03 Jan Testimonials: A typical CRA day, from MZ-Seminario
Susan has been working as a CRA at a pharmaceutical company for 18 months. She is a medical biologist, lives in Utrecht a city in the Netherlands, and is on a Contract Placement assignment.
Here is a day in the life of Susan. It’s Monday morning, the beginning of a new week…
6.15: Up early, because I have a monitoring visit in Maastricht to perform today. With a bit of luck, I will be in the hospital by 9.30. I prepared for this monitoring visit on Thursday because on Friday I was on a monitoring visit in The Hague and Rotterdam.
7.25: Finally out of the house. I took the time to go through my things to make sure I have everything. I took out the paperwork from my visits on Friday, that way I don’t have to carry everything around.
8.30: While in the car, I call a few of my colleagues. Last Thursday we had a trial team meeting and I want to confirm some actions which we decided on. Of course I also tell them about my wonderful weekend and have a good laugh with one of them. I also call my Clinical Team Manager as a week ago we had a team meeting with all the other Contract Placement employees. I wanted to tell her that I already used some of the communication skills we practiced during that meeting. I thought it would be good to let her know.
9.55: A bit later than planned, I meet up with the Clinical Research Coordinator. She works at the poli clinic and coordinates the study on the investigator side. Today I will have a meeting with the investigator to discuss the results of the study. After I have gone through the basic administrative files, I start to perform Source Data Verification (SDV). That means that I compare the data in the patient files with the Case Report Forms (CRF), to make sure that they are the same. That is a task I must concentrate on.
12.00: I’ve gotten quite far with the SDV and am preparing for the meeting with the Investigator. I have written down my questions from some of the CRF’s and have organised all the files so that we can have the meeting in a swift and efficient manner. I go to lunch with the ladies from the poli clinic, always nice here in Maastricht.
13.00: After lunch I go to meet with the Investigator. She has exactly half an hour because her rounds start at 13.30. Because I have everything at hand and organized, we get through quite a lot. A half hour turns out being just a bit short. She says that she will go though the rest herself and in 4 weeks time we can discuss it .
That fits perfectly in my planning. This site has such a steady and high recruitment rate that I must be here every 4 weeks. I stay to chat with everyone, but must get a move on to get the rest of my activities finished today.
14.00: Once at the hospital pharmacy, I perform Drug Accountability. That is to check the Investigation Product (Drug or Device) from both the medication in storage against the medication which was brought back by patients. This is also an activity which must be performed accurately and with my full concentration and it takes me about an hour to complete it. Thank goodness I did not find any discrepancies! The papers are signed and filed and I make an appointment for 4 weeks time.
15.00: In the Cardiology ward in the hospital is where the patients who are participating in our study are being treated. The nurses on this ward are aware of the study and all the extra procedures which must be performed on these patients.
I am looking for the head nurse so that I can invite her and her team for our ‘Research meeting’ that we are organizing in the next few weeks. During this meeting we will present the progress of the study and any new procedures which will be introduced. It is imperative that the nurse is there!
I cannot find the Head Nurse, but manage to speak with the nurse who was present at the initiation of the trial. I give her the invitation and explain the importance of the meeting. She says that she will take it to their next meeting and will let me know who will be joining. She also asks if I have time for a cup of tea? Of course!
15.45: I make a few notes before I leave. I look up a few things in my paperwork about other sites so that I can make a few useful phone calls while in the car. At 16.00 I leave and after making the calls I put on the radio.
17.50: Even though it was quite busy on the road, I’m back at home quite quickly. I organise my paperwork and put the things I’ll need tomorrow in my trolley bag. Tomorrow I have half a day at the office. A great time to write my reports from the last monitoring visits. Tomorrow afternoon I have a training for a new study. I’m excited about the training and the prospect of working in a new team and a new indication area.
18.15: Enough for today. I decide that after such a long and intensive day as today, I can go home a bit earlier tomorrow.