CRA Interview prep - how to prepare for a CRA interview & common questions?

CRA Interview prep - how to prepare for a CRA interview & common questions?
Do not index
Do not index
Hello 👋, my clinical research wizards!
We've all been there - the CRA interview prep can be intimidating and sometimes even scary. It does get a little bit better with time and experience gained through your work in the field. However, the uneasy feeling of the unknown, what you will be asked, or whether you will respond correctly to scenarios, somehow always remains.
Since I launched The CRA Wizard Academy and started my consulting business, where I help people pursue a career in clinical trials, I realized that the most common questions I've been asked by friends and strangers are how to prepare for a CRA (or equivalent) interview, how to build their CV, or how to develop and scale their LinkedIn profile for better success with recruiters. So, I have decided to write an article about it.
If you need a clinical research career advice book a slot from here.
This article serves as a comprehensive guide to prepare one for a CRA interview. I understand that the process can be somehow intimidating, especially if this is your first CRA interview that you have finally managed to land. Therefore, I have provided some advice, Q&A examples, and scenarios that you may encounter throughout your career. And if you would like to read more about how to land a CRA interview, check out my previous article here.
Also, I understand that most of you don't have interviews every other day, and this article could be forgotten. So, make sure to save the article for later, or for whenever you need a recap.
I have provided answer examples below; however, I do encourage you to be as sincere as possible with your own answers! In my opinion, being straightforward and truthful is the best strategy for any interview and great communication practice in general! This leaves no room for guessing or interpretation and will save time and potential disappointment for both you and your potential employer.

Research the background and values of your desired company

This is your starting point. Begin by conducting research on the company, if you haven't already done so when applying for the position. Read about the company's pipeline to determine which therapeutic areas they focus on the most. If you have relevant experience in any of these areas, it's a good opportunity to mention it 😉.
notion image
You may also be asked about specific company values and how you understand them. Prepare to provide an example from your job where you followed one of the company's values.
Try to use an example that aligns with the values you have researched. Think about how you can implement it in a work-related situation that required strong problem-solving skills on your part.
In the example below, I have used the imaginary value "We put patients first" and incorporated it into an imaginary situation:
Here is an example for patient safety: There was a time when one of the subjects in one of my sites experienced a Serious Adverse Event, which led to myocardial infarction. The subject became unfit for the study due to an IMP-related SAE. However, the Sponsor insisted that the Principal Investigator change her mind about the subject's eligibility in the study, which could have compromised patient safety.
How did I handle it (keeping in mind the value)? I had a lengthy discussion with the Principal Investigator to fully understand her concerns. Afterwards, I discussed it with the medical monitors. We then had a conversation with the Sponsor's safety team. During the conversation, the safety team repeatedly insisted that the PI amend her assessment and continue the patient in the trial. I supported the investigator and helped her explain her reasoning. Additionally, I reminded the safety team that patient safety should always come first. Keeping the patient in the study would have put her overall well-being at risk, when the risks outweighed the benefits of the study drug. Therefore, we did not wish to compromise both patient safety and the overall study results in that manner.

Questions your interviewer may ask you

Next, there are always generic questions that are likely to be asked in any interview, not just limited to clinical trials. As simple as they seem, they are also the starting point for your conversation with the interviewer. They will set the tone and help establish a connection during the interview. These questions are essential, and it is best to anticipate them and already have prepared answers. This way, you can avoid thinking out loud during the interview and ensure that you present yourself in the best possible way. The better prepared you are, the less likely you are to say something out of context that could negatively impact your chances.
Here are some examples of such questions, along with the answers I would have provided. However, keep in mind that this will vary between different companies and may not always be applicable. As usual, there is no one-size-fits-all approach.

Q: Why do you want to work for company X?

Answer: Company X is a multinational pharmaceutical and/or biopharmaceutical company renowned for its contributions to the healthcare industry. Here are some key aspects for which X is known:
  1. Pharmaceutical Innovation: X is recognized for its dedication to research and development, resulting in the discovery and development of innovative drugs and treatments in various therapeutic areas.
  1. Global Presence: The company has a strong global presence, operating in multiple countries and collaborating with healthcare professionals, researchers, and organizations worldwide.
  1. Focus on Chronic Diseases: According to your pipeline, X is particularly known for its focus on chronic diseases, including cardiovascular diseases, respiratory conditions, oncology, rare diseases, and diabetes.
Taking that into consideration, I would like to be part of the team, as the company's reputation and presence strongly resonate with what I see as my purpose, and I would love to work in a similar-minded environment.

Q: Why are you interested in the CRA role?

