CRA Prep Exam Screen Questions & Answers 2024/2025
What Therapeutic areas and phases have you worked in? - ANSWERSCNS first in human
Oncology: phase 2 & 3
What studies have you been dedicated to? - ANSWERSI have worked on Alzheimer's studies phase I and breast cancer as well as colon canc...
What Therapeutic areas and phases have you worked in? - ANSWERSCNS first in human
Oncology: phase 2 & 3
What studies have you been dedicated to? - ANSWERSI have worked on Alzheimer's studies phase I and
breast cancer as well as colon cancer
Tell me a little bit about the studies you are working on? - ANSWERSWell, I am working on a phase I
study on Alzheimer's. it's a double blinded study on patients who current method of treatment is not
working. The studies uses a lot of rating scales like BPRS (brief psychiatric rating scale), and Positive and
negative syndrome scale.
Tell me about some of your current sites - ANSWERSWell I am working with UCLA in LA, UT Southwestern
in Dallas,
What is the highest number of protocols you have worked on? - ANSWERSMy highest number is four.
Tell me about one of the most difficult institutes you have worked with? - ANSWERSMD Anderson. It was
difficult because they give there CRAs a really hard time when it comes to scheduling visits. Also they
hire a lot of newbies in the research industry which leads to a of errors.
Have you worked on an oncology study? - ANSWERSyes
What clinical trial management systems do you use (CTMS)? - ANSWERSCeebo, Medidata Rave CTMS,
What EDC systems do you have experience with? - ANSWERSMedidata Rave, Inform, Omnicomm, and
Datalabs
, What experience do you have with TMFs? - ANSWERSI use the trial master file to run TMF reports that
will show outstanding documents that need to be collected from the site. Also CRAs are responsible for
uploading all there reports, Follow-up letters, and confirmation letters in to the TMF system using a TMF
naming convention.
What is the submission timeline of trip reports? - ANSWERSThe initial trip report is due in 5 business
days and the final trip report is due in 5 business days.
What phases of studies have you worked on? - ANSWERSI have worked on phases 1, 2, and 3.
How many PSSV have you done? - ANSWERS4
How many SIV have you done? - ANSWERS6-8
How many IMV have you done? - ANSWERS450-500
How many COVs have you performed? - ANSWERS2
What is your perception of a typical day as a CRA? - ANSWERSNo day is the same for a CRA. On a day
that a CRA designated for site visit, it is expected that the CRA should get to the site in time, well dressed
and ready for monitoring duties. At each interim visit, the CRA is expected to verify informed consent for
new patients, perform source document verification for all visits since the previous monitoring visit,
perform drug accountability, retrieve all updated essential and regulatory documents, retrain site
personnel on all areas of deficiencies. On the other hand, on a day that is not designated for site visit, a
CRA might be in-house writing up reports for previous visits, taking calls from sites and providing
answers to their question, replying emails from the site and sponsor as required, scheduling future site
visit, updating tracking documents for sites under his/her management.
What current metrics are you following: - ANSWERSWell in regards to reports, the draft is due in five
business days and the final is due in an additional five business days. Our follow-up letters are due in 10
business days. And expense reports are due in 15 business days.
What is the frequency of your site visits? - ANSWERSI visit my sites every 4-6 weeks.
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