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Compliance In Focus
Posted by Katelyn Weed on Tue, Sep 8, 2020

4 Ways CRAs Can Keep Research Coordinators Accountable

Research coordinators can bind the clinical research process together to ensure that a trial is efficient and compliant.

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With subject safety, protocol and regulatory compliance, and quality data collection being at the forefront of their crucial role, research coordinators truly are vital to clinical research.

Clinical Research Associates (CRAs) or monitors are responsible for ensuring compliance requirements, maintaining patient safety and protecting data integrity, so it is in the best interest of a CRA to keep research coordinators accountable and engaged throughout the study.

Here are four ways CRAs can promote the continued commitment of research coordinators throughout a clinical study.

1. Show you're on the same team.

Whether it is from a past monitoring experience or a belief passed along from peers, it is not uncommon for research coordinators to have a negative attitude towards monitoring. CRAs can overcome that stigma by showing that they are on the same team.

CRAs should demonstrate their role in partnering with and supporting research coordinators by going above and beyond their tasks of monitoring, such as providing tools or examples alongside documentation errors or regulatory noncompliances that were observed. This could involve providing an example corrective and preventive action plan to include in a report to the IRB or working with the research coordinator to create a visit checklist to ensure all assessments are completed during a study visit.

Regardless of the provided support, helping solve a research coordinator’s challenges goes a long way to building a beneficial relationship. The research coordinator will likely reciprocate the assistance when a CRA requests a task be completed. CRAs can also promote a team-based environment by simply checking in with coordinators to ask if any assistance is needed between visits, by being appreciative, and by recognizing the coordinator’s efforts in conversations with the principal investigator or sponsor.

CRAs and research coordinators working in tandem can help streamline the clinical trial process, getting the treatment or device to market faster. This emphasizes the importance of research coordinators recognizing that CRAs are a teammate, rather than an opponent.

2. Recognize their work style and pain points.

Whether it is a long list of queries that need to be addressed before a data lock or information that requires prompt reporting to the IRB, it is not uncommon for CRAs to have significant requests for research coordinators. Understanding research coordinators’ preferences and challenges when it comes to their day-to-day tasks can help shape the way a CRA interacts with them, resulting in more effective interactions and timely results.

Does a coordinator prefer working through conversations over the phone or through e-mail? Are items more likely to be resolved with shorter, more frequent requests or with a larger, comprehensive list? Could screenshots be used to explain a requested update in the EDC? Are there certain days of the week in which each research coordinator is at their desk versus working with patients in the clinic? These simple acknowledgments will streamline the effort and time needed from the research coordinator to complete CRA requests and recommendations.

A CRA can also keep research coordinators accountable and engaged by addressing their pain points. For example, a CRA might recognize that a busy research coordinator truly intends to address all requested updates discussed during a quick meeting but also realizes that the coordinator will likely get pulled in many other directions on the way back to his or her desk. Therefore, the CRA could follow-up all discussions with an e-mail outlining the conversations and agreed-upon actions to mitigate the chance of any information being forgotten.

If the research coordinator is experiencing difficulty securing protocol compliance with another department (e.g. laboratory or imaging), the CRA could offer to reach out to that department to provide reminders or retraining. The CRA could also prompt the research coordinator to come up with a personal deadline if the CRA observes a pattern of deferment.

3. Give reasons for recommendations or requested changes.

When aiming to secure regulatory compliance, CRAs can find themselves in difficult conversations with study staff. Requesting a site to change their established processes, update source documents, or submit protocol deviations is not always met with a friendly smile. Many research coordinators already face a challenging workload, so requests to redo work can be frustrating.

CRAs can ease frustrations by bringing a reason ‘why’ along with a request or recommendation. Just like CRAs, research coordinators’ priorities lie in subject safety and study ethics. The CRA should consider the FAIR Shake™ framework to explain what the federal regulations, study agreements (FDA Form 1572 or Investigator Agreements), the Investigational Plan or protocol, or the requirements of the IRB say about the topic at hand.

Research coordinators may feel like monitors request changes simply because of personal preferences. Stating the ‘why’ will show the coordinator that the CRA’s request is founded on regulatory compliance and promote trust. For example, a CRA can explain the importance of good documentation practices by referencing GCP E6 (R2) 4.9.0 or reiterate the importance of maintaining sponsor correspondence by pointing to FDA 21 CFR 812.140(a)(1). Equally important, the research coordinator can also provide that same reason ‘why’ to any clinic staff who oppose a tough process change in an already full clinic schedule.

4. Ask for feedback and be appreciative of questions.

Research coordinators are commonly responsible for recording and reporting safety and compliance issues in a timely manner and staying on top of data entry. An open line of communication with research coordinators is vital to ensuring that protocol requirements and updates are conveyed. The more a research coordinator feels heard and understood by a CRA or the sponsor, the more likely that same coordinator will want to engage in a clinical study. Additionally, soliciting feedback from research coordinators can provide insights and challenges that ultimately result in impactful updates to a protocol.

Whether a coordinator needs a bit more training in the EDC or is struggling with reoccurring protocol deviations, understanding the obstacles of each individual research coordinator is easier with forthright communication. Appreciating the feedback and questions that come from research coordinators not only keeps a study progressing forward, but also reminds a coordinator of their value to the study. Both questions and feedback could be prompted through quick monthly phone calls or periodic check-in e-mails with the site.

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Keeping a research coordinator both accountable and engaged throughout the clinical trial life cycle goes beyond scheduling monitoring visits and asking for timely data entry. It stems from an established and reliable relationship with a CRA.

Sometimes research coordinators just need a little understanding. In other situations, they may need extra help. IMARC offers a full range of support services for research coordinators, including on-site screening, data collection and remote records review.

Learn more about how our site support services can lighten your load.

What practices and processes have you found helpful in promoting accountability and engagement with research coordinators?

Topics: Research Coordinators

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