When I started writing this article I tried to describe what a typical week in the life of a Clinical Research Associate (CRA) would be. After much deliberation and just a single paragraph later, I realised that (and any CRA will tell you this) there is no such thing as a typical week. If you are hoping for a straight 9 to 5 job, you are not going to find it here. The job of a CRA is a constantly changing list of priorities and your responsibility is to juggle them all and deliver successfully...
While one week could involve sorting through mountains of filing in the local office, the next could have you attending an investigators’ meeting in Rome or monitoring in Aberdeen, Dublin and Skegness (it is a small town on the east coast of England). Don’t get me wrong: this is what I love about my job. It is difficult to get bored as a CRA, because you don’t have the time. It all starts in your first few weeks of joining any company, when it feels like your head is going to explode with all the Standard Operating Procedures (SOPs) and company policies that you are required to read. However, your first week or two seems to be the only time that you don’t have an ever-expanding list of ‘to do’ items… but this will change!
Another variable that comes into play is what stage of the clinical trial you are working on, ie, start up (feasibility, pre-study visits/site initiation visits), routine monitoring, or site/ study close-outs. Sometimes you can be working on many different studies in various therapeutic areas, each at a different stage of its lifecycle.
So, while the few days described here are fictional, they are entirely realistic…
Sunday (not a misprint)
17:00 After spending a relaxing weekend with the family I drive up to Manchester and stay overnight so I can be fresh and wide awake for a full day of monitoring on Monday. This is not uncommon and sometimes you might need to fly to an investigator meeting anywhere in the world and be available on Monday morning.
Monday: Routine monitoring visit
07:45 Get down to breakfast. I don’t function well on an empty stomach!
08:30 Check out of the hotel and drive to the hospital. I cannot imagine life without sat-nav these days. I did use maps when I first started as a CRA and mainly had to rely on the kindness of locals to find my destination. However, you will find that people are not at their most generous at this time in the morning!
09:00 Meet the Study Coordinator (SC) and have a quick catch-up on the expectations for today. This site is always well organised: the Case Report Forms (CRFs) and source notes I requested in my letter are already set up in the monitoring room together with the site files. This feels like an alternate universe when compared to the site I visited last week…
09:15 I switch on my computer and take out the data query forms together with my list of follow-up items from the previous visit. I’m all fired up and ready to monitor!
09:45 Reviewed CRF queries raised at the last visit. Responses verified, signed off and pages collected for two patients. Make a note to ask SC about unanswered queries for patient 0905 and to check if there have been any new Serious Adverse Events (SAEs). Time to move on to the screening and eligibility data for the new patient.
11:45 Patient 0910:
- Consent form checked
- Previous medical history notes reviewed
- Inclusion criteria verified
- Exclusion criteria verified
- Concomitant medications and adverse events pages checked
- CRF entries for screening visit verified against source notes and completed pages collected
Make a note to ask SC and Principal Investigator (PI) about missing screening assessments (protocol violation!), lab reports not signed and data queries raised for this patient.
12:30 Reviewed follow-up visits for two patients that have been taken off study. CRF entries verified and pages collected. I have a quick half an hour for lunch. Remember to get to the pharmacy at 13:00.
13:00 Refuelled, refreshed and ready for pharmacy.
13:20 Pharmacy folder checked and missing documents identified at the last visit were added.
13:50 Completed pill counts for returns collected since the last visit. Checked the total study drug supply against total pills dispensed and totals received. All totals correspond with receipt and dispensing logs, which is always a relief! Received an email 2 weeks ago about a minor temperature deviation, however, had confirmation from sponsor that drug was still fine to use. Need to confirm if deviations were correctly reported and if any further occurrences were observed. Make a note to confirm with pharmacist that air conditioner has been serviced since then and about documentation of this deviation in a note to file.
14:00 Temperature logs for storage areas checked since last visit and all looks fine except for the one deviation previously reported. Signatures on dispensing log correspond with delegation log.
14:10 A quick chat with pharmacist about what was carried out at this visit and the outstanding actions.
14:15 Back in the clinical trials office. More Source Data Verification (SDV ) to be done. Need to get the PI to sign a few CRF pages when we meet at 15:30.
