How To Create Efficiencies in Daily Clinical Trial Monitoring

by | Nov 8, 2021 | CRA/CRC Tools | 0 comments

Clinical Research Associates (CRAs) are extremely important members of Clinical Research Teams, and play a crucial role with clinical trial oversight.

A CRA acts as a liaison between a research study Sponsor or Clinical Research Organization (CRO) and the clinic where the study is taking place. An article on MHA Online says that the role of a Clinical Research Associate is critical in making sure that study results are not influenced by the Sponsor or CRO.

Along with keeping the results transparent, CRAs are also integral in ensuring accurate results so that the medications, devices and procedures that are being studied are both safe and effective for those patients on the study and future patients. To ensure this accuracy, CRAs are responsible for documentation, organization, and effective communication.

Most Clinical Research Associates are involved with multiple clinical trials at a time, and the workload can be intense. CRA Burnout is a common issue due to the significant amount of work and travel that can be required of CRAs. In order to instill a better work/life balance, it is important to create efficiencies in daily tasks and monitoring. These efficiencies will benefit both the Sponsor and CRO and the CRA.

This article outlines typical daily responsibilities of a Clinical Research Associate and discusses specific opportunities for creating efficiencies in daily tasks and monitoring that can lead to greater job success for experienced and new CRAs alike.

Daily Responsibilities for CRAs in a Clinical Trial

Daily responsibilities are dependent on the stage of the clinical trial. Since most Clinical Research Associates work on multiple trials at a time and each trial may be in a different stage, it is likely that a CRA’s day will include all or some of the following tasks.

Before the Research Trial Begins

CRAs start their work on clinical trials long before the actual research begins. One of the initial tasks is to conduct site selection visits to qualify potential study physicians and study sites for participation in the trial. During the site selection visits, CRAs ensure the site has all necessary personnel, equipment, and access to the participant population under study.

Following the site selection visits, the CRA authors a report for the internal clinical trial team that details site findings and their recommendation for which site is the best choice for the trial.

When a site is selected, the CRA may assist with questions on the site’s regulatory documents, contract/budget, or Institutional Review Board (IRB) submission.

Site Initiation

After a site is selected, the CRA is responsible for educating the clinical research site team about the Sponsor’s protocol in detail during a site initiation visit. The CRA confirms that all trial approvals are in place, verify the receipt of the study drug and other supplies, train the site team and ensure system access is available to all applicable staff. The site initiation visit is very important and the foundation to a successful study start.

Additionally, the CRA assists the site with brainstorming on pre-screening activities. The CRA is available to answer any questions that the clinical research site team may have during this visit and sets expectations for their visit monitoring visit once screening begins at the site.

During the Research Trial

Throughout the research trial, the CRA will typically visit the site in person every 4-8 weeks, depending on the study and/or the site’s recruitment rate. If an on-site visit is not possible, the visit may be conducted remotely.

Once a trial participant is enrolled, CRAs are responsible for reviewing patient data in the study source folder, electronic case report forms, and medical charts. This is key to ensuring patient safety and data integrity and confirming the patient met eligibility.

Furthermore, CRAs monitor site activities to ensure the study protocol, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)/Good Clinical Practice (GCP) principles, and local regulations are being followed. If a CRA finds that a site is not meeting the study protocol’s or regulatory requirements, they implement action plans to get the site back on track.

Developing and maintaining relationships with the clinical site staff is another important part of the Clinical Research Associate’s role.

Conclusion of the Research Trial

When a research trial ends, the CRA ensures all activities at the site have been completed, including IRB closure. The CRA reconciles and returns study supplies, and reviews the study obligations with the study physician.

This article from MHA Online says that the most successful Clinical Research Associates are detail-oriented, organized, multi-tasking, effective communicators who like variety in their work responsibilities and are interested in clinical research! With this said, there are still opportunities for Sponsors and CROs to create streamlined efficiencies that will benefit both their CRAs as well as their organizations.

