Clinical Research Associate (CRA) Interview Questions and Answers, Exams of Nursing

Download Clinical Research Associate (CRA) Interview Questions and Answers and more Exams Nursing in PDF only on Docsity! CRA Interview Questions and Answers. What is a 1572? - Correct Answers It provides the sponsor with information about the investigator's qualifications and the site that enables the sponsor to establish and document that the investigator is qualified and the site is an appropriate location to conduct the study To inform the investigator of his/her obligations and obtain the investigator's commitment to follow FDA regulations. What is required in an informed consent? - Correct Answers 1. Description of Clinical Investigation 2. Risks and Discomforts 3. Benefits 4. Alternative Procedures or Treatments 5. Confidentiality 6. Compensation and Medical Treatment in Event of Injury 7. Contacts 8. Voluntary Participation How do you remain organized? - Correct Answers For each study I create a step by step approach by which I will complete the tasks accordingly. I will create a list of tasks in accordance with their urgency. I handle the tracking of new IRB document with a red pen. At the site, we would photo copy new consents in different colored paper. Tell me about a time when an unexpected assignment required you to set aside your planned responsibilities. How did you handle it? - Correct Answers I would first analyze between the responsibilities I currently have and the unexpected assignment as to which is more urgent. If the unexpected assignment was not as urgent as the task at hand, I would notify whomever is requesting the assignment as to a timeline in which I will complete the task. How would you handle a coordinator that was not getting the work completed in a timely manner? - Correct Answers I would email the coordinator reminding he or she about the task at hand. I would then call the coordinator to ensure they have received the instructions. I would send a follow up email with the PI cc'ed. If the coordinator was still not compliant, I would send another email cc'ing the project manager. Why do you want to work for IQVIA? Why did you choose to apply at IQVIA? - Correct Answers - Patient advocacy - Best Multinational Workplace - 401(k) match up to 3% of your base salary and then 3% at 50% - Competitive 'per diem' strategy -CRA training Program - Regulation, and structure -Tuition reimbursement -Oncology experience What are your strengths and weaknesses? - Correct Answers Experience proficient in Microsoft word, excel and outlook. Problem solver. Detailed oriented, prioritizing tasks, analyzing a situation, complete tasks within a timely manner. Get tasks completed right away, hard working, flexible, adaptable, team player, Weakness: I'm anal when it comes to drug accountability. HR discussion Tell me about yourself which is not in resume. - Correct Answers Why do you want to become a CRA? - Correct Answers What salary do you prefer to receive? - Correct Answers 80,000k the least What databases do you know? - Correct Answers -OpenClinica -BioClinica (CTMS -SharePoint) -eTMF (Trial Interactive) and PhlexEview -DM Net Tell me how you would react if a CRC would not give you a document or piece of information. - Correct Answers First I will try to get it from CRC and if it doesn't work then I will approach to PI and ask him to get the document by explaining the importance of document and consequences if it is not provided. by simple therapeutic measures; moderate experiences may cause some interference with functioning · Severe: Events interrupt the participant's normal daily activities and generally require systemic drug therapy or other treatment; they are usually incapacitating Severity is not synonymous with seriousness. A severe rash is not likely to be an SAE. Likewise, a severe headache is not necessarily an SAE. However, mild chest pain may result in a day's hospitalization and thus is an SAE. Expected AE - Correct Answers Event is known to be associated with the intervention or condition under study. Unexpected SAE - Correct Answers Nature or severity of the event is not consistent with information about the condition under study or intervention in the protocol, consent form, product brochure, or investigator brochure. AE Relatedness - Correct Answers · Definitely Related: The adverse event is clearly related to the investigational agent/procedure - i.e. an event that follows a reasonable temporal sequence from administration of the study intervention, follows a known or expected response pattern to the suspected intervention, that is confirmed by improvement on stopping and reappearance of the event on repeated exposure and that could not be reasonably explained by the known characteristics of the subject's clinical state. · Possibly Related: An adverse event that follows a reasonable temporal sequence from administration of the study intervention follows a known or expected response pattern to the suspected intervention, but that could readily have been produced by a number of other factors. · Not Related: The adverse event is clearly not related to the investigational agent/procedure - i.e. another cause of the event is most