A Day in the Life of a CRA by Ann

Hi, I’m Ann and currently working on a contract as a lead CRA in an oncology trial. I am field-based working from home in Glasgow and am required to travel routinely to the site I am working with. CRA's often have very varied roles depending on the needs of the client, but this particular trial requires me to travel to Surrey approximately every 6 weeks for a 2 day visit. Here is an indication of what I do on my first day at site.

5am – 7.45am
Ensure that I have everything I require for my site visit (prepared the night before) including my laptop. Read trial related paperwork (e.g. updated protocols, Standard Operating Procedures (SOPs)) whilst waiting at the airport. Pick up a sandwich, in case I don’t have time to buy lunch at the site.

I arrive at site and speak with the research staff to arrange a suitable time for the research nurse to discuss trial issues; this can be either the first or second day of my visit.

As I tend to work from the meeting room, the staff usually prepare all the Investigator Site Files (ISF), case notes and any other trial related paperwork for me and have these laid out for my arrival. I unpack my laptop and A4 notepad and log on to the trial website I will be working from.

The first thing I always check whilst monitoring at site is whether there have been any serious adverse advents (SAEs). If so, I check that all necessary paperwork has been completed on time, as per ICH-GCP guidelines, and any follow up items that have been dealt with. Secondly, I check as to whether there have been any new patients consented. If so, I verify that all information has been entered correctly onto the form (dates, signatures etc) and cross check that the consent to the trial has been noted on the source documents (case notes).

Every third visit I am required to check that the ISF is up to date with all necessary paperwork, and file any new or updated documents. I also ensure that the information is in the correct section (as per ICH-GCP section 8). I make a list of any missing or out of date files which either the sponsor company or the site are required to provide. I then update the essential documents checklist to be sent to the sponsor on completion of my monitoring visit.

I start to verify information which has been put into the e-CRF against the source documents (case notes, lab reports etc) for all patients who have been consented and randomised onto the trial. I take notes for all the information which I look through to ensure I don’t miss anything out when meeting with the research staff.

Meet with the research nurse and/or site investigator to discuss progress to date with recruitment, any staff or resource changes at site and highlight any missing or incorrect data. The role of the CRA includes providing support and encouragement to the site staff and I enjoy having a good rapport with the staff.

Continue to verify information against the available source documents.

6pm - 8pm
Leave site for the day and get a taxi to the hotel. Unpack, have some dinner, turn on my laptop and check emails.

Finally I have a hot bath, as it’s been a long day, have a quick flick through the TV channels and it’s off to bed.

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