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.

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Clinical Research Coordinator (CRC) Career in Managing Research Trials

A Clinical Research Coordinator (CRC) is a career in managing research trials.

A "Clinical Research Coordinator" (CRC) is also called a "Study Coordinator" (SC).  The terms are used with equal frequency.  Most people say "Study Coordinator" since it is shorter; however, the Association of Clinical Research Professionals (ACRP) provides a certified CRC certificate.

ACRP defines the CRC role as:
"A CRC works at a clinical research site, with study subjects, under the immediate direction of a principal investigator, whose research activities are conducted under GCP guidelines."

But what does this job description mean?

A clinical research site is a place where is "clinical trial" is conducted.  (If you are unsure what a clinical trial is then read this blog post.)  A Sponsor (drug, device, biotech) of a trial will find medical clinics to offer an "Investigational Product" (IP).  A clinic will enroll patients into a clinical trial.  Once a patient decides to participate in a trial then the person is referred to as a study "subject".  There is at least one physician (or someone of appropriate training) who will oversee the trial at the trial at the clinic called the "Principal Investigator" (PI). (To learn more about study roles, read this blog post.)  The PI will provide guidance to the CRC, but the CRC mainly works independently to manage the clinical trial at the site.  The word "GCP" refers to "Good Clinical Practice".  It is a set a guidelines (country specific) on how a clinical trial should be conducted.

Some of the responsibilities of a CRC with patients/ study subjects include:

• Performing a chart review on clinic patients to see if any potentially qualify for the study.  If they do then call the patient to see if they want to come in for the study.
• If the PI has a patient in the office for a clinic visit who is interested in the study then the CRC will help explain the study and required office visits/ procedures to the potential subject.
• If the site is advertising the study, then the CRC may discuss the study with people who are not regular patients of the clinic but want to participate in the study.
• If a patient is interested in enrolling in the study, the the CRC will review a document called the "Informed Consent Form" (ICF).  This document explains in writing the study procedures, risks, safety information, and rights of a study subject.
• Once a patient becomes  study subject, the CRC will coordinate the office visits, as well as, follow-up contacts between visits.  The CRC is often the main person that works with the study subject during the clinical trial.
• At office visits, the CRC will ask a subject about past medical history, take vital signs, draw labs samples (if needed), administer questionnaires, and give instructions to the subject on how to comply with the study protocol requirements.  The CRC will ensure the PI meets with the subject as needed and updates the PI on the subject's health and status. 
• Between office visits, the CRC will contact the subject to give reminders about study visits, ask about the subject's health, and answer study questions.
• The CRC records all their subject interactions in records called "source documents".  A source document is considered the first place a piece of data is written and could be a piece of paper, an x-ray, or captured directly in an electronic medical record (EMR).
• The CRC will take the source document data and transfer it to a "Case Report Form" (CRF).  This is a data form that will transmit the study data (questionnaire answers, vital signs, physical exam results) to the Sponsor.  The reason it needs the study data needs to be entered into a CRF is so that it removes "personal health information" (PHI) that would allow a subject's identity (name, address, local medical records numbers) to become known to the sponsor. 

A CRC also works with Sponsor or Contract Research Organization (CRO) staff.  Here are some of those responsibilities:

• The Sponsor/ CRO matching role can be considered to be the "Clinical Research Associate" (CRA) which is also called the "Monitor".  The CRA acts a study liaison with the site providing study updates.  The CRA will occasionally visit the site for training or to review data.  Between office visits, the CRA will contact the CRC to provide study information and ask certain study tasks be completed.
• The CRA will compare the source documentation to the CRF during the visits.  If the source data conflicts or is missing in the CRF, then the CRA asks the CRC to resolve or clarify the issue.  CRAs are not allowed to change data.  They can only review it.  The CRA will give the CRC a "data clarification form" (DCF) also known as a "query".  
• Once the CRF data is transmitted to the Sponsor or CRO, many other staff will look at it and may also issue DCFs too.

