I’m posting to let you know what kinds of questions you might expect to be asked during a CRA interview. Practice these in the shower, in front of the mirror, or with a friend so you are prepared!
Here are general questions that you will likely be asked with tips for answering shown in italics:
So here are the more role-specific questions:
Undoubtedly, the last question you will be asked is, “Do you have any questions for me or about our company?” And the answer is, Yes, you do! I know you will be nervous, but ask good questions and listen to the answers to the questions and try to get feedback during the interview so you know how you are doing. You may have been misunderstood during the interview or missed an opportunity to really sell yourself. Asking great questions will give you one last chance to show your best or address any concerns the interviewer has before you part or even in a follow-up letter or email. Here are some generic ones, but you have to ask something:
At this point, I want to mention that there are various interview styles. Being familiar with how (and why) questions might be asked will only help make you more prepared when it is time to come up with the answers. I am going to discuss a few interview styles below. The person conducting the interview may stick to just one style or have a mix of several – this is especially true when you are in a panel interview. Then it feels like you are in a firing range but just stay calm and try to engage the panel so you aren’t doing all the talking. After all, this is your opportunity to interview them, too, right? Anyway, here are a few interview styles you might encounter:
Behavioral – Everyone knows that past behavior is a very good indicator of future performance. This interview style will require you to answer in a manner that shows you are creative and quick on your feet. Sometimes the right answer is not as important as the delivery. Before you answer think hard about why they are asking this particular question and try to cite examples of past behaviors that are relevant to the job you are applying for and explain at the end how the skills and experience you are describing would be transferable in your new role. If they ask you about a past mistake or you describe something you did but would now do differently, say so and explain why. Nobody is perfect so showing that you learn from past experiences can only help you in the interview.
Situational/Scenario – If you have no idea what the right answer is, you can try stalling, asking the interviewer for help, or just qualifying your response. For example, “Honestly, I am thinking of a few possible answers for the question. On the one hand, I feel like this might be the right response, but on the other hand, I can see a scenario where this might be the right approach. Which are you looking for?” or “Well, I must admit that I haven’t ever been faced with this particular situation, but I imagine I would handle it as follows….” Here are some examples of situational questions:
Assertive – I personally find this style offensive. Any employer that utilizes these tactics is likely not one that I am very interested in working for. After all, if they are a jerk in the interview, what is it going to be like on a daily basis or when it is time to sign your expense reports, or partner to work on your performance goals, etc. In any case, an assertive interviewer will treat you really nastily or act very cold/aloof to see if you will get nervous or flustered. I find brevity is key in these types of interviews and if there are long periods of silence, just sit calmly and pretend like you are unaffected. Be careful not to be too defensive – it is usually a trap to see if you can keep your cool under pressure. They might say something catty like:
Structured – This interview is basically just like a test and you need to pass to make it to the next round. It is a typical style for CROs (where many different people perform new candidate interviews but then need to assess all applicants against the same standards) or for first-round interviewers. Essentially, the interviewer is looking for a specific answer, and once you say the magic word or list the 3 bullets they are looking for, they will move on to the next question. It is fine to ask how you are doing if you are feeling nervous along the way – they will probably find it endearing rather than count that against you (they probably suffered through the same type of interview when they were hired).
What is a clinical trial?
Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. ClinicalTrials.gov includes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.
What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant’s native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
What are side effects and adverse reactions?
Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.
How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants’ names will remain secret and will not be mentioned in these reports (See Confidentiality Regarding Trial Participants).
What should people consider before participating in a trial?
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.
Does a participant continue to work with a primary health care provider while in a trial?
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.
Can a participant leave a clinical trial after it has begun?
Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.
Where do the ideas for trials come from?
Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the experimental treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about an experimental treatment, its risks and how well it may or may not work.
Who sponsors clinical trials?
Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran’s Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors’ offices, or community clinics.
What is a protocol?
A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
What is a placebo?
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment’s effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or experimental treatment.
What is a control or control group?
A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.
What are the different types of clinical trials?
What are the phases of clinical trials?
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
What is “expanded access”?