Answer: The role of a CRA is highly responsible and dynamic. As a CRA, our job is to serve as the intermediary between the sponsor and the investigational site. We ensure that the clinical trial is conducted with the utmost standards of quality, safety, and compliance. Our monitoring activities play a vital role in maintaining data integrity and ensuring patient safety throughout the trial. Sometimes, we do handle unexpected challenges and put out fires. These aspects of the role motivate and drive me, and I look forward to career progression in the future.

Q: Why do you want to change companies?

Answer: Here is crucially important, to NOT TRASH YOUR PREVI0US EMPLOYER! Seriously, I mean it, I would have thought this is a no-brainer, however, you would be surprised by the amount of people failing interviews, because they have been disrespectful towards their ex boss.
Instead, I would advise you to explain your reasons calmly and respectfully. Try to be as sincere as possible, but also detach from any personal feelings you might have towards your previous company. Instead, focus on processes and what you would like to improve in the future. You could say something like: "I was presented with a fantastic opportunity, and I am delighted to have the chance to meet you and discuss this with you. Your company is a great place to work, and I am excited to be considered as a potential addition to your team.”

Job specific questions

Q: Describe a situation where a patient does not meet one or more of the inclusion/exclusion criteria – how would you handle this?

Answer: The main goal of clinical trials is to prove that a medication is safe and effective when used by the target population it was designed for. In general, if a subject does not meet an inclusion criteria, they are not eligible for the study. However, depending on the study specifics, this could be reviewed on case by case basis - lets say there is some wiggle room in the protocol e.g mentioned exceptions which could be confirmed by the medical monitor - in this situation it is always worth the try to review the particular case and unmet criteria with the Medical Monitor, as the values may come extremely close and again, depending on the study, the MM may be able to provide a waiver, considering the patient safety as a priority of course an the benefit outweighs the risk.

Q: How do you prepare for an RMV?

  1. Review Study Documents: Familiarize yourself with all study-related documents, including the protocol, investigator's brochure, study manual, and monitoring plan. Ensure you understand the study objectives, procedures, and requirements.
  1. Study Site Information: Gather detailed information about the site you'll be visiting, such as its location, contact details, and the names of the principal investigator and key site staff.
  1. Review Site Performance: Assess the site's performance and enrollment progress before the visit. Review the site’s enrolment plan. Check if there have been any outstanding issues or deviations that need to be addressed during the monitoring visit, or outstanding such form previous visits.
  1. Monitoring Visit Schedule: Coordinate with the site staff to establish a suitable date and time for the monitoring visit. Make sure all relevant personnel, including the investigator, sub-investigators, and study coordinator, are available during the visit. Bring comfortable shoes, just in case you have to chase the PI down the whole 😁.
  1. Prepare Monitoring Tools: Assemble all necessary monitoring tools, including the case report forms (CRFs), data validation checklists, and any study-specific monitoring worksheets.
  1. Data Management System: Ensure that you have access to the data management system or electronic data capture (EDC) platform to review study data remotely or on-site if applicable.
  1. Prepare Monitoring Plan: Develop a monitoring plan tailored to the specific study and site, outlining the areas to be assessed, data to be verified, and any specific focus points.
  1. Travel Arrangements: If the site is located away from your regular workplace, arrange travel and accommodation well in advance to ensure a timely arrival for the monitoring visit.
  1. Regulatory Documents: Check that all regulatory documents, such as ethics committee approvals, informed consent forms, and investigator CVs, are up-to-date and available for review. Check if there are any recent protocol amendments, ICF updates etc.
  1. Investigational Product: Ensure that the investigational product (IMP) is appropriately stored and accounted for at the site. Verify that there have been no issues with IP management and compliance.
  1. Checklist and Compliance: Prepare a monitoring visit checklist to ensure you cover all necessary aspects during the visit, including data verification, regulatory compliance, and adherence to the protocol.
  1. Communication: Inform the site staff about the upcoming monitoring visit and its purpose. Clarify any expectations and address any questions or concerns they may have.
  1. Coordinate with Sponsor: Communicate with the study sponsor to share the visit schedule and discuss any specific topics or areas of interest for the visit.
  1. Personal Readiness: Make sure you are well-prepared, organized, and have all necessary documentation and materials ready before heading to the site. Always bring a pen and sticky notes, you will thank me later.
  1. Additional Preparations: Depending on the study and site-specific requirements, you may need to prepare for specific aspects such as central lab result reviews, serious adverse event reconciliation, or protocol deviation investigations.

Q: How do you deal with a “difficult investigator”?