The CRC works with an independent Ethics Committee (EC) or Institutional Review Board (IRB). (IRB is the term used in the United States and EC is used by the rest of the world.) The EC/IRB is a group (per local country guidelines) that oversees the trial.  Responsibilities of reporting to the EC/IRB include:

• Completing the initial application and obtaining approval to have open the clinical trial at the site.
• Answering questions that the EC/IRB may have about the study.
• Providing updates to the EC/IRB on the study's progress including safety updates and any significant site errors or problems with the study.
• Notifying the EC/IRB once the study is complete.

There are additional responsibilities than those noted above, but this is a general guideline.  The PI is also overseeing and is responsible for the CRC's work throughout the trial.  Larger clinics break up the CRC's responsibilities such as having one staff focus on recruitment, one person for processing and shipping lab samples, and another for handling all EC/IRB communications and regulatory documents.

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HarvardX Free Course in Fundamentals of Clinical Trials

HarvardX is offering a free course in Clinical Trials.  The original course already has ended but you can enroll for free and learn from the archived lessons.  Here is the link for the classes:
https://www.edx.org/course/fundamentals-clinical-trials-harvardx-hsph-hms214x#

Fundamentals of Clinical Trials

Clinical trials play a pivotal role in evidence-based medicine. This course will discuss the design, conduct, analysis, and interpretation of Phase I-IV clinical studies.

What you'll learn

Fundamentals of Clinical Trials Free Harvard X Course

• The scientific, statistical, and ethical aspects of clinical trials research
• How to design, implement, and analyze data from clinical trials
• How to interpret results from clinical trials
• The ethical issues that arise at each phase of therapy development

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Who Works a Clinical Research Trial?

Who Works on a Clinical Research Studies or Trials?

The Sponsor overall is responsible for the trial conduct; however, the Sponsor outsource work to another company called a "Contract Research Organization" or CRO.  The Sponsor and CRO work together in overseeing the study.  There may be one or multiple CROs involved in a clinical trial.

The Sponsor or CRO will find different doctors called "Investigators" in many different locations who agree to follow the protocol and will administer the  Investigational Product at their clinic.  The lead doctor is called the "Principal Investigator" and manages oversight of the study at the clinic.  There may be additional staff (doctor, physician assistant, nurse practitioner) who are responsible for performing key study assessments and they are called "Sub-Investigators". The Investigator is assisted by a "Study Coordinator" (SC) or "Clinical Research Coordinator" (CRC) at the medical clinic who helps the doctor to manage the administration of the study.   A CRC can be a nurse, medical assistant, or other clinic staff.  A position that links the Investigator's sites to the Sponsor/ CRO is called a "Clinical Research Associate" or CRA.  The CRA works on behalf of the Sponsor or CRO to oversee the site.  This means reviewing all the study documents (medical records, trial data, study correspondence) to ensure that the clinical trial is being conducted according to the protocol and regulatory requirements.  If CRA provides training and feedback to the site staff to ensure to help them keep compliant.  Overall the Investigator is responsible for all work done at the site but the CRA works in collaboration with the site to make sure quality research is being performed.  The CRA travels to the different clinics to perform this review and mainly works with the CRC during these "monitoring visits".

Clinical research seeks to find cures for cancer, diabetes, genetic diseases, and more.  Clinical research professionals work as a team to innovate these medical breakthroughs.

This was a general overview of only some of the jobs that manage a clinical research trial or study.  A career in this field means learning how to protect the safety and well being of humans who participate in these trials while looking for the next generation of medical healthcare treatments.

The above information was tested for clarity in conversations with taxi cab drivers on trips to and from airports.

- Article by Laurel Latto, Certified Clinical Research Associate (CCRA)

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What is a Clinical Research Study or Trial?

What is a Clinical Research Trial?