plausible; and/or a clinically plausible temporal sequence is inconsistent with the onset of the event and the study intervention and/or a causal relationship is considered biologically implausible. Describe a situation in which you made an error. What happened and what did you do about it? - Correct Answers Zambia- List of SOPs. How would you handle a coordinator that was not getting the work completed in a timely manner. - Correct Answers -Help the coordinator find solutions to the barriers of him/her completing the work on time. -I will identify her difficulties , If she has a lot to do due to high enrollment, I will escalate to the PI to have an additional delegated assistant coordinator to help her, if she has difficulties with the eCRF and IVRS and IWRS, I will retrain her, I will also retrain her on the protocol, especially in regard to dosing, subject visit windows as specified by the protocol What are some regulatory documents required to start a clinical trial. - Correct Answers 1572, FDFs, Protocol Training for PI, SC and Pharmacists, Protocol Approval Explain the Regulatory Affairs Process - Correct Answers What is the meaning of Ethical (proper definition & not as per google) - Correct Answers Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. What tools are used by clinical research team? - Correct Answers Checklist (Inclusion/Exclusion Criteria, Consenting, Protocol, SAE logs, visit logs, protocol deviations, EDCs, Regulatory Binders, etc. ) What are the Clinical Research guidelines? - Correct Answers Define an SAE - Correct Answers Any adverse event that: · Results in death · Is life threatening, or places the participant at immediate risk of death from the event as it occurred · Requires or prolongs hospitalization · Causes persistent or significant disability or incapacity · Results in congenital anomalies or birth defects · Is another condition which investigators judge to represent significant hazards Must be reported to Sponsor within 24 hours- subject id, time and date, cause Adverse Event (AE) - Correct Answers Any untoward or unfavorable medical occurrence in a human study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants' involvement in the research, whether or not considered related to participation in the research. All AEs are collected on an Adverse Event Form, either in paper or electronic format. A sample AE Form is shown in Adverse Event Form. All AEs experienced by the participant during the time frame specified in the protocol (e.g., from the start of intervention through the end of the study) are to be reported, as outlined in the protocol. What are the roles of a CRA while working from home? - Correct Answers Which tasks do you complete at a site first if the following are occurring? - Correct Answers -Patient needs to be source verified and is now on C3D15 -You did not meet with the physician on your last visit and need to meet with them on this one - There are two newly registered patients beginning treatment the day you have arrived for your visit - You need to perform drug accountability? What is delegation of authority? - Correct Answers If a trial participant asks you to explain what a placebo is and why it may be used, what would your answer be? - Correct Answers I would explain to the participant that a placebo is an inactive pill, liquid or powder that has no treatment value. I will further explain that in a placebo controlled trial, some portion of the participants will receive placebo instead of an active drug or experimental treatment and that this is done to assess the experimental treatment's effectiveness and safety versus no treatment at all. I will tell the participant that a placebo is a liquid, powder, or pill that has no treatment value and that is used in clinical trials to help determine the difference between the active drug or experiment compared to no treatment at all. often conducted to determine whether finding cancer at early stage of symptoms decreases the chance of dying. These trials include people who do not have any signs of cancer. Diagnostic trials study could be used to identify cancer more accurately. They are sometimes part of another cancer clinical trial. The genetics component of the trial also focus on how genetic makeup can affect diagnosis, detection, or response to cancer treatment. There are Five phases of clinical Trials: - Correct Answers Pre-clinical: animal tests and In vitro (test tube), to determine dosing and any other potential risks to administration in the human beings. Phase One: The determination of safe doses of a new drug by trials on healthy human volunteers and the drug's effect on the body (pharmacodynamics) and the body's effect on the drug (pharmokinetics). Often performed by CROs (Contract Research Organisations) or in large teaching hospitals. Phase Two: Treatment or the experimental drug is given to a large group of people (100-300) to see that the drug is effective or not for that treatment. Phase Three: Studies with large numbers of patients undertaken by GPs or in hospital. Comparing of the efficiency and side effects of the drug with existing placebos and treatments. Phase Four: Is performed after the product license has been