CRA Skills & Education Requirements


The CRA career path requires significant investment in education and skills in order for one to be successful. Let’s break down the education requirements and CRA skills you’ll need to land a job and progress in your career as a CRA.

Education for CRAs

Although there are no exact rules, the general educational requirement for a CRA role is typically a Bachelor of Science (BS) or a Bachelor of Art (BA) degree in life sciences, medical sciences, or healthcare related field such as nursing.

An advanced degree is not required, but it can be helpful for career progression as a CRA. An advanced degree can help you stand out from the crowd if you plan on taking on a leadership role, or if you are planning on being highly specialized in your clinical research field.

Certification and Training

Getting certified is another way to show you can go the extra mile to potential employers. Although not always required, certification can be very advantageous in some situations. Common certifications include Certified Clinical Research Associate (CCRA) from the Association of Clinical Research Professionals (ACRP) and Certified Clinical Research Professional (CCRP) from the Society of Clinical Research Associates (SOCRA).

On the job training goes hand in hand with some of the CRA skills mentioned below. Entry-level CRAs typically undergo a period of training under the supervision of experienced professionals. This training includes learning specific protocols, regulatory requirements, and detailed reporting procedures.

CRA Skills

CRAs perform variety of functions related to the effective execution of clinical trials. As different functions require different skill sets, below are some skills that can be helpful in a CRA’s job performance:

  1. Excellent communication skills (both written and oral)
    This is important as CRAs work with clinical trial sites (Principal Investigator and staff), regulatory review boards, key opinion leaders (KOLs), and colleagues.
  2. Ability to motivate and train others
    This goes along with the communication skills. CRAs will need to train and monitor the progress of clinical trial conduct at different clinical sites.
  3. Attention to detail
    CRAs will need to be able to see mistakes and identify incorrect trial data / results. The work also involves documentation and recording of information. Detail oriented skills is critical to the monitoring work to ensure that clinical trial results are recorded appropriately and are accurate based on source data on medical records.
  4. Problem solving skills
    Unexpected events and issues often will come up throughout different phases of clinical trial. CRAs are the main contact for all the issues that may come up. Thus, CRAs should maintain flexibility and positive approach toward unexpected issues.
  5. Multi-tasking, time management, and organizational skills
    Multi-tasking skills are essential as CRAs are often handle different tasks at the same time. Time management skills are the key to effective work schedule arrangement in order to avoid overload. Organizational skills will help CRAs when working with stringent record keeping and regulatory requirements from regulatory bodies that regulate clinical trials.
  6. Analytical CRA skills
    CRAs will need to possess the ability to analyze clinical data and to interpret and understand different regulatory requirements.
  7. Ability to travel
    Although travel can vary depending on the type of position, CRAs are expected to travel to clinical sites as needed. Ability to handle travel both domestically and internationally is one of the skills needed for CRAs.
  8. Knowledge of good clinical practice (GCP) & FDA Code of Federal Regulations (21 CFR 11, 50, 56, 312, 812, 45 CFR 46)
    These are some of the documents that govern clinical trial conduct. Familiarity with these documents is essential. If you are new to the industry, they can be learned.

Author

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Ernie Sakchalathorn

Polachai Ernie Sakchalathorn is the founder of ClinicalResearchAssociateCRA.com and has been in clinical research since 2007. While he is no longer affiliated with the website or benefits financially from site operations, he still remains a professional in the clinical research space and currently serves as a Clinical Affairs Manager at a medical device company.

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