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.
, Limited time on site, say 3 hours, what would you do? - Correct Answers
How to increase contacts with the PI, or handle a very busy PI? - Correct
Answers
How would I handle discussing a difficult topic with a
site, coworker or client? - Correct Answers 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.
Tell me about a time you faced an ethical dilemma? - Correct Answers
What would you do if you got to a site and they told you they didn't have
time for you? - Correct Answers - 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.
How would you handle a provider who was not following the
Protocol? - Correct Answers 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
What is the CRA job? - Correct Answers -First ling representative for the
sponsor of the trials
-Oversees the activities of the site personnel who are actually carrying out
the clinical research
State a time when you had conflict with a colleague and how you handled
it. - Correct Answers
Provide an example of where you had to think outside of the box? -
Correct Answers
What would you do if you find the findings on informed consent form? -
Correct 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.
, Limited time on site, say 3 hours, what would you do? - Correct Answers
How to increase contacts with the PI, or handle a very busy PI? - Correct
Answers
How would I handle discussing a difficult topic with a
site, coworker or client? - Correct Answers 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.
Tell me about a time you faced an ethical dilemma? - Correct Answers
What would you do if you got to a site and they told you they didn't have
time for you? - Correct Answers - 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.
How would you handle a provider who was not following the
Protocol? - Correct Answers 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
What is the CRA job? - Correct Answers -First ling representative for the
sponsor of the trials
-Oversees the activities of the site personnel who are actually carrying out
the clinical research
State a time when you had conflict with a colleague and how you handled
it. - Correct Answers
Provide an example of where you had to think outside of the box? -
Correct Answers
What would you do if you find the findings on informed consent form? -
Correct Answers
