A Day in the Life of a Clinical Research Coordinator

We recently got the chance to speak with Jeimy Rosado, Clinical Trials Program Manager at Vitalief. Jeimy is new to Vitalief, but she is not new to clinical trials. She brings over a dozen years of practical experience in clinical trial administration. Jeimy is very energetic and clearly enjoys her work. Her enthusiasm is contagious. As we talked, it was obvious that Jeimy is thoughtful about her career path, purpose, and the broader clinical trial profession. In this discussion, she shares some of her practical experiences and perspectives on clinical trial management. 

What is a Clinical Research Coordinator?

The job of a Clinical Research Coordinator (CRC) is to ensure that a clinical trial, be it observational or interventional, is well conducted and follows GCP guidelines. A CRC typically must wear many hats, but screening patients is probably one of the first/most important tasks a CRC conducts because it determines whether a patient is eligible for a particular trial. The inclusion/exclusion criteria must always be reviewed with the Principal Investigator or Sub-Investigator prior to enrolling a patient in a study. 

What does a CRC do in a typical day?

CRCs typically interact with patients, technicians, nurses, physician assistants, doctors, and other administrative personnel. If it is determined that the patient meets the criteria for a study, the CRC will then conduct the Informed Consent Process with the patient and schedule the follow-up telephone/clinic visits to collect the data needed for the trial.

The CRC must then:

  • Enter the data in the relevant systems
  • Ensure that the proper billing is done for the trial
  • Answer queries issued by the sponsor to clean up the data
  • Do daily checks for patients’ adverse events in the Electronic Medical Record system

Because there are so many moving parts involved in conducting a clinical trial, it is the CRC’s job to prioritize his/her daily tasks and the order in which each should be completed.

What do you like the most about being a CRC?

I am happy to be able to help a patient (albeit in a small way) find alternative/better solutions for the treatment of a disease. That is the most rewarding part of the job; feeling as though you are contributing to the greater good and making a difference.

What do you find most challenging?

One of the most challenging aspects of working as a CRC is ensuring that while the clinical trial is being conducted the data collected is of quality and that small things do not fall through the cracks. There are many tasks to be completed on any given day, and the pace can be overwhelming.

Another challenge involves the Principal Investigator’s (PI’s) availability to review, sign, and assess the data and any adverse events that occur while the trial is being conducted. It is crucial that this gets done in a timely fashion as there are deadlines imposed by the sponsor, especially during times when the data needs to be locked to be presented to the FDA.

How did you get into this field? What drew you to it?

I was interested in public health but wanted to take part in a project like the Peace Corps. I decided to take a chance and get involved in the field of Public Health at a time when the job market was awful. I was struggling to find work after the market crash of 2008/2009. I realized that in this field there will always be jobs available and that it is very rewarding if you pursue it for the right reasons.

I have gotten so much professional and personal satisfaction working with clinical staff to help patients. I have learned so much. Because each trial is different and each patient population has different needs, I continue to learn and feel that I gain so much from that experience. So here I am, 13 years later!

What skills do you need to be a good CRC?

Having great interpersonal skills is vital for CRCs to do their job. This is important, as the CRCs will interact with patients, administrative, and clinical personnel daily. Roadblocks will always come up but good communication throughout those interactions always helps. 

What advice would you give to someone entering the field? 

  • Be prepared to be challenged regularly; a CRC’s job is not easy. The job can be stressful but also fulfilling!
  • Work on building relationships with both the clinical and administrative personnel, as they will all be an integral part of your day-to-day activities.
  • Do not be afraid to ask for help from your peers, management, the PIs, clinical staff, etc.
  • Feel confident in your ability to make decisions as you will not always have someone readily available to assist you.

Why did you choose Vitalief as the next step in your professional journey?

During my job search, I interviewed with multiple companies and spoke with several hiring managers. I decided to join the Vitalief team because I believe in their mission. The company’s “people first” mantra is why I felt it was the right career move for me.

It is so motivating to know that Vitalief is genuinely invested in creating a thriving career path for each one of its employees. As a functional service provider (FSP) supporting clinical trials, the company is constantly rethinking current practices and envisioning new solutions that drive improved outcomes. I was seeking an entrepreneurial career that would support my personal and professional growth and I found it with Vitalief.

