What does a typical monitoring visit look like?
Senior Cra Interview Questions
233 senior cra interview questions shared by candidates
What is the most challenging aspect of monitoring?
What is a typical day as a monitor like for you
1. PI oversight -what are the responsibilities -resources available for conducting the research (time, space, subject population, funding); medical care of trial subjects; communications with the IRB/IEC; compliance with the protocol; investigational product accountability, use and storage; randomization procedures; informed consent of subjects; and trial records and reports. 2. Limited time for the visit...what would you cover. new enrollments, ICF, SAE, AE. 3. Unreported SAE...how would you handle...have the sight report at the visit the minimal requirements at least...patient#, drug, event description, reporter, source of info, study #/title, relatedness to study drug, also report event resolution and obtain discharge summary for pharmacovigilance; retrain site on reporting; have site report Prot viol to IRB, and CRA/team or site to report to Sponsor. 3. Typical monitoring visit and activities-before, during and after visit. 4. How to approach a difficult team member.
Tell me your experience working on a difficult study and why?
Please explain your experience in research?
STAR method of interviewing. EX: Describe a time when you had a difficult coordinator and how you dealt with this.
Tell me about how you dealt with a difficult site?
Why moving of company?
Tell me what you know about recist criteria.
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