Research coordinator reflects on nearly a decade of running clinical trials, team approach

There is never a dull moment for Hannah Lee, a research coordinator who manages clinical trials for Seattle Cancer Care Alliance (SCCA) patients. Research coordinators work with providers, patients and pharmaceutical companies to ensure participants meet all requirements to enroll and be treated within clinical study protocols.

“I like to see us as the middle person between everything that takes place in the clinic and the sponsors of our trials,” said Lee, who manages the Phase 1 Clinical Trials Program’s research coordinator team.

Lee joined SCCA as a pharmacy technician in 2009 after working in New York City in a similar role and seeing the positive impact new medications could have on the lives of patients. In 2013, she transitioned to a research coordinator role within the Phase 1 Program for SCCA patients. Phase 1 program trials offer innovative new therapy options to patients with advanced cancer when conventional treatments no longer work.

The role also fit with her interest in project management and in collecting and sharing information.

“Communication is a key part of my job,” said Lee. “On one side, you have all of the clinic activities, staff and patients, and on the other, you have the pharmaceutical companies who are sponsoring and managing the trial. We serve as a bridge.”

To keep everything operating, Lee and her team start from the beginning with the protocols for each trial. Research coordinators go through and review the protocol and other documents for the study – often hundreds of pages of information – and determine what needs to happen from beginning to end.

“We make sure we know the schedule and procedures,” said Lee. Research coordinators help enroll patients and schedule clinic visits, lab draws, infusion visits, scans, biopsies, etc., depending on the specific procedures required.

“I feel very honored that I get to be a part of patient care in this way,” said Lee. “It’s a responsibility I do not take lightly because I have a part to play in actively helping a patient. I like to make sure they feel like they have a life outside the clinic, so part of scheduling everything is also making sure all these needs are met, such as the patient being able to go on vacation.”

To keep the trial running smoothly, research coordinators also work closely with regulatory coordinators, who stay up-to-date in federal, state and institutional guidelines, and with data coordinators, who help collect necessary information for each trial. They also work with the SCCA finance team to be sure all trials follow billing compliance.

“We also collect data. We love data,” said Lee.

This information is collected to understand how a cancer is responding to the study medication. Collecting and sharing this data is also important when it comes to understanding side effects and knowing about potential medication interactions.

To take on the role of a research coordinator, it takes a combination of organizational skills and flexibility to meet the needs of patients and the clinical trial’s objectives.

“We really try our best to make sure patients feel comfortable participating in a clinical trial, which is of course completely voluntary. We realize all this information we’re collecting wouldn’t be possible without their participation, so we really care about their comfort and how they feel throughout the process. Patients often tell me they were glad they participated in a clinical trial. They see it as something altruistic they can do.”

Another rewarding part of the research coordinator role is seeing a drug go from a Phase 1 trial all the way to FDA approval – something that has happened for a handful of medications since Lee joined the team.

Lee has also personally seen many patients who have benefited from a trial and gone on for many years with no evidence of cancer.

“I can see the impact many of these clinical trials have had on patients’ lives,” she said.