A: I once had an investigator who perceived me as too young and inexperienced and didn't take me seriously. From that point on, I had to strive for perfection - I couldn't be five minutes late for a meeting, I had to provide the right guidance each time, and I couldn't say "I don't know, I'll check and get back to you" (which is an absolutely valid response by the way) - I simply had to be perfect. I learned to adapt to his communication style and keep it professional.
Now, I am his favourite CRA, and he does not want to work with anyone else.
Throughout my career, I have experimented with different approaches to communicating with my site teams. I tried being extremely professional, keeping communication strictly official. I also tried being more friendly to build better trust with my teams. However, I discovered that there is no perfect recipe for building a good relationship with your site teams. It's more about adapting to their communication patterns and letting them take the lead.

Questions to ask your future employer:

Keep in mind that a job interview is a two-way street. You are not only being interviewed by your future employer, but you are also interviewing them. This is your chance to learn more about the company you want to work for and gain knowledge about clinical trials in general. This will help you imagine yourself in their team and ultimately, to make your final decision.
And even if the interview doesn't go well, the interviewer will likely provide feedback on where you went wrong, giving you an opportunity to improve in the future. So, don't hesitate to ask questions about anything that interests you.

Q: What would my daily responsibilities be?

It is crucial for you to know the specific tasks and duties you would have on a daily basis. Although I am now an experienced CRA, the responsibilities can vary between different CROs/Sponsors. Therefore, I always inquire about the details of the role I am being considered for. For example, I ask about the structure of the team, the phase/therapeutic area of the potential studies; extent of travel required, the deadlines for drafting and finalizing reports, and whether it is a single or multi-sponsor dedicated position. These questions can provide you with valuable information about the job you will be doing. For example, let’s say you are being told you will work predominantly on phase II studies. Phase II typically focus more on IMP safety profile, which involves a significant amount of safety procedures being placed for the subjects, collection and evaluation of PK samples, and frequent patient visits as outlined in the protocol. As a result, you can deduct that you will need to be more vigilant in identifying safety-related deviations, due to the complicity of the protocol, there will be more room for error; subject visits will be more frequent; you will travel more frequently for on-site visits, and have less time for reporting, e.g the deadlines for reporting will be tighter etc. Phase II studies are more reactive and require a high level of attention to detail.

Q: How would you describe the company culture? What makes you enjoy being part of the team/company?

The company culture is of utmost importance. It is preferable to work with bright, ambitious, and positive individuals, so the work culture matters greatly. Personally, I appreciate a forward-thinking and innovative environment where new ideas are welcomed. Therefore, I ask questions such as "how would you describe the company culture?" and "what value do your colleagues bring to your work?" In general, I am interested in knowing if there is room for introducing new ideas. So, make sure to identify which part of the company culture is important to you and inquire about the company's stance on that.

Q: Is the team based remote or at the office?

Last but not least, in todays’ world where everything is more and more thriving towards the digital and location independent, it is extremely important for me to have the option to work fully remote. I don't believe in the recently created "hybrid" work situationship, which involves something of the sort three days at the office and two days from home for most companies. Let me explain why. It has nothing to do with my productivity - I'm more or less equally productive, regardless of where I work from. I believe that the hybrid solution is not ideal, as it implies a lack of trust in the team's ability to work remotely. This raises the question of why you would hire people with questionable work ethics whom you have to micromanage for at least three days per week. Even if you comply with the rule, you may find that your colleagues have decided to work from home that day, making the whole idea of being at the office redundant.
Personally, I prefer to work from home, where I have a dedicated home office space (house 🐍 Slytherin here). I find it less distracting, as I'm not interrupted by anyone, furthermore, I don't waste time on coffee breaks or getting ready for work or commute. It's just a lot calmer, and I appreciate that.
notion image
That being said, I really admire my colleagues, and working at PSI CRO is an incredible experience, largely thanks to the company's transparent, relaxed, and easy-going culture. I genuinely enjoy my time in the office as it allows me to connect with my colleagues. However, personally, going to the office holds more of a social aspect for me. And the PSI CRO parties are absolutely fantastic! 😁 👌🏿
notion image
PSI CRO’s 28th birthday in November 2023.
Anyway, it is important to ask about the requirements related to remote work during your interview.

Final advice

Interviews are similar to first dates in many ways. So, it may sound like a cliche, but try to be the most authentic and sincere version of yourself while remaining professional. Don't try to pretend to be someone you're not just to impress and secure the job. Ultimately, you won't be able to keep up the facade forever and you'll end up in a place where you're not happy, doing a job that doesn't bring you fulfilment.
Good luck on your interview! I'm confident that you will do great! 👊
Finally, if you'd like additional preparation before your interview, feel free to book a slot with me here. We will go through all the details together, conduct a mock interview, and ensure that you are fully prepared for anything that comes your way on the path to your dream job!