Clinical Research Associate
As a Clinical Research Associate, Omara is responsible for overseeing the safe organisation of Clinical Trials. “Mainly I’m looking after the monitoring aspect of a clinical trial, but I’m also coordinating applications to regulatory authorities, submissions of reports that need to be made, regulatory documents that need to be sent out to sites etc,” she says. “I’m also responsible for the day to day management of the trial, so organisation and implementation of trial related duties is in my hands.”
Omara’s days are varied. Some days she will make visits to sites participating in the trial for monitoring purposes, to make sure that the volunteers’ who have consented to partake in the trial have case report forms filled out correctly, and that their medical information matches the patient information on files elsewhere. If there are any Serious Adverse Events (volunteers reacting badly to treatment), Omara follows these up with phone calls to the Principal Investigator and the Research team to ensure the patients symptoms are resolved as soon as possible.,
Omara originally studied pharmaceutical science, but her interest in Clinical Trials was sparked when a close relative was diagnosed with cancer. “After I completed my degree, my initial aim was trying to find out a bit more about cancer, so I looked up postgraduate degrees, and I came across a good opportunity, an MSc in Cancer Therapeutics”.
“That’s where the whole aspect of clinical trials was introduced to me, so I understood that new drugs being produced in line with the newly developing science have to undergo clinical trials. For example, all these new drugs that are targeting certain pathways or certain molecules … they don’t administer these to patients straightaway, it has to go through a series of trials starting from a Phase I trial, to a Phase II trial, then a Phase III trial—and then it’s eventually out in the market. And that also intrigued me. So basically, any drug that we take has to go through a couple of years of experimenting.”