November 2024 SOCRA Source Journal - Journal - Page 62
Clinical Research Coordinator
As an acting CRC, the D-PRIME
learner supports clinical research
studies within Pediatrics across
multiple specialties. The CRC role
facilitates the day-to-day clinical
research operational activities
in adherence to Good Clinical
Practices (GCPs), study protocols,
regulatory requirements,
institutional guidelines, and
sponsor expectations with
research project manager
oversight. Responsibilities
include initiating new trials,
coordinating the recruitment,
screening and enrollment of
eligible patients, extracting
and reporting quality patient
data, processing biological
samples, and responding to
data queries (see Table 1 for
a more comprehensive list of
CRC duties).
The PEDS CRS team is staffed
by personnel with diverse
experiences and professional
backgrounds, allowing for
colleagues to be valuable
resources for one another in
learning different aspects of
clinical research otherwise
referred to as near-peer
mentorship. This has many
advantages in a 昀椀eld as
varied and broad as clinical
research. For example, there
are opportunities to learn
about clinical research from the
perspectives of the various roles
on the team, including, director,
project managers, regulatory
specialists and clinical research
coordinators. This is a large team,
working on a high volume of
different types of studies in many
pediatric therapeutic areas so
there is so much to learn. As part
of CRC onboarding and training,
new CRCs work with their
project manager to schedule
and facilitate shadowing of
personnel in different medical
specialties within the PEDS CRS
department. Each pediatric sub-
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TABLE 1
Clinical Research Coordinator duties
CLINICAL RESEARCH COORDINATOR DUTIES
Implement processes and organize efforts within
the study team to achieve objectives, coordinating
research procedures, study visits, and follow-up care
Create and maintain tools and documentation
to track study metrics, also providing updates to
management
Research
Facilitation
Recruit, screen, and enroll study participants, and
obtain consent from study participants
Collect and maintain source documents (patient and
laboratory data, etc.) and report adverse events
Work directly with study participants and families
and serve as project liaison to other departments,
outside organizations, and government agencies
Engage with clinical investigators to ensure accurate
interpretation and recording of data as well as the
maintenance of subject research charts
Assist with the preparation of regulatory
applications, consent forms, etc.
Regulatory
Prepare for and conduct pre-study activities, site
quali昀椀cation, study initiation, monitoring visits, and
close-out activities
Track regulatory review submissions to ensure
deadlines are met
Manage regulatory binders
specialty has different intricacies
that must be considered when
providing clinical research
support. This is valuable for
the D-PRIME learner, an acting
clinical research coordinator,
and this experience also
contributes to professional
development aspects as it
allows the learner to observe
subtle differences in practice
and processes. Opportunities
for personal development
SOCRA SOURCE © November 2024
are also available within the
PEDS CRS department such
as participation in workgroups
and committees, attendance
at seminars, and funded travel
for professional development
activities including conferences
and certi昀椀cations. The
D-PRIME learner was able to
help develop the PEDS CRS
social committee, dedicated
to planning social work events
to promote an inclusive,
