Roles of Clinical Research Team Members
The relevance of a competently constituted clinical research team cannot be overstated when it comes to the success of clinical trials. This is true for both a site-based clinical research team and a sponsor-based clinical research team.
Sponsor-Based Clinical Research Team
Data Coordinator
According to Robinson (2009, p. 9), "the primary role of a data coordinator is to ensure that the clinical trial database is accurate and complete, ready for data analysis."
Education Requirements
A degree in a biological science (Robinson, 2009)
Professional Skills
Some of the most important professional skills a data coordinator ought to possess are "an eye for detail and methodical approach" (Robinson, 2009, p. 9).
Experience Requirements
Like any other key role in clinical research, experience in this case does matter. In most cases, 2-3 years worth of experience is deemed sufficient.
Interpersonal Skill Requirements
According to Robinson (2009), of key relevance to this position is the ability to communicate well with others and exhibit good interpersonal skills.
Job Responsibilities
1. Conduction of standard quality control checks on data via undertakings such as "running data validation programmes on the database" (Robinson, 2009, p. 9).
2. Data coding. Here, the data coordinator, in the words of Robinson (2009, p. 9), codes "verbatim terms to preferred terms…"
Adverse event reports reconciliation with the CRF data. This the data coordinator does so as to resolve any discrepancies that arise and ensure that the relevant information matches (Robinson, 2009).
Interacting with Team Members
Data coordinators, as Robinson (2009) points out, are expected to forge close working relations with CRAs so as to ensure that data queries that arise from case report sheets are resolved in a timely manner.
Site-based Clinical Research Team
Role: Clinical Research Coordinator
In essence, "by far the most essential role fulfilled by the CRC is to protect the safety and well-being of the research participants" (Fedor, Cola, and Pierre, 2006, p. 2).
Education Requirements
A basic BS/BA degree. Relevant certifications such as ACRP or CCRP
Professional Skills
Clinical research coordinators ought to be well versed with the various guidelines for research as well as possess sound knowledge of patient confidentiality and privacy procedures and policies.
Experience Requirements
A significant percentage of clinical research coordinators have nursing backgrounds (Fedor, Cola, and Pierre, 2006). Experience in other healthcare occupations could also be valid, depending on the clinical trial's therapeutic area (Fedor, Cola, and Pierre, 2006).
Interpersonal Skill Requirements
Given the multi-level nature and responsibilities of this role, the position holder should be a good communicator. He or she should be…
