Clinical Research Associates (CRAs) have several responsibilities. Source Data Review (SDR) and Source Data Verification (SDV) are the most common tasks that CRAs perform during a monitoring visit. SDV is basically conducted to compare Case Report Form (CRF) to source data. SDR is a review of source documentation to check quality of source, review protocol compliance and ensure the source documentation is adequate. Being able to do SDR is what makes you unique from other candidates to get a job as a CRA; if you are new to this industry and don’t have any SDR experience, here is how to prove that you will be able to complete this task:
Medical Terminology Knowledge
This is one of the basic knowledges to have, in order to perform SDR. A CRA should review several source documents including the labs, medical history, physical exams and adverse events. Moreover, the CRA reviews every single word in the progress note written by a physician. So, if you are looking to enter in a specific field of clinical research, make sure to have the relevant medical terminology knowledge. For example, if you are being interviewed for an oncology CRA, you need to have a good understanding of different cancer types. Therefore, during an interview if you hear the word “Lymphoma” you can ask a follow up question:
What type of lymphoma? Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Follicular Lymphoma (FL)?
Knowledge of the Disease/Condition
If you have completed a research project on a specific disease during your studies (graduate/undergraduate) you have a higher chance of getting a job as a CRA. For example, if you see a job description for a CRA position that needs someone with pain management experience, and you published an article on pain management in an animal model you must include the keyword “pain management” in your resume. In this example, the goal of including above keyword in your resume is to indicate you have a great understanding of the medications and common practices in pain management.
GCP knowledge
In order to work as a CRA you need a GCP certificate. Get your GCP certificate before applying for any clinical research position!! The GCP training mainly describes essential elements for monitoring a study and, also the responsibilities of investigators, sponsors, monitors, and IRBs in clinical trials.
Research Experience
In my previous article, I explained the importance of study protocols in clinical research. Research experience facilitates the understanding of basic concepts and aims of the protocol. Similar to other research studies, clinical trial protocols contain objectives, design, methodology, and statistical analysis of the study. Therefore, previous background in research activities can help you to monitor clinical studies as a CRA.