Clinical Research Associate: Role, Responsibilities, Skills, and Salary

Introduction:

Clinical Research Associate may be employed directly by the sponsor companies of clinical trials or by Clinical Research Organizations (CROs)

CROs conduct clinical trials on behalf of the sponsor companies.

Clinical Research Associates (CRAs) are also known as Clinical Trial Monitors, trial Monitors or Field Monitor (FM).

The primary duty of clinical research associates is to ensure that the
rights, safety and well-being of participant in clinical trials are secured.

Below one sentence can define the role of CRA:

Clinical Research Associate acts as a liaison between the Sponsor and the site.

“Sites” are the hospitals where clinical trials are performed.

What do you do as a clinical research associate?:

1. Travel to (a lot!) and monitor clinical trial sites to ensure that ICH GCP guidelines, study protocol and other industry-specific regulations such as GCP (good clinical trial practics) are being followed correctly.
   
2. Identify the protocol deviations and record them in Database or eDC (electronic data capture). eDCs are the tool to capture clinical trial-related data.
   
3. Visit reports are prepared by clinical research associates.
   
4. Answer the queries raised by site staff such as CRC (clinical research coordinator).
   
5. They ensure data collected is accurate and verifiable. it is also called source data verification.
   
6. Depends on designation, they can manage clinical trial site payments and handle any ongoing negotiations.
   
7. Important documents archival are done by CRA.
   
8. They update the site contact list.
   
9. They respond to data management, Safety and other department queries as well.

Some quite specific responsibilities as per GCP section 5.18:

“Verifying that the investigator is competent and has sufficient resources And continue to be adequate throughout the trial duration to ensure that services, including laboratories, equipment and staff, are adequate to perform the trial safely and adequately and remain adequate throughout the trial.”

“verifying, for the investigational product(s):

• That storage times and conditions are appropriate, and that supplies during the trial are adequate.
  
• That the investigational product(s) are only supplied to subjects entitled to obtain it and at the dose(s) defined in the protocol.
  
• Clinical research associate ensures that all the necessary instruction on properly using, handling, storing, and returning the investigational product are given to subjects enrolled in the trial.
  
• Clinical Research Associate (CRA) ensures that there are sufficient monitoring and recording of the collection, use and return of the investigational product(s) at the testing sites
  
• Clinical research associate ensures that disposal of the discarded testing product(s) at the trial sites satisfies the relevant regulatory criteria and is compliant with the sponsor.

Other responsibilities:

CRA verifies that investigator follows the approved protocol and all approved amendment(s) if any.

Verifying that site has taken as written informed consent or not before enrolling any subject.

CRA ensures that all the source documents and other trial records are accurate, complete, kept up-to-date and maintained.

CRA checks the entries in eCRFs (Electronic Case report forms) and double-checks with Source data. Case report forms are the documents which are used to capture clinical trial protocol. clinical research co-ordination enters the data in CRF.

CRA checks the below information in CRFs:

• CRAs check if the site has entered all the required data in CRFs or not
  
• The correctness of any dose and/or therapy modifications -documentation
  
• Adverse Events, concomitant medication and Medical history are properly documented or not
  
• Missing visits, Discontinuation of subjects, death are properly captured or not.

Monitoring Report

• CRA has to submit a written report to the sponsor after each site visit
  
• Monitoring reports include the following component:
  
• Date, site, name of monitor, and name of investigator
  Any finding, if any action is taken

How do I become a clinical research associate?:

• You should have a degree in Pharmaceutical science, or any life science subjects
  
• Degree, exclusively in clinical research is not needed but it may help you to build a better understanding.
  
• Basic understanding of clinical research such as Phases of trials and types, the drug approval process of various countries especially of the major market such US, EU, Japan, India and China.
  
• Aspirants for CRA jobs should be well versed with clinical trial terminologies, GCP (Good clinical practice) and ICH guidelines.
  
• Basic knowledge of Microsoft excels, Word and PPT
  
• Good communication skills 
  
• Last but most important thing you must be ready to travel a lot!. It is said that CRA should take home near Airport because travelling is quite more in this Job.

How much do clinical research associates get paid?:

Average Salaries were calculated from four different sources: payscale.com, prospects.ac.uk and Glassdoor (as of May 2020)

It is necessary to have a good understanding about other job roles as well in Pharma and CRO industries so that if you can develop other skills as well to match the market demand and your expectations.