Clinical Research Coordinator 2
Company: Stanford University
Location: Stanford
Posted on: October 17, 2024
Job Description:
Stanford University is looking for an enthusiastic experienced
Clinical Research Coordinator 2 to take on a leadership position in
our team and independently manage significant and key aspects of
large and multiple research studies at both Stanford's main campus
and satellite sites. We are seeking candidates with excellent
interpersonal skills, attention to detail, and will have a
demonstrated history of professionalism, initiative and
flexibility. Duties include*:
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
prepare/approve minutes.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 questions.Collaborate with principal
investigators and study sponsors, monitor and report serious
adverse events, and resolve study queries.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 study contract.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 DESIRED
QUALIFICATIONS:
Previous experience with
interventional drug and device studies.Ability to work
independently on multiple, complex research studies. Excellent oral
and written communication skills.Strong background in clinical
trials research, including protocol design, screening and
recruitment of potential participants, identification and
communication of adverse health effects.Must be flexible,
dependable, and able to handle multiple priorities with conflicting
deadlines.The position has a need for flexible work hours which may
involve day or nighttime coverage. Hours will change based on the
research needs of the Division.Must be able to work at multiple
sites.Previous patient care experience. 200 documented
hours.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.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.Comprehensive
understanding of scientific principles. General computer skills and
ability to quickly learn and master computer programs, databases,
and scientific applications.Strong analytical skills and excellent
judgment.Ability to maintain detailed records of clinical research
and outcomes.Ability to work under deadlines with general guidance
is essential. Excellent organizational skills and demonstrated
ability to accurately complete detailed work.CERTIFICATIONS &
LICENSES:Society of Clinical Research Associates or Association of
Clinical Research Professionals certification is preferred. May
require a valid California Driver's License.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:
This is an on-site position and may
require extended or unusual work hours based on research
requirements and business needs.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.Additional
WORKING CONDITIONS: May require extended or unusual work hours
based on research requirements and business needs.WORK 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 $84,856 to $97,021 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.At Stanford University, base pay represents only one aspect of
the comprehensive rewards package. The Cardinal at Work website ()
provides 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.Consistent with its obligations under the law, the
University will provide reasonable accommodations to applicants and
employees with disabilities. Applicants requiring a reasonable
accommodation for any part of the application or hiring process
should contact Stanford University Human Resources by submitting a
. 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.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.
Keywords: Stanford University, Watsonville , Clinical Research Coordinator 2, Healthcare , Stanford, California
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