CRA Flashcards
What is the role of a cra?
Patient safety, liaison sponsor clinical site, etc…
What would you do if you got to a site and they told you they didn’t have time for you?
First, clarify who “they” are. You can usually perform some tasks associated with the visit (e.g., regulatory binder review, some aspects of study drug reconciliation) even if primary personnel aren’t available. Determine the root cause of their unavailability. Discuss the issue with the Principal Investigator and the (site’s) site manager. Keep Project Management apprised of the situation as it develops and in real time.
What’s the most important job of a CRA?
Ensure that the trial is conducted at the highest level of protection of patient’s safety and right while adhering GCP/ICH rules. The CRA must maintain a very high level of attention to details and conscientiousness.
What would be the first thing you would do when visiting a site 6-8 weeks post initial
Review consent forms and inclusion/exclusion criteria of the new participants. Re examine the data collected on initial participant from first visit. Less
What will you handle a difficult PI?
Set up a meeting with a third person and confront the behaviour that is causing the problem. Focus on the behaviour not the person as behaviour can change but people generally do not.
How would I handle discussing a difficult topic with a site, coworker or client?
Always keep a respectful tone and never take things personally. If I am having difficulty, I would get tips from my manager or mentor on ways to address it
What was the greatest challenge you faced as a new CRA?
Learning new protocols with little to no training
How do you problem solve as a CRA?
identify, isolate and determine root cause analysis.
How would you handle a provider who was not following the protocol?
Re-educate the provider on importance of following protocol and potential of risking subject safety if going outside the parameters of protocol. Then escalate to PM and/or MM
