What does a Clinical Research Associate (CRA) job do?

What does a Clinical Research Associate (CRA) job do?

According to the Association of Clinical Research Professionals (ACRP) a Clinical Research Associate (CRA) is:

A CRA supervises, monitors, and supports the administration and progress of a clinical trial on behalf of a sponsor. The sponsor, whose intent is the research of pharmaceuticals, biologics, or devices, may employ these individuals either directly or indirectly via contract research organizations (CROs), or as independent consultants or contractors.

Here is a summary and explanation of a Clinical Research Associate job description for someone not in the industry.

• A CRA is also called a "Monitor" as an alternate job name because of their main job role of "monitoring" clinical trials.  (Click here to read the blog post explaining what a clinical trial means.)  A clinical trial or "study" is a scientific way a new drug, biologic, or device is tested in humans so as to get regulatory approval to sell and use in a particular country.  
• A CRA is either employed by a Contract Research Organization (CRO) or sponsor. (Click here to read the blog post explaining who works on a clinical trial.) A Sponsor owns the new drug, biologic, or device being tested.  However, a sponsor may "contract" out managing their clinical trial to a CRO.  
• A CRA can be an employee or an independent contractor.  A contract CRA is actually a "CRO" company of that one CRA. 
• A CRA is assigned the management of sites where the study is being performed.  The CRA will be the main point of contact for the site about the study.  The CRA will occasionally travel to the site to "monitor" it.  
• During a site visit, the CRA will have different tasks to accomplish depending on the status of the clinical trial.   The CRA is generally meeting with the Principal Investigator and Clinical Research Coordinator during the visit. There are four main types of visits:
  1. Site Qualification Visit (SQV) / Pre-qualification Site Visit (PSV): A CRA will visit potential sites being considered for the study to determine if the staff and facilities are adequate.
  2. Site Initiation Visit (SIV): The CRA will train site staff on the protocol, review regulatory documents, and ensure all study materials are on site so the site can open the clinical trial to start screening and enrolling subjects.
  3. Interim Monitoring Visit (IMV): The CRA will review the subject's source documents and reconcile them with Case Report Forms (CRFs), study materials on site, and regulatory documents.
  4. Close-Out Visit (COV): This is the final study visit.  Study materials are returned if this was not done during an IMV.  A final review and reconciliation is done on the subject source files and regulatory documents to make sure they are complete.
• When a CRA is not traveling, the are "in house".  This can be at a work office or home office.  During this time the CRA may perform these job duties:
  1. Write "monitoring reports" which document what happened during a site visit.
  2. Email and call sites to discuss study updates and pending issues.
  3. Communicate updates to other study team members and reviewing clinical trial data.  This can be updating trackers, a clinical trial management system (CTMS), or other systems.
• A CRA receives therapeutic and protocol training before they start the clinical trial.  This happens for each trial.
• Before a CRA starts working for a particular company, they receive training on "Standard Operating Procedures" (SOPs).  These are guidelines that a Sponsor or CRO put in writing to state how everyone should perform various tasks on a clinical trial.

This is not a complete list of what a CRA does but a general description.  There is also another CRA role called the "Lead CRA" which has more of a clinical trial management focus.  That position will be discussed in more detail a later post.

Wikipedia has a job description posted here of Clinical Research Associate.

ACRP has a sample CRA CV posted here.

MedPace is CRO that has a few interviews of its CRAs on YouTube.  Here is one where a CRA explains her job:


A CRA can also becoming certified by ACRP.  Learn more about becoming a CCRA.

Learn more about Careers in Clinical Research
and how to become a Clinical Research Associate

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