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CRA

What is a CRA?


 A clinical research associate (CRA) is someone who monitors the running of clinical trials. A CRA may be involved in some or all stages of the process depending on the type of position or the employer. typically, the key responsibilities of a CRA will include monitoring study sites and clinical activities, updating study documentation, maintaining clinical data systems and coordinating research procedures. 


If you are a field-based CRA, you will spend most of your time travelling to different locations, dealing with medical professionals in trial centers, healthcare practices, or hospitals. The remainder of your time may be spent either office-based or working from home, but this will depend on the company. Some companies will have in-house CRA roles who just focus on document review and management and will make site visits only occasionally.

The Clinical Research Associate program is designed for beginner level CRA's in the clinical research industry. CRA's work remote and are expected to travel for a day or two to one of their assigned sites each week for a monitoring visit.


The CRA training course is led by tenured Clinical Research Associates that have worked at the top clinical research sites in the United States. Focused on prepping our students for successful job placement, the CRA training provides a comprehensive introduction to clinical research and the job functions of the Clinical Research Associate (CRA) for drug, biologic, and device trials. Case studies and industry best practices are presented to emphasize how the learning objectives apply directly to the responsibilities of the CRA. Upon successful completion of the curriculum, we provide each student with resume assistance so that you are in the best position to successfully enter into the field.


 

According to CNN Money, the Clinical Research Associate profession is one of the best jobs in America. 


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BEST JOBS IN AMERICA

CNNMoney/PayScale.com's list of great careers


Clinical Research Associate:


  • Median pay: $115,300

  • Top pay: $150,000

  • 10-year job growth: 36.4%


 

What they do all day?

Where there's a clinical trial, clinical research associates are making sure it's going the way it should. That means monitoring procedures and results and making sure that researchers are following proper protocols at every step.​


What makes it great?

Since there are so many different types of clinical trials, the work environment can be dynamic with tasks varying from day to day. CRAs can specialize in a particular subject area, or go for a broad base of knowledge and hop from topic to topic. And growth potential is strong: As personalized medicine becomes more common, clinical trials will increasingly be needed to make sure drugs and devices work properly.


How to get the job?

A bachelor's in any field but preferably in science, sociology or psychology is a good foundation, as is experience in a clinical trial environment or in health sciences. Minimum requirement is a bachelors degree in any field from any school!


What's the catch?

Most CRA jobs require at least some travel regionally, if not nationally or internationally, which can mean long hours and lots of time away from family.


AM I QUALIFIED?

A bachelor's in science, sociology, psychology or any field is a good foundation. Please note that science based degrees are not mandatory. Experience in a clinical trial environment or in health sciences is also valuable.Some employers look for a CRA certification, such as the one offered by the Association of Clinical Research Professionals (ACRP) as well.

Some employers look for a CRA certification, such as the one offered by the Association of Clinical Research Professionals (ACRP) as well.







CRA Essential Duties

As defined by the Academy, and determined through ACRP’s 2015 Job Analysis Survey, clinical research associates who are eligible for CRA Certification must document cumulative performance of each of the following essential duties during the dates of employment listed on the application.


Verify that the research site investigator(s) and study personnel are conducting the study according to the clinical protocol, “Good Clinical Practices”, and regulatory requirements to ensure protection and ethical treatment of human subjects.


Ensure identification and reporting of safety issues, when applicable, from research site staff to the sponsor and the IRB/IEC.


Perform monitoring activities per the monitoring plan (e.g. verification of source documents and eCRF/CRFs, site communications, follow up on data anomalies, etc.).


Review accuracy and completeness of site records (i.e., essential documents, query resolution, and other data collection tools).


Ensure accountability of Investigational Product and related supplies are performed, when appropriate.

Ensure complete reporting and proper documentation of monitoring activities.


Conduct routine monitoring visits (on site or remotely) independently from the investigative site study staff.