granted by the regulatory authorities. Industry conducts large, long term epidemiological studies to assess optimal use and for the marketing strategy of the drug these are essential. Safety (pharmacovigilance) is monitored by post marketing surveillance studies. Why Statistical Analysis Plan (SAP) Is Important? - Correct Answers SAP is the document that contains detailed information regarding the statistical methods and study objectives to help in the production of the Clinical Study Report (CSR) including figures, summary tables, and subject data listings for Protocol. Documentation of the program variables and algorithms that will be used to generate summary statistics and statistical analysis are also contained in this. What is Case Report Tabulation (CRT)? - Correct Answers CRT's are sent to the FDA whenever a pharmaceutical company is submitting an NDA. Explain verification. - Correct Answers Verification ensures the accuracy of the final tables and the quality of SAS programs which generates the final tables. I selected the subset of the final summary tables for verification according to the instructions SOP and SAP. Tell About Domains/datasets You Have Used In Your Studies? - Correct Answers Medical History, ECG, Labs , Demog , Physical Exam, Adverse Events ,Vitals etc Give Examples Of Edit Ckecks You Made In Your Programs? - Correct Answers Demographic: Body mass index is below expected and Weight is outside expected range (check weight and height). DOB is greater than the Visit date or not. The Gender value is a valid one or invalid. Age is not within expected range. Adverse Event: Visit Start is before birthdate or Stop is before the start. Study medicine discontinued due to the adverse event but completed Labs: Result is within the normal range and also abnormal is not blank or the case can be 'N'Result is outside the normal range and also abnormal is blank. Vitals: Diastolic Blood pressure more than Systolic Blood Pressure Medical History: Visit date prior to Screen date Physical Physical exam is normal and also comment included Last Observation Carried Forward (LOCF) - Correct Answers Pharmaceutical companies spend several months to conduct longitudinal studies on human subject. It is unrealistic to expect patients to keep timely visit over such a long period of time. Despite all the efforts, patient data are not collected for some and these become missing values in a SAS data set later. For reporting, the most recent previously available value is substituted for each of the missing visits. LOCF doesn't mean the last SAS dataset observation which gets carried forward rather it means last non-missing value carried forward. It is the values of individual measures which are actually "observations" in this case. Also if there are multiple variables containing these values then they will be carried forward independently. Clinical Research Managers (CRM) - Correct Answers They supervise informed consent forms for clinical trials, case report forms and design and writing of protocols. CRM ensures that Case Report Forms are reviewed timely and submitted to the data management group. What Is a Clinical Trial? - Correct Answers Clinical trials, also known as clinical studies, test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. Potential treatments, however, must first be studied in laboratory animals to determine its safety before they can be tried in people. Treatments having acceptable safety profiles and showing the most promise in the animal model are then moved into clinical trials. Clinical trials are an integral part of new product discovery and development, and are required by all regulatory agencies (e.g. the Food and Drug Administration (FDA) in the United States), before a new product can be brought to the market. Why Participate In A Clinical Trial? - Correct Answers The decision to participate in a clinical trial is one that should be made by the patient and his/her loved ones working in close communication with the physician. Participants in clinical trials play a key role in drug development and discovery; clinical trials contribute to knowledge and progress in treating and preventing diseases. First and foremost participants can help others by contributing to medical knowledge and improving public health. Further, a participant does not need to be a patient diagnosed with a specific disease or health problem as some clinical trials, focusing on safety, will include healthy volunteers. Patients who take part in clinical trials may benefit from the treatments they receive. As part of a clinical trial, a patient will receive either the What Are The Phases Of Clinical Trials? - Correct Answers Clinical trials are conducted in a series of stages, called phases, each having specific goals. This process provides information about the treatment in a controlled process intended to also protect the participants. The number of participants in each phase of the trial may be based on the overall incidence of the condition being studied. Clinical trials are usually classified into one of four phases: Phase 1: Sometimes called dosing, pharmacokinetic, or clinical pharmacology studies, these trials test methods of administering the