CRA Screening Questions
Your full legal Name XXXXXXXXXXX
Your Location (City, State) Baltimore, Maryland.
Currently employment (co. name, title, role) AbbVie, Clinical Research Associate II
What is your motivation to entertain joining AZ at this I will like to play a pivotal role by contributing my
time? experience and expertise in AstraZeneca's
scientific capabilities to make a positive impact on
changing patients’ lives.
And having read AstraZeneca's values and
behaviors, and with the great reviews seen online,
I am convinced it is a great fit for my abilities and
career goals.
Please highlight your experience and why you would I am a driven and result-oriented Clinical
best fit BRIEFLY this role. Research Professional with experience in the
conduct and monitoring of Phase I to Phase IV
clinical trials. In-depth knowledge and
understanding of ICH-GCP guidelines and FDA
regulations.
I am confident that my knowledge of relevant
therapeutic areas and ability to work in an
environment of remote collaborators makes me
the best fit for this role.
What Therapeutic areas and specific indications do CARDIOVASCULAR: Aneurysm, Heart
you experience monitoring? Failure, Coronary Artery Disease, Stroke.
ONCOLOGY: Solid Tumors, Lymphoma,
Melanoma, Breast Cancer.
IMMUNOLOGY: Psoriatic arthritis, Rheumatoid
arthritis.
RESPIRATORY: Asthma, Bronchitis, Influenza.
INFECTIOUS DISEASES: COVID-19
(Vaccine).
How many years have you monitored? I have been monitoring for 5 years now, and I
have 5 years in oncology monitoring.
How much is Oncology monitoring?
Which phases of research have you monitored? I have monitored Phase I to Phase IV clinical
trials.
Have you performed all types of monitoring visits? Yes, I have conducted site qualification visits, site
Please list. initiation visits, monitoring visits, and close-out
visits.
How many total visits would you say that you have I have more than 300 visits.
performed in your career? Guestimate?
What is the most number of protocols you’ve been 4 protocols, 16 sites.
responsible for you at once time? Most sites?
Please share what industry-specific CTMS: Impact, Infolink 2, RightTrack, and
systems/applications you have experience with? (e.g. eclinical.
CTMS, EDC, eTMF) EDC: DataLabs, Rave, Inform, OracleEDC and
Medidata.
eTMF: Veevavault, Metadata
IWRS: Arone IWRS, IXRS IWRS
When you go on-site for a monitoring visit, what are I ensure the following 3 are specially taken care
your top 3 priorities for that visit? of:
I. Action items from the last visit
reviewed.
II. Site’s compliance with protocol and
applicable regulatory requirements.
III. Data integrity and quality confirmed.
What is your process is for reviewing an Informed To verify the correct submission of Informed
Consent Form? Consent Forms, I do the following:
•I ensure the correct version of the informed
consent was used and that it has a stamp from the
Institutional Review Board (IRB).
•I review the pagination to make certain it is
correct.
•I confirm all required initials and/or signatures
are present.
•I verify the date corresponds with the date of
consent.
•I confirm the consent process is documented in
the source
•I ensure any checkboxes for notifying the
participant’s Primary Care Physician (PCP) or
authorizing any additional sample tests are
completed with either yes or no.
What was the most challenging site you’ve ever I once worked with a site that was not familiar
managed (no names pls)? Why was it challenging and with the EDC system that the study was utilizing,
what did you do? Be brief. the site was also not familiar with the data entry
requirement of the study and the site was not
entering data into the EDC within 3-5 business
days. Prior to my monitoring visit, I will always
double-check the EDC to ensure all data has been
entered and that system-generated queries have
been responded to.
Do you have any study lead experience? If so, for No
how long, and did you have Line MGT duties?
Where is your nearest airport and how far away is it? Baltimore-Washington International Airport is the
(For smaller airports, what kind of direct flights do closest to me. It is a 24-minute drive away, and
they have?) there are several direct flights.
Tell me about the current geographical region you National, from coast to coast,75% of the time.
cover and the percentage. What is your expectation?
How many days on site are you presently spending I currently perform 8 days on site. My current
and what is your current company metrics? company’s days on-site requirements is 8.
What is your current process with booking travel and I automate this using SAP Concur.
expenses?
How much notice do you need to give your current I need to give my current employer 2-weeks’
employer? notice before leaving.
How soon can you start work?
What is your salary expectation to make a move? A minimum of $100,000 annually.
Do you have any interviews or offers pending at this I don't have any interviews or job offers right now.
time, and if so, where do you stand with them?
What days/ times over the next 2 weeks are you free to I am readily available for an interview on Monday
interview? through Friday over the next two weeks, provided
there’s a 24hr notice.
Do you now or in the future require sponsorship? No
