1. The landscape of clinicalresearch is rapidly changing, due in large part to technological advances. Differentiate between what you do as a CRAnow, in 2017, and what the role of a CRA will look like 10 years from now. The landscape of clinical research has definitelyevolved over the last several years. From paper source documents to electronicdata capture, paper charts to electronic medical records, on-site monitoring toremote monitoring, 100% source data verification to risk-based monitoring, theindustry is indeed rapidly changing. As a CRA, routine monitoring visits are aweekly occurrence.
While current trials require on-site monitoring visits,others now allow remote monitoring visits. I believe in 10 years, on-sitevisits will be less frequent with remote monitoring taking precedence andrisk-based monitoring becoming the norm. In an age where technology is sharedso easily and frequently, I believe systems will be linked to “talk to eachother”; the Electronic Data Capture system will be able to talk to the ElectronicMedical Record system and the Clinical Trial Management System to the Trial MasterFile system, etc. This will result in sites and CRA’s having more fluidcommunication which in turn will increase productivity and provide moreaccurate data. 2. We all know that (once a CRA has verifiedappropriate consent has been obtained), a CRA verifies a subject’s medicalrecords adhere to ALCOA-C principles when cross-referencing the accuracy of CRFdata compared to medical records. AfterSource Document Verification (SDV), what do you feel is the most important roleof the CRA, and why? A CRA wears many hats.
While monitoring, sourcedocument verification, is my main “job”, I feel that the second most importantrole of a CRA is the relationship that we have with a site. As a previouscoordinator, I can recall first hand experiences of how my relationship with myCRA helped or hindered my work. If I had a pushy and unfriendly CRA thatprovided unattainable expectations, I did not try to accommodate him/her asmuch as I did when I had a friendly, personable CRA that could empathize withmy workload. I try to use this experience in my role now as a CRA. I try tomaintain a friendly attitude while empathizing, but provide expected timelineswhile emphasizing that we are all a team. It is extremely important to maintaina good working relationship with a site and their staff. When a CRA,coordinator, pharmacist, data coordinator and PI have a good relationship,issues that arise are easily resolved in a timely fashion.
You are able toapproach them in a friendly manner and discuss the outstanding action items ordelayed data entry and they usually are prompt to respond to resolve theseissues. I try to think of the site, the study and myself as one big team. Forour team to be successful we all have to work together; for the study to besuccessful, we all have to work together.