15:30 Study coordinator and I are at PI’s office. The PI is late getting back from clinic, so I have few minutes to discuss ongoing items with the SC.
15:45 PI arrives but has another meeting at 16:00. I ask him to please review and sign the CRF pages and highlighted the protocol deviations identified for the patients that I reviewed today. Although these were considered minor, the PI has agreed to retrain the physician involved. PI mentions that he is getting a new physician allocated to the study. Reminder to get CV, financial disclosure forms and updated FDA-1572 signed. The meeting is over before it began. Thank PI for his time and remind him that all other follow-up items will be mentioned in the follow-up letter.
16:05 SC has time to review and resolve data queries. Queries signed off and CRF pages collected where possible. SC agrees to discuss Adverse Event (AE) queries with the PI prior to the next visit. Make a note to discuss a few issues with Data management on how they want the data recorded to prevent any data clarification forms (DCFs). That reminds me: there were two DCFs pending since the last visit. Need to check with the SC if these have been resolved.
16:45 Time for review of the site files. Checklist out, files open, pen, punch and stapler… ready, steady, go! First, add missing documents from the last visit. Noticed a new signature on the CRF: need to check this against the signature and delegation log. Sign visit log, check sections 8.0 – 12.0 and list all missing documents for filing at the next visit.
17:15 Meet with SC to discuss items reviewed at this visit and outstanding items for follow up. Discuss availability for next visit in 6 weeks time.
17:30 Hope the traffic is not too heavy heading back.
Tuesday: Office
08:30 Haven’t been in the office since last Wednesday. Hope my email inbox has not exploded. Switch on computer, grab a coffee, check calendar, and ‘to do’ list for the week. Check voicemails and faxes.
08:45 Received a voicemail from one of the sites that I contacted last week regarding feasibility for a new study. Need to send through the study synopsis and survey. Also need to follow up with the other five sites that were contacted.
09:00 Complete last weeks timesheet and start reviewing emails. Delete, delete, forward, file in study email folder, delete, reply, reply and file in study folder, add to calendar, delete, reply and add a reminder for next week, file in study email folder… a few hundred more to go…
10:00 Dial into EU-wide CRA teleconference for my newest study, which is in start-up. I met most of these CRAs at the investigator meeting last month in Lisbon. It was great to match up the voices to the faces.
11:00 Meeting over. Need to follow up with the UK sites for this study to collect their outstanding essential documents prior to site initiation visits (SIVs). I have a chat with the study start up team to check what is missing for these sites. Called the study coordinators and R&D departments to arrange for the outstanding contracts and documents to be signed and forwarded to me ASAP.
12:00 More emails to read: reply, delete, file, forward, add reminders…
12:45 Lunch at my computer: need to book a hotel and flights for a site initiation visit in Dundee in a few weeks.
13:15 Continue with last week’s visit report.
13:20 Call received from a site regarding a potential patient’s eligibility for the study. Checked protocol but need to discuss a few questions regarding this patient’s medical history with the Medical Monitor. Message left for the Medical Monitor and back-up email sent.
13:45 Back to last week’s visit report.
14:45 Call received from one of my Project Managers regarding responses to findings at a site audited last month. Need to follow up with the PI and study coordinator and reply by next Monday.
15:00 Response received from the Medical Monitor regarding the patient query I forwarded earlier. As suspected, the patient is not eligible. I forward the response to the PI and study coordinator and call the site to check whether they agree.
15:20 Finalise last week’s visit report. Complete CRF tracker and courier CRF pages to data management group in South Africa. Draw up follow-up letter to PI and thank site staff for a productive visit. Submit visit report to PM for approval. Submit expenses to finance.
16:20 Start report for yesterday’s visit. Email data managers with the CRF completion queries that were raised at this visit. Remember to email the SC with copies of the financial disclosure form and updated FDA-1572 with details of the new physician.
17:00 Courier more CRF pages to another data management group.
17:25 Received a call from my ‘better half ’ reminding me that we’ve got an appointment this evening so I have to leave work on time. Can’t argue with that, since I was late the previous two times. I have to leave in the next 5 minutes.
17:45 Run out of the office!
Wednesday: Office
08:30 Coffee and emails for breakfast.
