Jeanine van Herkhuizen - Clinical Research Associate (CRA)
1. What is your educational background?
I studied Medical Biology at the VU in Amsterdam
2. What did you do before you joined Quintiles?
Quintiles is my first employer after I graduated as a Master in Medical Biology.
3. How did you learn about Quintiles?
Through Pharmascope! (Pharmascope was a local CRO with mainly recruitment and outsourcing activities. The company was taken over by Quintiles in 2005 and with that came a large database of Clinical Research professionals)
4. In what position did you start and how did you reach the level that you are at right now?
I started as a Clinical Trial Administrator (CTA) within the Study Start-up group. After six months I was promoted to a Start-up CRA. After little more than one year I was promoted to Associate Study Start-up Team Lead. Currently, I’m a monitoring CRA, based at a large pharmaceutical sponsor, conducting two oncology trails and one CNS trial.
5. What are your responsibilities as a CRA?
I’m responsible for the conduct of three trials, from start-up until site close out in the Netherlands. In addition, I’m responsible for the local project management of one trial.
6. What does a day as a CRA look like?
I am currently the monitoring CRA on three different studies with three different drugs and two different therapeutic areas.
As a CRA you have the freedom to organize your own calendar. Depending on where your study sites are located, days can be very long, due to travel time.
My main role as a CRA involves visiting sites, usually two or three days a week. I visit the sites to assess that they have the facilities, staff and patients to successfully complete a study. When a site is elected, I train everyone involved on that study and then it’s a waiting game as the site identifies suitable patients and they consent to take part in the trial!
After the site identifies a patient, this patient is monitored. This means reviewing Case Report Forms (CRFs) for completeness, accuracy and that it is all verifiable against patients’ source notes and documents. During my source document verification, I pay special attention to Serious Adverse Events (SAEs). In addition, I visit the pharmacy for drug accountability.
Apart form the onsite activities, CRA work also involves a lot of administration: documentation of the visits and writing follow-up letters, making telephone calls and writing emails, following-up on unresolved issues and chasing people to make submissions to Ethics Committees.
Finally, a CRA needs to be fully up to date regarding the indication, study drug Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and local rules and regulations. For this reason, I spend a large amount of time in training, medical meetings, investigator meetings and seminars.
7. Five keywords that describe Quintiles best?
Innovative
Dynamic
Flexible
Young
Goal-oriented
8. Why would you advise people to join Quintiles?
See the 5 key-words!
