The role of the clinical research coordinator – data manager – in oncology clinical trials

Abstract

BackgroundThe purpose of this study was to determine the standard tasks performed by clinical research coordinators (CRCs) in oncology clinical trials.MethodsForty-one CRCs were anonymously surveyed, using a four-page self-administered questionnaire focused on demographics, qualifications, and professional experience. The survey questions on responsibilities consisted of an ad-hoc 32-item questionnaire where respondents had to rate the frequency of involvement in the listed activities using a 3-point scale. We defined as "standard" a task that was rated as "in all or nearly all trials" by at least half of the respondents.ResultsA response rate of 90% (37 out of 41) was achieved after two mailings. Less than half of the respondents had received additional training in oncology, clinical research or Good Clinical Practices (GCP). Overall, all standard tasks performed by CRCs were in the category of "monitoring activities" (those usually performed by a Clinical Research Associate "CRA") and included patient registration/randomization, recruitment follow-up, case report form completion, collaboration with the CRA, serious adverse events reporting, handling of investigator files, and preparing the site for and/or attending audits.ConclusionsCRCs play a key role in the implementation of oncology clinical trials, which goes far beyond mere data collection and/or administrative support, and directly contributes to the gathering of good quality data.

Recruitment to randomised trials: strategies for trial enrolment and participation study. The STEPS study

“…Although there are some reports of the views of nurses 54,55 and some of the views of GP recruiters, 37,56-58 the research samples available are largely comprised of senior doctors involved in trials, with a strong bias towards oncology trials. 32,[41][42][43]45,59,[60][61][62] No research was identified that describes the attitudes of coordinating staff [although see Rico-Villademoros and colleagues 63 for a survey-based description of the role of the clinical research coordinator (data manager) in oncology trials].…”

Cross-sectional Study on Occupational Stress of Clinical Research Associates in China

“…Studies had been carried out about the burnout of medical professionals, nurses, pharmacy technician, CRC, and other precarious employment [14][15][16][17][18]. Clinical monitoring is characteristic of responsibility, complication, time-effective and nomistake, and the CRAs are likely to develop occupational stress when resource contest, extra burden, or insufficient training occurs.…”

Role of the Clinical Research Coordinator in Orthopaedic Research: Making Research Less Onerous

“…Historically, the CRC's role was focusing on responsibilities of help with patient recruitment, obtaining informed consent from subjects, and helping collect data and now has involved into taking responsibility for numerous facets of conducting and making sure the research is done in accordance with the law and adheres to steps outlined by regulatory bodies (Table 1). 1 Given the numerous tasks allotted to the CRC for maintaining, the work demand can be extremely onerous for the CRC. In fact, a survey of 1597 CRC showed that 42% of CRCs reported working more than 40 hours per week.…”