How to Improve CRA Efficiency

Prioritizing CRA efficiency is more important than ever and as outlined above there are many types of visits that CRAs have to perform so any efficiencies they can create would be helpful. Sponsors and CROs are realizing the connection between the heavy workloads caused by increased numbers of clinical trials, CRA burnout, and CRA turnover are leading to delayed studies and overspent budgets! Creating efficiencies for Clinical Research Associates can yield positive results for CRAs, Sponsors, and CROs to ensure the overall success of the trial.

Here are two opportunities to create efficiencies in daily tasks and monitoring:

1. Proper Training to Set Up the CRA for Success

Training Clinical Research Associates, particularly CRAs who are new to clinical research, can be a long and time-consuming process.

Different Forms of CRA Training

This training can come in the form of Sponsor or CRO training on specific processes, such as Standard Operating Procedures, clinical trial training, and/or career-related training on CRA job responsibilities. Proper training is essential to set up the CRA for success.

The training can be simplified and when the same methods from training are used in the field, the work can become more efficient.

For example, CRA Audit Notes from ClinEssentials can be used as a training tool.

How to use CRA Audit Notes as a Training Tool

CRA Audit Notes, pre-printed with industry phrases, are color-coded and quickly outline the action steps they require. Therefore, when CRA Audit Notes are used during training, new CRAs will know and understand how to begin a trial in an organized fashion and maintain that organization throughout. This results in more efficient CRAs and trials.

Official Certifications for CRAs

Clinical Research Associates also benefit from training programs that result in certifications that could lead to better clinical research jobs or salary increases.

The Association of Clinical Research Professionals (ACRP) offers the Certified Clinical Research Associate (CCRA) Certification that is awarded to CRAs who meet eligibility requirements, demonstrate proficiency in specific knowledge and job-related skills, and pass the certification exam.

Another training opportunity is from the Certified Clinical Research Professionals Society (CCRPS), which offers the Advanced Clinical Research Associate Certificate (ACRAC.)

2. Digitalizing Clinical Trials for More Efficiency

According to an article on the ProMetrika website, some CROs and Sponsors have started using electronic forms rather than handwritten documents, faxes, and emails. The advantages include greater efficiency due to more legible communication and the ability to precisely track the forms.

Since remote monitoring of clinical trials has increased, the development of online portals is increasing as well. Online portals are used by site monitors to access data, and are seen as an efficient way to monitor because everyone involved in the trial has access to the same information and can observe the trial at any time.

3. Standardizing Work

Standardization formalizes processes and creates accountability, which can effectively increase productivity and efficiency. It allows more tasks to be completed correctly the first time, thereby eliminating inefficiency. ₇

For CRAs, standardization is a time-saving technique that will ultimately allow them to focus on the most important parts of their clinical trials. ClinEssentials has partnered with BlueCloud by HealthCarePoint to help standardize clinical research trials.

CRA Audit Notes from ClinEssentials allow CRAs and their clinical research teams to standardize their processes. CRA Audit Notes enable teammates to clearly see the topic, next steps, and whether or not it’s been completed. This standardization keeps everyone on the same page, which increases efficiency.

For example, Brian S. is a CRA who uses CRA Audit Notes. Brian reported “My sites and I have created an efficient system. They love the use of the CRA Audit Notes line during my monitoring visits. I am seeing a much faster rate of action item closure because of them. The colors help point out urgent issues.”

Another CRA, Karen Z., has a favorite item from ClinEssentials: “The action item carbonless pads and visit to do lists are my favorite. I love lists and love that I can write my actions once and give a copy to the coordinator and keep a copy for myself.” Since she only has to write her action items one time and in the same place, Karen is able to be more efficient and organized.

Why It’s Important to Create Efficiencies in Monitoring

There are many reasons to make creating efficiencies in monitoring a priority.

Efficiency allows Clinical Research Associates to take their monitoring to the next level. Creating efficiencies will save time, allow CRAs to work smarter, and be more organized and effective.

Alleviating repetitive work through these efficiencies will help CRAs deliver quality results, on time, and within budget. Streamlining will lead to successful, high-quality results. Isn’t that what a CRA’s job is all about?!

For more tools that help Clinical Research Associates work more efficiently, visit our webshop.

If you do something that helps increase your efficiency for your job in clinical research, please comment below! We are always looking for new ideas to share – and we may include it in an upcoming resource!

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