Study coordinator
The study coordinator is generally considered the
linchpin in the day-to-day activities of clinical
research. Without this key individual, sites would
be hard pressed to perform studies in a quality and
timely fashion because the coordinator’s responsi-
bilities define clinical trial conduct.
The coordinator’s job is detail-oriented and
includes responsibilities such as (Miskin and
Neuer, 2002)
patient recruitment activities
completing case report forms (CRFs)
transmitting study data
scheduling patient visits
meeting with principal investigators
meeting with study monitors
shipping samples to laboratories
maintaining inventory and accountability of the
investigational product
closing out the study
participating in preparing proposals for solicit-
ing new studies
participating in budget preparation
attending investigator meetings
participating in ongoing training
collecting metrics.
Today’s quality sites often encourage study coor-
dinators to become certified either by the Associa-
tion of Clinical Research Professionals (ACRP), an
international organization with chapters in more
than a dozen nations, or the Society of Clinical
Research Associates (SoCRA), an organization
with chapters in some half-dozen countries. The
ACRP certification is known as ‘Certified Clinical
Research Coordinator’ (CCRC), and SoCRA’s cer-
tification is the ‘Certified Clinical Research Profes-
sional’ (CCRP).
To achieve either of these designations, the coor-
dinator must sit for an examination following spe-
cified amounts of either full-time or part-time
experience by the date of the examination as
defined by either organization (www.acrpnet.org
and http://www.socra.org). The examinations test knowl-
edge in study conduct, regulations and ethical
issues.
A major issue in clinical research today is that of
the overwhelmed study coordinator. Because of
the ever growing number of details that comprise
clinical studies, coordinators can easily become
bogged down and, ultimately, very frustrated.
This situation can lead to a decline in work quality
or a high level of employee turnover. According to
a recent survey, 53% of study coordinators have
been in their jobs for three years or less (Borfitz,
2004). This poses real challenges in terms of
experience level, knowledge of GCP and familiar-
ity with site operations.
Sites interested in retaining their trained and
certified coordinators are exploring ways to
improve retention. This includes offering good
compensation and benefits, offering ongoing train-
ing and making decisions to hire more full- or part-
time coordinators if the workload expands beyond
the capacity of the existing staff complement.Director of clinical operations (DCO)
The DCO is the point person for daily clinical
operations. He is the individual who interfaces
with sponsors, investigators, study coordinators
and other professional staff on a regular basis to
oversee clinical and budgetary status of ongoing
and upcoming studies. Because of the intense,
close attention to detail that the job demands, it
makes sense to fill this positionwitha highlydetail-
oriented individual with an understanding of the
clinical trials process.130 CH11 SITE MANAGEMENT