Protocol Coordinator
- United States
- Remote
- Full-time
- Mid Level
- Posted
This
position
is
listed
on
behalf
of
a
partner
company,
who
manages
all
applications
and
next
steps.
Our
partner
is
looking
for
a
Protocol
Coordinator
based
in
the
United
States
.
The
Protocol
Coordinator
will
play
a
key
role
in
supporting
the
development
and
management
of
clinical
research
trials
focused
on
childhood
and
adolescent
cancer.
Working
closely
with
investigators,
scientific
committees,
statisticians,
and
multidisciplinary
study
teams,
you
will
oversee
the
creation
and
maintenance
of
essential
study
documentation.
You
will
coordinate
protocol
development
from
initial
study
concepts
through
amendments
and
final
study
closure,
ensuring
accuracy,
consistency,
and
compliance
with
established
guidelines.
The
role
combines
scientific
writing,
project
coordination,
and
clinical
research
expertise
in
a
collaborative,
mission-driven
environment.
You
will
help
translate
complex
scientific
and
clinical
requirements
into
clear,
comprehensive
documents
that
support
successful
trial
implementation.
This
is
an
opportunity
to
contribute
to
groundbreaking
research
initiatives
and
make
a
meaningful
difference
in
the
lives
of
children
and
families
affected
by
cancer.
Accountabilities
Clinical
Protocol
Development:
Lead
the
development,
drafting,
review,
and
maintenance
of
clinical
research
protocols
in
collaboration
with
study
chairs,
scientific
committees,
investigators,
statisticians,
and
other
study
team
members.
Document
Coordination:
Prepare
and
maintain
study-related
documentation,
including
protocol
amendments,
informed
consent
forms,
youth
information
sheets,
laboratory
and
pharmacy
manuals,
training
materials,
and
other
supplemental
documents.
Review
and
Approval
Management:
Coordinate
internal
and
external
review
and
approval
processes
throughout
the
clinical
trial
lifecycle,
from
initial
study
concepts
to
study
closure.
Study
Planning
and
Activation:
Establish
development
objectives,
communicate
deadlines,
coordinate
weekly
study
meetings,
and
facilitate
kick-off
discussions
to
ensure
timely
study
activation.
Scientific
Documentation:
Design
experimental
study
schemas
and
therapy
delivery
maps,
maintain
standardized
protocol
language,
and
ensure
all
clinical
and
research
requirements
are
accurately
represented.
Quality
Assurance:
Review
case
report
forms
and
supporting
documentation
for
consistency
with
approved
protocols,
address
document-related
queries,
and
ensure
compliance
with
departmental
procedures.
Stakeholder
Collaboration:
Facilitate
communication
between
investigators,
study
committees,
research
coordinators,
institutional
clinical
research
associates,
and
external
research
organizations.
Study
Management:
Identify
documentation
inconsistencies,
track
protocol-related
issues,
coordinate
necessary
amendments,
and
prepare
study
updates
for
publication
on
relevant
platforms.
Administrative
Coordination:
Maintain
accurate
study
records,
monitor
key
milestones,
attend
scientific
and
operational
meetings,
and
support
additional
research
and
documentation
projects
as
needed.
Requirements
Bachelor's
degree
in
a
life
sciences
or
related
field,
or
an
equivalent
combination
of
education
and
experience,
including
four
additional
years
of
relevant
professional
experience.
Previous
experience
in
clinical
research
trials
and
clinical
trial
protocol
development.
Strong
understanding
of
clinical
trial
components,
including
study
methodology,
statistics,
informed
consent,
eligibility
criteria,
and
adverse
event
reporting.
Approximately
2–3
years
of
scientific
writing
experience
involving
clinical
protocols,
published
manuscripts,
research
grants,
or
other
scientific
documentation
is
highly
desirable.
Experience
in
clinical
research,
life
sciences,
or
a
related
scientific
field
is
preferred.
Demonstrated
ability
to
research,
interpret,
analyze,
and
evaluate
complex
scientific
information
accurately.
Excellent
written
and
verbal
communication
skills,
with
s
How Jobgether works
- We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
- We appreciate your interest and wish you the best!
- Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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