department accounting, and Research Management Group.
Lead or chair committees or task forces to address and resolve
Engage in high-level outreach and networking opportunities,
representing the research program to a variety of internal and
Analyze trends in recruitment and assure there is a limited number
of competing trials. Make recommendations for a variety of options
within a trial; track physician compliance.
Assist with analysis of data and preparation of manuscripts and
* - Other duties may also be assigned
Experience developing reports and dashboards.
Experience with Smartsheet.
Experience with Notion.
EDUCATION & EXPERIENCE (REQUIRED):
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.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
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.
CERTIFICATIONS & LICENSES:
Society of Clinical Research Associates or Association of Clinical
Research Professionals certification is preferred.
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.
The expected pay range for this position is $108,000 to $136,000
per annum/hour. Stanford University provides pay ranges
representing its good faith estimate of what the university
reasonably expects to pay for a position. The pay offered to a
selected candidate will be determined based on factors such as (but
not limited to) the scope and responsibilities of the position, the
qualifications of the selected candidate, departmental budget
availability, internal equity, geographic location and external
market pay for comparable jobs.
At Stanford University, base pay represents only one aspect of the
comprehensive rewards package. The Cardinal at Work website
detailed information on Stanford's extensive range of benefits and
rewards offered to employees. Specifics about the rewards package
for this position may be discussed during the hiring process.
Keywords: Stanford University, San Francisco , Clinical Research Manager, Healthcare , Stanford, California
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