A clinical research trial or study comes about when a biotech, pharmaceutical, or device company wants to get regulatory approval for its product to market it.  In order to get the approval of an agency like the FDA, it is required to conduct research in humans or a "clinical trial".  The company that has the product is called the "Sponsor" of the clinical trial.  The product that is going to be studied can be a drug, device, molecule, or a combination of them and is called the "Investigational Product" or IP.  The Sponsor then comes up with a plan on how the clinical trial will be run.  These instructions also include safety and background about the Investigational Product.  The plan is called a "protocol" whose main purpose is to answer questions about how the IP works in  humans who participate in the trial.  The clinical trial can be in one country or can be worldwide in multiple countries.

Clinical research seeks to find cures for cancer, diabetes, genetic diseases, and more.   Clinical research professionals work as a team to innovate these medical breakthroughs.

A career in this field means learning how to protect the safety and well being of humans who participate in these trials while looking for the next generation of medical healthcare treatments.

The above information was tested for clarity in conversations with taxi cab drivers on trips to and from airports.

- Article by Laurel Latto, Certified Clinical Research Associate (CCRA)

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Learn about Careers in Clinical Research

What is a Career in Clinical Research?  

Learn about Careers in Clinical Research

This is a question that most people don't the answer to it and as a result don't know about careers in the field.  When I as a new college graduate, I didn't know this answer either.

I landed at a biotech company in San Diego, California and learned about this field.  I had gone to college at the University of California at San Diego, majored in biochemistry because it was a good pre-medical major, and planned to become a surgeon.  As time went on in college, I became more interested in art and even got a visual art minor.  Going to medical school meant for me giving up on ever being an artist given the time commitments to a medical career.

I graduated confused and felt like a failure because I did not know what I wanted to do with my life.  I had done an undergraduate internship in at an orthopedic research lab looking at cross sections of monkey muscle fibers that had atrophied during space flight.  It sounds great but the reality was hours of repetitive tasks not talking to anyone else in a lab that had no windows.  I knew from that I never wanted to do laboratory work as a career but what could I do with only a bachelor's degree in science?

Since I did not want to lab work, I had no other significant job skills and I also wanted to see if I could land some freelance art jobs even though I had no portfolio.  To make ends meet, I worked as a temporary office employee earning minimum wage up to $2 over it an hour.  One day I was placed as a local biotech.  They quickly realized I was much more capable than basic administrative tasks and kept giving me additional work responsibilities.  They even increased my pay by a $1 an hour.  I was engaged with my work, able to pay most bills, and had time to work on my art but it was still a financial struggle.

One day, a co-worker took me aside.  Dinah explained how she was a concert pianist but had found a way to have both a career and time for art through clinical research.  She said I should become a clinical research associate (CRA).  I had heard and seen the CRAs around the office but didn't really understand what their job role was other than they traveled regularly to medical clinics around the country for the research study.  I asked the different CRAs for informational interviews about their jobs.

I talked to about 5 CRAs but I remember most the conversations I had with two contract CRAs.  One was the sole provider for her family while her husband stayed home with the kids.  She noted that while she traveled, she would potentially put in 10 hour days, but the money she earned allowed her to take off time to not work during the summers and be with her kids.  Another CRA was a photographer.  He noted how in between jobs he used the money he made to work as a photographer.

I had heard enough and decided to become a CRA.  One of the biotech CRAs referred me to a company called Quintiles where he used to work and I was hired.  I was lucky in that I had access to people in the industry who provided me with informational interviews and gave me referrals into the industry.  Over the years, I have shared my passion for this industry and helped a dozen people find or advance their clinical research career.  I want to pass that opportunity on to others by sharing what I know through this blog and my website www.pictureyourselfin.com.

As for what a career in clinical research means, I will explore that more in future posts!  As for my art, I did find time for it.  It actually overlapped with my personal experiences in clinical research.  I started a 501(c)3 charity called, DonnaBellas Angels (www.donnabellasangels.org) which has a motto "Medicine Heals the Body, Art Heals the Soul".

Article by Laurel Latto, Certified Clinical Research Associate (CCRA)

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