09:00 Received responses from two more sites regarding the feasibility study. Forward documents and remind them that I need a response in the next week.
09:15 Continue with Monday’s visit report.
09:30 Call received from the pharmacy department at one of my sites. They ordered additional drug supplies 2 weeks ago but have not received any shipments to date and are worried that they may not have enough for a patient visit next Monday. I call the company responsible for drug shipments to check if they received the order. Unfortunately, they haven’t so I forward an order on the site’s behalf to prevent any further delays. The order has been received, the shipment will go out tomorrow and the site will receive more study drug on Friday. Make a note to check how site submitted the order and why it wasn’t received by the drug supply company.
10:15 Continue with Monday’s visit report.
10:45 Need to finish preparing for a progress meeting with my manager at 11:00. Make a note of what objectives I have completed since the previous meeting and what I aim to complete in the next 2 months.
11:00 Meeting with my line manager to discuss progress with objectives set at the beginning of the year. We come up with a plan of action for how I can achieve my development goals. Need to discuss some of these with my Project Manager to ensure that they tie in with my project-specific goals.
11:45 Make my bi-weekly calls to study sites that are having trouble recruiting patients. Need to check with these sites what issues are preventing them from recruiting and how we can work around this. Make sure these conversations are documented, because “If it’s not documented it didn’t happen!”
12:30 Have lunch with some of the guys in the canteen for a change. Topic of discussion today: how much we hate traffic and roundabouts. Listened to a funny story about a fight between a CRA and a spider in the car while in peak traffic, and the insurance claim that resulted.
13:10 Back to reality and more emails.
13:30 Finalise my visit report. Write follow-up letter to PI summarising items reviewed and issues for follow-up. Submit visit report to lead CRA for approval.
14:00 Read the latest corporate newsletter.
14:15 Catch up on new and updated SOPs to read. Training records updated.
15:00 Received a call from one of my sites regarding a study patient that passed away yesterday after being admitted to hospital. They were notified by the hospital this morning. Reminded site to submit a serious adverse event report to the drug safety team immediately and to contact me if they need any help with this. Discussed the minimum requirements for submitting an SAE report with the SC. Emailed the drug safety team to notify them of the SAE and to let them know that the report is on its way. It’s always sad to hear about a patient dying but this is when I am reminded of how my job fits into the whole scheme of things and how all the data and documents I review and collect may one day help someone else cope better with, or even overcome, their illnesses.
15:30 Prepare for an extended visit over the next 2 days at a site in London. The sponsor approved a 2-day visit due to an upcoming data management timeline. Print out missing documents for the site file, latest correspondence with the site, a copy of the confirmation letter sent to the PI, the previous visit report, follow up letter listing outstanding items and a list of outstanding CRF pages and DCFs.
17:00 Listen to a pre-recorded training session that I missed on Friday while replying to a few emails, before heading off for the next 2 days…
And so on…
And so it goes on, the next 2 days will involve more drug accountability, reviewing temperature logs, site files, more CRFs, queries, DCFs and meetings with site staff to resolve issues. It may seem that this could become routine after a while; however, I find that every study, every site and every visit is a new experience. New issues are identified and new ways to resolve them become evident. I’m reminded of a conversation that I had with a few colleagues recently about how you need to be a ‘jack-of-all-trades’ to be a successful CRA. You need to be a bit of a salesperson when you are setting up the study to convince investigators that your study is more interesting than a half a dozen other similar trials competing for the same patient population. You also need to be a trainer and coach to ensure that site staff are adequately informed about the protocol, study procedures and applicable regulations and remain suitably motivated during the course of the trial to keep up the recruitment figures so that the trial does not go on forever. Being a detective is the interesting part, although it can also be frustrating when you’re trying to figure out what has taken place with only limited documentation as evidence. At times you will also need to be a psychologist as you will deal with people from all walks of life and a variety of personalities ranging from a stressed out site data manager that has recently started out in clinical research to an extremely busy Professor who has been conducting trials “since before you were born”.
In addition, the field of clinical research is always evolving due to updated regulations and new ideas for improving the drug development process. Some people may consider these variables a deterrent when choosing a profession however, they are exactly what I need to keep me interested in a progressive career in clinical research.