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Most human use of investigational new drugs takes place in controlled clinical trials conducted to assess the safety and efficacy of new drugs. Data from these trials are used to determine whether a drug is safe and effective, and serve as the basis for the drug marketing application. Sometimes, patients do not qualify for these controlled trials because of other health problems, age, or other factors, or are otherwise unable to enroll in such trials (e.g., a patient may not live sufficiently close to a clinical trial site).
For patients who cannot participate in a clinical trial of an investigational drug, but have a serious disease or condition that may benefit from treatment with the drug,FDA regulations enable manufacturers of such drugs to provide those patients access to the drug under certain situations, known as “expanded access.” For example, the drug cannot expose patients to unreasonable risks given the severity of the disease to be treated and the patient does not have any other satisfactory therapeutic options (e.g., an approved drug that could be used to treat the patient’s disease or condition). The manufacturer must be willing to make the drug available for expanded access use. The primary intent of expanded access is to provide treatment for a patient’s disease or condition, rather than to collect data about the study drug.
Some investigational drugs are available for treatment use from pharmaceutical manufacturers through expanded access programs listed in ClinicalTrials.gov. If you or a loved one is interested in treatment with an investigational drug under an expanded access protocol listed in ClinicalTrials.gov, review the protocol eligibility criteria and inquire at the Contact Information number. If there is not an expanded access protocol listed in ClinicalTrials.gov, you or your health care provider may contact a manufacturer of an investigational drug directly to ask about expanded access programs.
1. Describe the phases of clinical trials?
Ans: These are the following four phases of the clinical trials:
Phase 1: Test a new drug or treatment to a small group of people (20-80) to evaluate its safety.
Phase 2: The experimental drug or treatment is given to a large group of people (100-300) to see that the drug is effective or not for that treatment.
Phase 3: The experimental drug or treatment is given to a large group of people (1000-3000) to see its effectiveness, monitor side effects and compare it to commonly used treatments.
Phase 4: The 4 phase study includes the post marketing studies including the drug’s risk, benefits etc.
2. Describe the validation procedure? How would you perform the validation for TLG as well as analysis data set?
Ans: Validation procedure is used to check the output of the SAS program generated by the source programmer. In this process validator write the program and generate the output. If this output is same as the output generated by the SAS programmer’s output then the program is considered to be valid. We can perform this validation for TLG by checking the output manually and for analysis data set it can be done using PROC COMPARE.
3. How would you perform the validation for the listing, which has 400 pages?
Ans: It is not possible to perform the validation for the listing having 400 pages manually. To do this, we convert the listing in data sets by using PROC RTF and then after that we can compare it by using PROC COMPARE.
4. Can you use PROC COMPARE to validate listings? Why?
Ans: Yes, we can use PROC COMPARE to validate the listing because if there are many entries (pages) in the listings then it is not possible to check them manually. So in this condition we use PROC COMPARE to validate the listings.
5. How would you generate tables, listings and graphs?
Ans: We can generate the listings by using the PROC REPORT. Similarly we can create the tables by using PROC FREQ, PROC MEANS, and PROC TRANSPOSE and PROC REPORT. We would generate graph, using proc Gplot etc.
6. How many tables can you create in a day?
Ans: Actually it depends on the complexity of the tables if there are same type of tables then, we can create 1-2-3 tables in a day.
7. What are all the PROCS have you used in your experience?
Ans: I have used many procedures like proc report, proc sort, proc format etc. I have used proc report to generate the list report, in this procedure I have used subjid as order variable and trt_grp, sbd, dbd as display variables.
8. Describe the data sets you have come across in your life?
Ans: I have worked with demographic, adverse event, laboratory, analysis and other data sets.
9. How would you submit the docs to FDA? Who will submit the docs?
Ans: We can submit the docs to FDA by e-submission. Docs can be submitted to FDA using define.pdf or define.Xml formats. In this doc we have the documentation about macros and program and E-records also. Statistician or project manager will submit this doc to FDA.
10. What are the docs do you submit to FDA?
Ans: We submit ISS and ISE documents to FDA.