Grow Your Clinical Trial Management Career with Vitalief

Jeimy’s insight and experiences help us to better understand the responsibilities, challenges, and personal and professional advantages of being a Clinical Research Coordinator. It is clear why she is good at her job and making her mark in the clinical trial industry. 

If you are a CRC interested in learning more about Vitalief or joining our team of clinical trial coordinators in New York, New Jersey, and Pennsylvania, send a note to joinus@vitalief.com or contact us today.

The Evolving Role of the Clinical Research Coordinator

Clinical Research Coordinators (CRCs) hold a pivotal position and are critical to the success of a clinical trial. These multi-talented team members are often required to be a “Jack-of-All-Trades.” Florence Healthcare describes the CRC as “the “heart” of a clinical trial – the champion of the protocol, the guardian of the patients, the taskmaster of the research team.” They manage numerous details of the trial, such as eligibility criteria and adverse event (AE) reporting, while also being responsible for broader communications with trial participants, principal investigators (PIs), trial sponsors, and external labs.

One of the critical responsibilities of a CRC is to maintain essential information about the conduct of the trial. The Good Clinical Practices (GCP) requires much of this information, and noncompliance can result in institutional review board (IRB) sanctions or withdrawal of study funding. 

There are many other pressures on CRCs. As noted in the 2019 Survey by the Italian Group of Clinical Research Coordinators (GIDM) and conducted among their membership, the average number of studies followed by the interviewees was 12.4 actively enrolling trials, and 10.6 trials closed for recruitment. At the time of the interview, only a few respondents could rely on a stable contract, permanent- (21.4%) or fixed-term (12.5%), while most (66.1%) worked through diverse temporary contracts (e.g., freelance, or project-based contracts). 

Varying contractual obligations with sponsors create extra pressures often exacerbated by a continuous flow of protocol changes throughout the trial. These typically set off a flurry of distributing, updating, and redistributing documents. It’s essential to manage and track all these activities under strict study timelines for compliance purposes.

A Myriad of Clinical Trial Technologies

The clinical research coordinator can be viewed as the hub of a wheel with spokes that connect them to stakeholders across the clinical research ecosystem. They are often required to learn and use different data capture, collaboration, and analysis tools.

Understanding the technologies and their strengths and weaknesses becomes a vital part of the role. As more clinical trials move toward hybrid and virtual designs, CRCs must keep up with evolving technologies used within various trials. For example, CRCs can now acquire informed consent from trial participants remotely via eConsent. CRCs need to be comfortable using the different enabling technologies to ensure compliance and patient safety.

clinical research coordinator

The Voice of the Clinical Research Coordinator

As clinical trial ecosystems introduce new technologies, CRCs will ensure these new solutions provide adequate support for the trial’s objectives and don’t diminish the team’s abilities to interact with patients or quickly discern issues. Their voice will be important in shaping the future’s use of technology.

For example, telemedicine has offered the ability for healthcare providers to engage and interact with patients remotely. As the “face” of a trial, CRCs often build relationships with patients and other stakeholders that support the study objectives and encourage patients to participate in future trials. Technologies should help in these efforts and not hinder them.

Hybrid and virtual trials, a new and growing focus on patient-centered trials, and increasingly complex trial designs will continue to impact the duties of CRCs. This environment will continue to pose new challenges and new opportunities. In a blog titled, “The Anatomy of a Great Clinical Research Coordinator,” on the Association of Clinical Research Professionals (ACRP) website, the authors suggest that a dedicated support system including professional development and Principal Investigator (PI) mentoring will enable CRCs to grow professionally and personally. Organizational support for this critical role will continue to be imperative as the dynamics of clinical trials continue to change.

Contact Vitalief for Clinical Trial Solutions and Support

Running a clinical trial requires hard-working staff and problem-proof solutions and support. Whether you need help hiring staff such as a Clinical Research Coordinator, attracting patients, or managing processes, Vitalief offers a solution. Contact us today to learn how our people-first culture can become an asset to your organization.