Andrea Romito, Data Review Associate
Data is an essential element of clinical research. From collection to processing to analysis, the data managed throughout a clinical trial is key. At Medpace, our team of Data Review Associates are responsible for reviewing the data received from trials for effective and accurate analysis.
This month, Data Review Associate (DRA) Andrea Romito dives into the details of her role responsibilities as a DRA at Medpace. With a background as a Registered Nurse, Andrea brings specialized skills in oncology care to her role where she can contribute to the development of treatments through clinical research.
What is the role of a Data Review Associate within clinical research?
I view the DRA role as important within clinical research as we complete routine manual review of the clinical data collected throughout the duration of a trial. This data cleaning effort helps ensure the record is logical from a medical perspective and accurately reflects each participant’s journey through a trial. This allows clinical data to be as clean as possible for data analysis and helps to ensure the safety of participants while on trial.
How would you describe your role to someone outside of the clinical research industry?
The DRA role mainly consists of manual reviews of clinical data that are guided by edit checks or guidelines created for each study. On a day-to-day basis, the DRAs review clinical data to ensure it is medically consistent with the information available for each review. This includes (but is not limited to) review of Adverse Events, Prior and Concomitant Medications, Medical History, and Laboratory results to detect any missing, incomplete, or inaccurate data that would require query within the Electronic Data Capture (EDC) system for further clarification.
What is one skill you’ve developed and/or honed during your tenure and what is one new skill you’ve learned?
A skill I feel I have developed during my tenure with Medpace is a better understanding of the treatments for cancer patients. As a Registered Nurse, I have always worked in Oncology, and since coming to Medpace, I have been able to develop a much more in-depth understanding of cancer therapies and cancer patient populations overall. One new skill I have learned over my tenure is observing and reporting trends within data while completing reviews. I am now able to pick up on notable trends while reviewing clinical data.
Why did you pursue a career as a DRA?
Since graduating from nursing school, I have always had an interest in clinical research and wanted to be able to contribute to the development of new oncology treatments. I always enjoyed learning about new treatments that were being developed and found the DRA role as one where my experience as a registered nurse could truly contribute to the development of these treatments.
Could you share some insight into the global growth this role is undergoing?
The DRAs currently have team members in the Cincinnati, London, and the Netherlands offices. We also have a new team member that will be joining from India in the new year. The global growth in this role has been impactful with bringing in more perspectives outside of the United States. I have found it interesting and a great learning opportunity connecting with those who have different backgrounds with clinical practice and training experiences before joining Medpace, as I’ve found what would be considered standard treatment locally in the United States for certain diseases/diagnoses can vary greatly depending on the country the treatments were received in.
In your own words, what are three key job responsibilities of the DRA role?
- Performing clinical data reviews as assigned, ensuring established timelines for review assignments are met.
- Reviewing and maintaining study review documents routinely to ensure these are up to date with current information from protocol/protocol amendments or other study-specific materials.
- Communicating within the DRA team and/or Data Management any issues or complications that may arise during the clinical data review as well as escalating appropriately with questions that may come up when performing review of the clinical data.
Find Your Fit
The DRA role is growing across our global campuses. Browse all openings and find your fit at Medpace.
Medpace careers