Week 3: Structured Leadership at DelRicht
The leadership is quite structured because of the hierarchy for running clinical trials within and beyond the company. I am interning as a study coordinator, so I am on the delegation log for each study to perform different tasks. Each study has a study coordinator who owns the study, so the other study coordinators report to them with any questions. They are responsible for overseeing the source documentation and interacting with the monitors who check the source as well. The monitors do not work for the company and are sent by the sponsor to check on many sites at visits 4-6 weeks apart.
Work is directed by following standard procedures based on the protocol of each study. The protocol requires collection of certain data at each visit, so a checklist is made for each visit for the study coordinator to follow to make sure they have the information to put into the database to send to the sponsoring pharmaceutical company to do that data analysis to determine if their investigational product is having a positive effect on the patients. The guidelines are so strict that there is no room for self-directed decision making, but the management team is open to any suggestions for improving the way the protocol is followed, such as creating new checklists and cheat sheets to not miss anything from the protocol since it is so lengthy and complex.
There is trust that everyone is completing their work, but mostly there are checks from the study owner and site manager to make sure everything is done correctly. This relates to the punishments and incentives that the leadership controls. The checks from the leadership keep things running smoothly so it seems to be effective. I have mostly been in the training phase so I am curious how my opinion will evolve as I take on more responsibility and have more overhead checks on my work from the leadership.
You’ve done a good job describing the structured nature of the work. With such structure, you’d think ‘oh, it would be hard to mess up’ but as you indicated in your last post, the detail of the protocol is so significant, there is lots of room to mess up – right:) I will be curious to see how your opinion evolves as well. I’ll also be curious to learn – if you learn – how individuals involved in this work long term manage what might seem like monotonous work. Please don’t misunderstand me, this is exceptionally important work, but I would imagine for some – given the significant structure and absence of creative license – it would become tedious. So the nature of the work may be better suited for some versus others. As you talk with your colleagues, you might talk with them about this – about longevity with the work, how they stay engaged/excited, etc.