PPD Interview Questions and Answers, Exams of Medicine

Download PPD Interview Questions and Answers and more Exams Medicine in PDF only on Docsity! PPD Interview Questions and Answers How recent is your Infectious disease, vaccine and oncology experience? - correct answer My most recent experience in infection disease and vaccine is in 2017/2018. Oncology experience has been within the last two years as well Do you have experience performing remote visits? - correct answer Yes. The site provided secure EMR access with a unique user name and password which allowed me to review the data from my home office and compare it to the EDC to make sure the data matched. It counted as a full day on site and I completed a visit report just as I would have if I were physically on site. I was working at the beginning of Covid and some sites would send me redacted source documents and we would review things like ICF's by using FaceTime. Do you have experience with risk based monitoring? Please elaborate on your experience. - correct answer Yes. Really the monitoring frequency is pretty spread out. Instead of reviewing all of the data, there are key variable points that I would review specifically as far as SDV so it could be whatever the primary end points are for the study like vitals, sometimes dosing, things like that. But I'm still going to SDR everything to review and look for protocol deviations, if they're following GCP guidelines, review ICF and things like that. How were the SDV points determined? - correct answer In the monitoring plan, it outlines key variable points to SDV then I focus on SDR or source documents. I also worked on one project where we used a software that indicated which data points needed to be SDV'd at each site based on their risk score. Several factors went into determining this PPD Interview Questions and Answers computerized scored. But as a CRA I could override it if I felt it was in accurate. Walk me through the steps and task that you complete to prepare for an IMV? - correct answer OK. I'm going to send my confirmation letter to the site, i'm going to review my previous trip report and look for any outstanding action items but I'm usually following up with the site between visits and I can stay up-to-date on where those are. The same thing with the data. I'm reviewing data between visits so I would know if there is any missing data, open queries and anything that needs to be addressed. And then I would book my travel and go to the site and review all my notes from the previous visits. Have you ever had a CRA role where you have had to shared role with an in-house CRA? Did you enjoy that? - correct answer Yes. I enjoyed that working environment. It's good because sometimes when you have a lot on your plate, we are traveling and we're on an airplane and our site needs help with something, they can email that person and get the help that they need like uploading documents to the TMF and things like that. I feel like it's great. With your experience on a risk base monitoring trial, what was your experience like while working with an in-house CRA/data person? How did you all go about reviewing and discussing the data points? - correct answer It was good to work in a team atmosphere. Having an in-house CRA who reviews data as well and also handles some of the site management is very helpful. It is beneficial to have someone to calibrate with. PPD Interview Questions and Answers When air travel resumes, will you have any problem flying? - correct answer Not at all. I'm looking forward to flying again. What EDC, CTMS, and eTMF systems have you used? - correct answer EDC-RAVE, Bioclinica, Inform, QDR What is your proudest moment/accomplishment as a CRA,? - correct answer I would say that I am a really hard worker. I am a good communicator and a team player. I have been recognized for good performance from most of all the companies I have worked with. I have a really good reputation and I really pride myself in that. Are you familiar with dashboard? - correct answer No What is the difference between SDR and SDV? - correct answer SDV (source data verification) is looking at the data points and making sure they match what's in the EDC. SDR (source document review) making sure everything was done, quality of source (ALCOA-CCEA), and looking through the protocol compliance, patient safety etc. the term is used in risk based monitoring but as a good CRA we do this naturally in addition to SDV. How did I get started in the industry? - correct answer I begin in the industry as a coordinator. I think I started working at Kindle as a CRA. PPD Interview Questions and Answers Then INC acquired Kindle. In total, I worked with them for about 6 1/2 years. Most recently, I have contracted with various sponsors and CRO's