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Compliance In Focus
Posted by Katelyn Weed on Mon, Jul 27, 2020

3 Things I Wish I Knew as a Research Coordinator: From a Monitor’s Perspective

While the specific responsibilities and daily tasks for research coordinators can differ, it is irrefutable that research coordinators play an essential and significant role in clinical trials.

In many cases, research coordinators enter the industry with an appreciation for innovation and attention to detail, a background in science or medicine, and a desire to make a positive impact in the health industry. However, there are so many moving parts to being a research coordinator that it can be difficult to initially navigate the position’s demands.

Along with the challenging workload, there can be a considerable amount of understanding needed for the job. From becoming familiar with federal regulations, Good Clinical Practice, study protocols, reporting policies, and new therapeutic areas to navigating relationships with study staff and subjects, research coordinators must balance many competing timelines and expectations.

As someone who started my career in clinical research as an unexperienced research coordinator, there are a few things I wish I had known.

1. Always bring it back to the “why.”

Regulatory compliance is vital for clinical research studies, and it can be difficult to navigate what is required by regulations versus a site’s traditional processes and practices. Additionally, it is not uncommon for research coordinators to be trained with a hands-on approach, in which formal Good Clinical Practice and regulatory training might, unfortunately, be skimmed over. At IMARC, we recognize that training programs differ and may be limited depending on the group or institution, so we have compiled a set of online educational courses tailored to this information for research coordinators and other study staff. By establishing processes and decisions based on regulations, research coordinators can be confident in their degree of compliance rather than leaning on routine practices or a coworker’s opinion.

When faced with a decision, research coordinators can bring the predicament back to the “why” by referencing the FAIR Shake™ framework. The FAIR Shake technique streamlines clinical research regulations to four components:

  1. Federal Regulations
  2. Agreements (FDA Form 1572 or Investigator Agreements)
  3. The Investigational Plan or Protocol
  4. Requirements of the IRB

Whether the pending decision is related to subject enrollment, data recording, or documentation practices, considering the requirements framed in the FAIR Shake™ framework supports a safe, compliant, and ethical clinical study. If faced with a request from a sponsor or monitor, research coordinators should not hesitate to bring the conversation back to the ”why” and discuss how the request relates to FDA regulations, guidance documents, agreements, the protocol, standard operating procedures, site standards, or IRB requirements. Research requires ongoing learning and questions should always be appreciated.

2. Monitors are a resource, not an opponent.

In my experience as a research coordinator, a stigma was instilled in me that clinical research associates (CRAs), or monitors, function as an opposing force looking to document inaccuracies and count nonconformances. Along with the unfortunate stigma, a singular unpleasant experience with an inefficient monitor can taint a research coordinator’s attitude towards monitoring, regardless of the affiliating sponsor or CRO.

From a new perspective, I have realized that monitors can serve as a resource, a partner, and a support system in ensuring regulatory compliance. Just like research coordinators, a monitor’s goal is to protect human subjects and move clinical trials forward. When a monitor suggests a process improvement, discusses the importance of Good Clinical Practice, or asks for a change in documentation practices, the intention may be to bring the research coordinator and clinical site into regulatory compliance to prevent violations to the regulations, signed agreements, the investigational plan, and other conditions of the IRB or FDA.

It was not until I stepped into the shoes of a monitor that my misconstrued perspective shifted; monitors and research coordinators are meant to be on the same team.

Training Guide and Course Catalog 2020

3. Do not be afraid to tell the sponsor what is going well… and what is not.

Working as a new research coordinator, I did not feel confident or experienced enough to discuss the pain points that came with a specific protocol. Now as a monitor, I realize how important candid feedback from research coordinators can be when improving a clinical study.

Research coordinators might struggle with mitigating reoccurring protocol deviations, keeping up with data entry, engaging other study staff, or perhaps responding promptly to queries. Regardless of the struggles, discussing challenges with the monitor might allow them a chance to provide creative solutions to make the research coordinator’s job more efficient. Feedback from research coordinators also gives the sponsor an opportunity to assess if protocol or process changes are warranted.

Clinical research relies heavily on relationships between investigators, the study staff, monitors, and the sponsor. Some of the most impactful changes made to a study protocol can come from a research coordinator’s feedback.

On the contrary, it is just as important for research coordinators to communicate what is going well at their site. These conversations can give the sponsor and monitors insight on successfully implementing the study protocol, which in turn could be relayed to other sites to help keep the study moving forward. Whether it is a tracking tool for study recruitment, a checklist to assist with study visits, or a streamlined flow for onboarding subjects, research coordinators bring such value to clinical trials and should feel confident to share their tips and triumphs.

Conducting clinical research requires the support and effort of a research coordinator, yet those research coordinators have many responsibilities with limited time and resources.

If you once worked as a research coordinator, what is something you wish you would have known?

 

Topics: Research Coordinator

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