Health care heroes are everywhere, from surgeons in war zones to pediatric nurses in suburban offices. In trials, clinical research coordinators (CRCs) are priceless members of every trial team. From study startup to study closeout, CRCs make the trial happen.

While the principal investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates, and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.

“When I tell people what I do, they have absolutely no idea what I do,” Misty Dawn Thompson said. She is a CRC at the Riley Hospital Pediatric Pulmonary Allergy and Sleep Medicine Department in Indianapolis.

The CRC position is challenging. It requires a diverse array of professional skills and personality traits. It can be a complex and sometimes exasperating job, but it pays back extraordinary gratification and fulfillment.

Clinical research coordinators at the starting line

The CRC is usually the first person clinical trial participants meet during trial enrollment. Therefore, they must convey honesty, truthfulness, compassion, and a patient engagement focus. Participants may be anxious or hesitant, and if they don’t trust the CRC or they feel their safety is not a priority, they may choose not to enroll. Or they could withdraw before completing the study.

Bridget Gonzales is the senior director of educational programs at the Association of Clinical Research Professionals. She is also a former CRC at a multi-therapeutic clinical research site. She said CRCs must be process-driven “to take a protocol and implement it at the site.” This includes:

• Recruiting participants
• Ensuring patient safety
• Following protocol guidelines
• Collaborating with doctors, study teams, and patients
• Communicating complex concepts in user-friendly terms
• Making critical decisions when everything seems to go wrong

A clinical research coordinator’s typical day

Thompson often runs simultaneous trials with varied timelines. Patients are at separate points, require different tests, and have individual needs. A typical day starts with getting to work an hour early and checking email for updates. Then she meets with participants and gives them breathing tests, draws blood, administers meds, collects medical histories, and reports on adverse events. Additional tasks include cleaning rooms, making patient payments, and doing “lots of data entry.”

A typical day is also filled with unanticipated events which require astute problem-solving and decision-making abilities. “Someone gets stuck in traffic, someone else calls in sick, one person forgets to bring his investigational product back, another loses his wearable device. Then at 4:59 p.m., a serious adverse event occurs, requiring immediate attention,” Gonzales explained. “Sometimes you have the tools to answer these, and sometimes you have to figure it out.”

That’s when leadership and critical thinking skills kick in. The CRC leads the team, under the direction of the principal investigator, to facilitate and coordinate daily protocol-related activities, work around problems, figure out solutions, and communicate with team members and patients, all of whom have varying levels of education, personalities, work styles, and patience.

Larger organizations can offer support teams for the CRC. But smaller organizations, such as those in doctors’ offices, may lack such resources. The principal investigator, with the help of the CRC, runs the entire trial, from startup to closeout, on their own.

Challenge and change

During the Covid pandemic, trials were still conducted and patients still had to be seen. Decentralization and electronic consent, which had been discussed pre-pandemic, prospered as a result. “Critical thinkers are able to shift into new ways quickly,” Gonzales said.

Flexibility is crucial since every day is different. A CRC must be a master multitasker who accepts the unexpected as the norm, collaborates with fellow medical professionals, leads a trial while consulting with the principal investigator, and accepts irregular hours and last-minute changes. Unexpected phone calls during little league games and occasional last-minute runs to the hospital occur.

This is a discerning job that someone who is a hard worker and a fast learner with an abundance of patience and a passion for helping others can fill, Thompson said. “Anyone with a willingness to learn new skills, who has excellent time-management and organizational abilities, and who is honest and willing to put patients first can consider it.” She said that while most CRCs have a medical background, some enter with other majors, such as biology or psychology.

Making a difference

“Patients are so thankful for the work we did,” Gonzales said. “They say, ‘You saved me. Thank you for the science, for creating a future for my children, for providing treatments so they don’t have to suffer like I did.’

At the end of a participant’s participation, on the last day, it’s like a sad parting. Sometimes they would want to hug and to say, ‘Thank you.’ We really had an impact on people. We are advancing medicine and giving cures to people who didn’t have a cure before.”

She said the rewards she gained from being a CRC are deep-rooted and enduring. “I use the skills I learned as a CRC for life. I am always using critical thinking skills as a mom and in all aspects of life. This has been beneficial to me. I continue to build tools to add to the toolbox. I am able to grow in my career, to grow with others, and in my personal life.”

Thompson, a former medical technician in a doctor’s office, has been a CRC for six years and plans to stay there. “It’s pretty easy to do when you see the positive impacts. We are saving lives. I’ve seen people improve their quality of life and it’s so rewarding helping the doctors and scientists learn more about the disease process and patient survival. I feel like they make you want to keep learning and doing what you’re doing.”

Let’s hear from you

Imperial appreciates the valuable work of clinical research coordinators and their vital role in the conduct of studies. We would love to hear what you have to add. Please scroll down and enter your thoughts in the comment box.

This is the second in our blog series celebrating key roles in the clinical trials industry. Read our first blog in the series: https://www.imperialcrs.com/blog/2022/02/07/cros-secret-weapon/