CRA Journal

CRA Journal

Wondering what it’s like to be a clinical research associate (CRA) at Quintiles? Check out our CRA journal, where one CRA shares a personal look into her work life. While her days may not be the same, every day is demanding but rewarding. She’s found work worth doing — making a difference in global healthcare.

Sherry S. – Clinical Research Associate 

Tuesday – Road Warrior

6:00AM
Wake-up, get ready for my day.
6:30AM
Drive to the airport and park.
7:00AM
Go through the airport security line and grab breakfast from an airport restaurant.
8:45AM
Arrive in Washington and grab a cab.
9:00AM
Arrive at site, sign site visit log, and meet with Regulatory Coordinator. I ask her if she has submitted the latest addendum to the Investigator Brochure to the local Institutional Review Board (IRB) per the follow-up letter from my previous visit. She informs me that the IRB is scheduled to review the document at a meeting the following week.
9:15AM
Check to make sure that corrections from my previous visit were made and properly captured on the Case Report Forms (CRFs). Pull properly completed pages. Check for recently received queries from Quintiles Data Management.
10:30AM
Begin to review subjects who have had study visits since the last monitoring visit. Check to make sure the subjects signed the newest Informed Consent Form during their visits. Check that all documents are signed off by the principal investigator. Request necessary corrections.
2:45PM
Perform drug accountability activities. Check for shipments received from the last visit as well as the current amount of drug on hand and the earliest expiration date. Check storage temperature logs. Purge expired lab kits from the inventory and alert the study coordinator to use the laboratory vendor's order sheet to order additional kits.
3:45PM
Meet with the Principal Investigator, Regulatory Coordinator, and Study Coordinator. Review deviations: one of the subjects did not sign the latest Informed Consent Form during the correct visit and a different subject had a visit outside the visit window. Ask if anyone has any outstanding questions or concerns and thank them for their hard work on the trial.
4:00PM
Seal up the drug to be returned to the depot as well as the envelope of CRF pages to be sent to Data Management and place them in the courier pickup area in the laboratory.
4:10PM
Say my goodbyes to the study staff and catch a cab back to the airport.
4:30PM
Arrive at the airport, use the self-service check-in kiosk, and proceed to the security line. Grab some soup and salad from one of the airport restaurants.
5:10PM
Board flight back home and read a fashion magazine.
6:30PM
Land, proceed to parking shuttle, pay for parking and drive back home while talking to loved ones on the phone.
7:00PM
Arrive home, check email. Clean the day's receipts out of my purse. Double check the time of the team teleconference the following day.
7:15PM
Relax…

Thursday – A Day in the Office

8:00AM
Listen to a pre-recorded presentation I was unable to attend earlier in the week while simultaneously reviewing and replying to emails.
9:30AM
Have a telephone call with my line manager where we discuss issues encountered during the previous two weeks as well as my upcoming visits.
10:15AM
Take call from a site staff member with a question regarding conducting an emergency resupply of a Study Agent. A dose was prepared and not dispensed due to an adverse event. Instruct the staff member about how to resupply and properly document the situation.
10:30AM
Write a Telephone Contact Report about the call and notify the site's assigned monitor as well as my Team Leader.
11:00AM
Register for a couple of upcoming training sessions per advice from my Line Manager.
11:15AM
Make corrections to three trip reports per guidance from my Trip Report Reviewer.
12:00PM
Attend teleconference for a Human Immunodeficiency Virus (HIV) study, where I am able to get a couple of burning questions answered.
12:30PM
Get some lunch at the cafeteria with a coworker.
1:00PM
Follow-up with Team Leader regarding a login issue with a sponsor's proprietary software.
1:15PM
Receive call from a Study Coordinator in Alabama confirming a Close-Out Visit. I let her know that I will be accompanied by a mentee and give her a brief summary of what we will need for the visit and get the scoop on parking at the site.
1:30PM
Follow-up with my mentee and email him some of the documents to be used for the Close-Out Visit.
1:50PM
Follow-up with one of my HIV sites regarding a Quality of Life (QOL) questionnaire issue.
2:05PM
Exchange instant messages with my mentee about the upcoming visit.
2:20PM
Book travel arrangements for Birmingham.
2:45PM
Take a coffee break.
2:50PM
Follow-up with Clinical Trials Assistant (CTA) regarding the questionnaire issue and resolution.
3:00PM
Work on a Site Visit Report (SVR) from a visit earlier in the week.
3:50PM
Fax deviation logs to CTA team as well as a copy of the follow-up letter associated with the SVR.
4:00PM
Complete and submit expense reports from two recent visits.
4:30PM
Request additional paper Case Report Form (CRF) binders from my CTA as well as additional unplanned visit CRF pages.
4:35PM
Login to a Sponsor's proprietary central file system and check to see if an approval is present.
4:45PM
Fill out my timesheet for the week.
4:50PM
Head out for the weekend!