Clinical Trial Monitoring

Clinical Research Associate – A Day In My Life

Hi folks!!! This is Neha and I work with Clinexa Life Sciences as a Clinical Research Associate (CRA) . It’s strange but I have never tried to describe a routine day at my work place and during travel. So here I am, trying to give you a firsthand experience of my routine day and trying to put as much into words as possible. I hope that this will be helpful for you all aspiring clinical research associates!
Being a clinical research associate (CRA) is not only a lucrative and charismatic career option but also a highly demanding field. My job profile requires 60 to 70% of travel to clinical trial sites located in various cities across the length and breadth of India. I have always loved traveling and that makes my job even more fun and satisfying.
A clinical research associate is supposed to be good at multi-tasking. Only then will you be able to manage both your office related work as well as your travel appropriately (Not to mention your family too :-)) …
As a clinical research associate I am involved in managing all aspects of the clinical trial sites assigned to me and the activities associated with them, whether it is the preparation of documents for ethics committee submission, or reviewing the informed consent process and case report forms during monitoring, or even ensuring that the trial is being conducted as per the standard operating procedures (SOPs), guidelines and regulations. It is all about ensuring that the rights safety and well being of the patient’s who are enrolled in our clinical trials are being protected. This is why the job is very demanding. To be a good CRA you need to be well versed with the guidelines and regulations that need to be followed to conduct clinical trials. Not only those, you also need to ensure that you are aware about your study specific procedures, protocol, standard operating procedures, any recent changes in regulations etc.
Let me describe to you my previous visit to a site. The schedule and the process I follow is more or less the same for all of my travels.

The jam packed schedule glides as…

Morning– It starts in the wee hours getting ready for my site visit. Before leaving I affirm my checklist, prepared last night; everything related to the study that would be required during my visit, including my laptop are in place. I left for the airport at around 6:00 am as my flight was scheduled for 7:30 am. I grabbed a sandwich at the airport and after pushing my way through a mad mad crowd finally managed to board the plane just in the nick of time. It was a two hour flight so I pulled out a novel I was reading then to resume where I had left off. My efforts to read it were in vain as I dozed off to wander in the magical kingdom of my dreams.
9:30 am: – My plane landed and I took a cab straight to the site. I called few of my colleagues and checked for any recent update of the trial. I also confirmed some actionables that were decided in our last meet.
10:00 am: – The filmi (slang for someone influenced too much by movies) speedy cab driver who made me recall Rajnikant dodged the cab through the messy traffic in Rajnikant style and I finally managed got to reach the site on scheduled time, that too in one piece! I was greeted by the site manager who was also the study coordinator for my study and we proceeded towards the study room to start the day. The study coordinator had prepared all the investigator site files (ISF), case report forms, source notes and other trial related paperwork for me and I started my work by signing the site visit log. Different clinical research associates have different monitoring styles however I start my day with taking a look at the investigator site files. This is how I started that day too. A few documents here and there were missing in the site file which we were later able to locate and file in the required section. Next I started with my source data verification process which is to verify all data that the site filled in the case report form is matching with supporting source documents. This process also allows me to check for any serious adverse events that may have occurred at the site which may not have been reported by the site staff.
1:00 pm:– By lunch time I was almost half way through my source data verification process and was already feeling hungry. I then proceeded for lunch with the site coordinator to the hospital canteen. During the lunch we had a casual discussion regarding my meeting with the Investigator which was scheduled for later during the day, and about the observations that I made so far while checking the documents. I also thanked her for completing the action items that I had suggested during my previous visit.
1:30 pm:– I resumed by source data verification process, and generated a few queries for some sections where the data in the case report forms (CRF) was inconsistent with the data in the source documents. Next I performed drug accountability activities i.e. checked for shipments received from my last visit at the site as well as the current amount of unused drug on hand, used drugs returned by subjects and the earliest expiration dates. I checked for drug storage temperature logs to ensure the temperature of the study drugs had been maintained as per the requirement.
Some of the laboratory kits were about to expire and I had to ask the study coordinator to discontinue the use of those kits.
4:00 pm:– As per the pre-scheduled appointment with the Principal Investigator, I met him and discussed the trial related queries that I had come across while reviewing the CRFs and source notes. I took his valuable inputs on the trial related activities and difficulties they had faced during the recruitment of patients. I also appreciated the work performed and quality of documentation maintained by the CRC.
4:30 pm:– After the meeting I came back to the study room along with the CRC to finish off some pending work. Throughout my day I made notes in my diary regarding the activities that I performed, observations that I had made and the actionables that I suggested the site. I took out my monitoring visit checklist to ensure that I had indeed completed all things that I was supposed to. I enquired from the site staff for any outstanding questions or concerns and thanked the coordinators for their hard work on the trial.
05:30 pm:– I bid my farewell to the staff members and called for a cab to the airport. I had telechecked-in for my flight back home scheduled at 8:00 pm. It had been a long and tiring day and I stopped on my way to the airport to have a nice cup of tea and snacks at a famous cafe in the city. Finally, I reached home close to midnight and as I closed my eyes before going to sleep I felt proud as I had played a small part in helping a potential new treatment get to the market faster which would be of help to millions of patients.
Next Day:– I got to office only to see the loads of emails that I had to reply to and the number of things I had to follow up. I somehow managed to get some time during the day to submit my monitoring visit and the expense report to my study manager!!!
This was just one day of my life as a CRA and I know every day is not the same. It brings new challenges and learning’s; and every day is so different and unique. Come what may, at the end of the day, I feel relaxed and satisfied as the work I do is meaningful and aims at making a difference in people’s lives.

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