Although there are no exact rules, general educational requirements 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. Advanced degree is not required, but can be helpful for career progression.
CRAs perform variety of functions relating to clinical trial. As different functions require different skill sets, below are some skills that can be helpful in a CRA’s job performance:
- 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.
- 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.
- Attention to details. 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.
- 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.
- 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.
- 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.
- Knowledge of good clinical practice (GCP) and 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.
Photo credit: Neckarsulm Education Center, by Detlef Schobert, flickr
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