treatment (e.g. by mouth, injection, etc.) and how often, as well as the safety of the treatment. These trials usually involve a small number of healthy participants (20-80 healthy volunteers). Phase 2: These trials continue to test the safety of the treatment and evaluate how well the treatment is tolerated and how well it works. Phase II studies usually evaluate the treatment in a specific condition. These trials usually involve 100-300 patients. Phase 3: These trials compare the experimental treatment to the current standard of treatment for a specific condition, establishing both efficacy and adverse events. Participants are usually assigned to either receive the experimental treatment or the current standard. Phase III trials typically enroll large numbers of patients (1,000-3,000) and may be carried out at hospitals and doctors' offices nationwide. Phase 4: Post-marketing studies to gain a greater understanding of the treatment, including its risks, benefits, and optimal use. Depending on the purpose of these studies they may be small studies like the Phase I type OR may be even larger than a Phase III study. What Is A Prospective, Randomized, Double-blind, Controlled Clinical Trial? - Correct Answers A prospective, randomized, double-blind, controlled clinical trial is the most rigorous clinical trial design, and the one that regulatory agencies mandate must be conducted to demonstrate a medication's effectiveness and safety. In a new drug application, these studies represent the highest quality data regarding the drug and its actions, and form the basis for approval. In this study design, patients are carefully selected for participation and are randomly assigned to receive the experimental drug or a matching active drug or placebo. Neither the patient nor the treating physician knows which treatment was provided, thereby eliminating possible bias. Individual definitions of the study descriptions are: Prospective: Forward looking, beginning before the patient has started treatment. Randomized: Patients are randomly assigned to receive the experimental treatment or alternative (e.g. standard of care or placebo) Double-blind: Neither patients nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo or standard treatment. Controlled: One group of patients will be given an experimental drug or treatment, while a second group is given either a standard treatment for the illness or a placebo. What Are Side Effects And Adverse Reactions? - Correct Answers Side effects include any undesired actions or effects of a drug or treatment. Experimental drugs must be evaluated for both immediate and long-term side effects. Can A Participant Leave A Clinical Trial At Any Point? - Correct Answers A participant can leave a clinical trial at any time. The participant should let the research team know when withdrawing from the trial and the reasons for leaving the study. Who Sponsors A Clinical Trial? - Correct Answers Clinical trials can be sponsored or funded by a variety of organizations or individuals including physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to government agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), Human Health and Services (HHS), and the Department of Veteran's Affairs (VA). Are you familiar with what 'expanded access' means? - Correct Answers Expanded access is the term used to describe the means by which manufacturers make new drugs that are being investigated available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial. If you have experience working with patients who have been given expanded access, share some details, as appropriate. If you don't have personal experience, share your knowledge. I do have some knowledge about 'expanded access' although I have not worked directly with patients who have been giveThe 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. Are you familiar with what a protocol is with regard to clinical research? - Correct Answers A protocol is the plan that the clinical trial is based upon. It describes the details regarding what people may participate in the trial as well as tests, medications, and length of the study. Yes, I am familiar with the term 'protocol.' With regard to clinical trials, it is the guide or plan that describes how a trial is to be carried out. It lists what types of patients may participate, what tests or procedures need to be done, the medications, dosages, etc. that need to be monitored. If you had your choice of a research project to work with, what would you choose? - Correct Answers Research is such an exciting industry. If I had a choice, I would love to work on any project that has to do with cancer research. Cancer is a dreadful diagnosis and I would love to have some part in helping to find better ways to treat and hopefully cure it. I have always wanted to work in research, but I really don't know if I have a favorite or preferred area. Things change so quickly within our industry that I feel like any area I work in would be exciting. What's been the toughest criticism you received so far in your career? What did you do with it? - Correct Answers Can you tell us about a time you took initiative on a project or a task at work? - Correct Answers