The Senior Clinical Research Associate: a cornerstone of Clinical Trial Operations




What is a Clinical Research Associate?

Of the many different people and roles needed to execute a clinical trial successfully, the Clinical Research Associate, or CRA, is at the core.

The Association of Clinical Research Professionals (ACRP) defines a CRA as someone who, “supervises, monitors, and supports the administration and progress of a clinical trial on behalf of a sponsor”.  The role of a CRA is often associated with monitoring a clinical trial during enrollment, but may also include supporting protocol development, or qualifying, initiating, training, managing, and closing investigational sites.

One model for using CRAs to execute a clinical study is for a sponsor or clinical research organization (CRO) to split CRA responsibilities between several groups of CRAs. For example, a sponsor may employ in-house CRAs, who are responsible for coordinating with site personnel, maintaining the sponsor Trial Master File, and for working with teams from CROs or Data Management Organizations (DMOs). Under this model, a separate team of CRAs may train site personnel on the study protocol and investigational product (i.e., pharmaceutical or device). Sometimes these CRAs are called Clinical Specialists or Study Proctors.  Another team of CRAs may be responsible for source data verification, or monitoring, which is required by Good Clinical Practice (GCP) to verify that study participants’ rights and well-being are protected, the data are accurate and complete, and that the trial has been conducted in compliance with the protocol and applicable regulations.  GCP allows the sponsor to assign any or all of these components of study operations to a CRO, but requires the sponsor to maintain ultimate responsibility for the integrity of the trial. Another CRA model, particularly of use when contracting with a CRO, is to enlist members of the CRA team with expertise in all facets of clinical trial operations. These experienced CRAs will often have the title of Senior CRA.

The Senior CRA Advantage

A Senior CRA has extensive experience in executing clinical trials and will often take on higher levels of responsibility.  He or she may be intimately involved in the creation of regulatory strategy, development of the study protocol, timeline, and/or budgets. A Senior CRA may also develop other study support materials, such as data collection tools, training tools, monitoring plans, and other study plans. For example, the Senior CRA may work closely with the study statistician to develop the statistical analysis plan. Additionally, a Senior CRA may be responsible for clinical project management and will oversee various aspects of the project, such as timelines, budgets, other CRAs, and key external vendors like CROs, DMOs, or Clinical Events Committees, a type of physician oversight board.

In order to be successful in managing higher levels of responsibility in clinical trials, and to become a Senior CRA, an individual is often required to have at least five years of work experience as a CRA, sometimes in a targeted therapeutic area, like diabetes care or coronary stents, and to be able to work independently.  Many Senior CRAs have specialized clinical experience as a cardiac nurse or radiology technician, for example, so they are well equipped to train physicians on new drugs or devices. Increasingly, Senior CRAs have demonstrated their expertise via certification from an accredited program like the Society of Clinical Research Associates or the Association of Clinical Research Professionals.

The range of experience of a Senior CRA may vary, however, so it is important to evaluate each potential member of the CRA team to ensure that he or she has the skills necessary to make a given clinical study operate efficiently. The more a CRA team’s skillset can be tailored to a given study and the more senior the members, the more likely the trial will be completed on time, with accuracy and integrity.  To learn more about HCC’s Senior CRA’s, click below: