clinical research coordinator

Note to File – Ep 5 / A Rising Tide Lifts all Ships

Clinical research sites can tend to be very tight-lipped. They don’t always like sharing a great deal of information with other sites.

While this is somewhat understandable given the competitive nature of securing trials, I want to encourage more sites to be transparent and add value in their relationships with other clinical research professionals.

At the end of the day, the more we share, the better off we all are.

Note to File - Ep 4 / CRAzy Train

Scan a document. Update a query for the 6th time. I even once had a CRA ask me to reorganize 25 patient binders to her liking – and I did it! I’ve since grown a lot more discerning when it comes to CRA demands.

These are relatively small and inconsequential requests that we all begrudgingly comply with, but CRAs contribute a great deal to how studies are managed at the site-level. I’ve been asked to withdraw patients, revise AE descriptions and submit protocol deviations under questionable circumstances by more than one CRA.

While I always advise coordinators to maintain a friendly and professional relationship with your CRA, it is equally important to use your best judgement when receiving requests. If an auditor shows up at your door, you (and ultimately your PI) will be responsible for how patients and studies are being managed at your site.

All this being said, an overwhelming majority of CRAs are knowledgeable, helpful and great at what they do. I know many are overworked and underappreciated so please don’t consider this a critique of CRAs, but rather a reminder to use your best judgement and not simply do as you are told.