Clinical Research Manager
Company: Stanford University
Location: San Leandro
Posted on: May 16, 2023
Job Description:
The (CV Med), within Stanford University Department of Medicine,
is a dynamic and innovative center dedicated to excellence in
research, medical education, and clinical care. Our Division is
driven by over 90 faculty members and a cadre of staff who are the
pillar of strength in the Division's ongoing efforts into the
prevention and treatment of cardiovascular disease.We are seeking a
Clinical Research Manager (CRM) who is passionate about clinical
research and project management. The CRM will report to the
Director of Clinical Research and work with a robust clinical
research team, hand in hand with Principal Investigators, Clinical
Research Managers, Nurse Managers, and Associates in support of
cardiac patients. The Clinical Research Manager will provide
leadership and oversight of studies conducted by several affinity
groups within the Division, including General Cardiology and the
Preventive Cardiology group. 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 Division.Note
the position will be based on the Stanford campus and is a hybrid
(working on-site and working from home) subject to operational
needs.CV Med Clinical Research is a growing, dynamic team who are
dedicated to supporting translational medicine and contributing to
Stanford Medicine's mission. We invite you to join our team!Duties
include:
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 coordinators.Supervise the
implementation of and adherence to study protocols. Educate
research staff on established policies, processes, and
procedures.Determine effective strategies for promoting/recruiting
research participants and retaining participants in long-term
clinical trials. Develop consent forms for approval by Human
Subjects Panel.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 questions.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 significant
issues.Engage in high-level outreach and networking opportunities,
representing the research program to a variety of internal and
external audiences.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.The
job duties listed are typical examples of work performed by
positions in this job classification and are not designed to
contain or be interpreted as a comprehensive inventory of all
duties, tasks, and responsibilities. Specific duties and
responsibilities may vary depending on department or program needs
without changing the general nature and scope of the job or level
of responsibility. Employees may also perform other duties as
assigned. DESIRED QUALIFICATIONS:
Experience developing reports and
dashboardsExperience with Smartsheet
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.
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.
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, .
The expected pay range for this position is $107,000 to $131,000
per annum. 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.
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 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.School of Medicine employees who
are patient-facing, work in, or frequent clinical and hospital
areas for work purposes are considered as healthcare workers. This
position is considered a healthcare worker and will need to comply
with the Stanford Medicine vaccination requirements including the
primary series of COVID 19 vaccines.
Keywords: Stanford University, San Leandro , Clinical Research Manager, Healthcare , San Leandro, California
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