The importance of Clinical Research Associate training to support effective trials
The clinical trial landscape is witnessing an increase in Phase III trials that average more than 3,500 patients. As more of these large trials continue to emerge, many contract research organizations (CROs) and sponsors are struggling to recruit qualified clinical research associates (CRAs) to support the influx of work.
Lack of experienced talent represents one of the main challenges facing the market, impacting sponsors and CROs alike with increased costs and extended timelines. Yet the urgent need for qualified CRAs will continue given that the demand in the field is projected to grow by 36.4% from 2012 to 20221 in the U.S., an issue also reflected worldwide.
Examining Recruitment Barriers
The clinical trial industry is acutely aware of the pressures. To stay abreast of this urgent situation, as noted in the Association of Clinical Research Professionals (ACRP) position paper, A New Approach to Developing the CRA Workforce, the industry needs to assess current standard operating procedures (SOPs) and examine barriers blocking new talent from filling positions.
At Covance, we followed this guidance and brought together our leaders to holistically assess the market and our current investments. We found the industry truly lacked a harmonized global training program to develop CRAs—early in their careers—creating a major hurdle for job seekers. Furthermore, many scam training programs offer dubious certifications to CRA candidates interested in building skills within the field.
Proactively Growing the Talent Pool
Recognizing this gap in training, we developed a global program to attract and retain talented people: the Covance Monitoring Excellence Academy (MEA). We wanted to give candidates from around the world the opportunity to grow into the CRA role, which ultimately enriches our lifeblood for the good of patients and transforms how we manage clinical trials.
The academy is more than a simple training program. MEA establishes an accelerated path through tailored scientific courses, interactive modules, hands-on experience, and an ongoing mentoring program. Trainees receive a solid foundation that lays the groundwork for a rewarding career path.
Building the Pathway to Success
The Covance Monitoring Excellence Academy is designed with two pathways to hire staff and train them in a standardized global fashion. The first path focuses on what we call the CRA “Assistant Role.” These candidates have the relevant education but limited experience in a clinical research setting. With guidance from experienced team members, they can work at in-house roles and learn all the aspects of being a CRA, creating the perfect opportunity for recent graduates looking for a fasttracked career path as a CRA.
Industry experienced staff, such as research nurses, site study coordinators, or clinical research coordinators are ideal for the second path. Here, the MEA courses teach them how to effectively manage sites in clinical trials as a CRA. In many cases, these staff are remote employees, working from their home offices while in the MEA program.
Regardless of the pathway, we’ve found that trained staff feels empowered to bring a more consistent approach to how they monitor and manage sites, reinforcing our drive for quality, accuracy, and excellence. And, the CRA team, having diverse backgrounds with varied experience levels, offers a more innovative, holistic, and unique perspective, using a “critical eye” to judiciously manage our trials—a true value to everyone.
A Flexible Curriculum, Focused on Growth
The MEA program offers tailored tracks based on a candidate’s individual level of industry knowledge and experience. Over a three-to six-month period, participants advance their clinical operation competencies through a comprehensive blended face-to-face and web-based curriculum:
|Regional Training Modules||Allows candidates to participate in training modules based on experience in the industry–ranging from team roles and responsibilities to clinical trial design to remote monitoring|
|Clinical Foundations||Provides an overview of activities, processes, and components of a clinical trial, emphasizing the roles and responsibilities of the sponsor, sites, ethics committees, and CRAs|
|Peer Support and Observational Training||Offers participants the opportunity to partner with and observe skilled CRAs to further develop competencies, expand critical thinking skills, and gain co-monitoring experience|
|Regional Case Studies, as applicable||Encourages learning via scenario-based training case studies created from corrective and preventive actions (CAPAs) and examples from Clinical Quality Control (CQC) visit findings|
Supporting Employees, Clients, and Trials
Through the MEA program, graduates gain comprehensive real-world experience and a thorough understanding of GCP and ICH regulatory requirements, all while working in a supportive network of skilled and trained CRAs.
Participants work with a regional point person who provides real-time support when questions arise and ensures the individuals understand all aspects of the clinical trial monitoring through the MEA program period and beyond— before accepting any individual assignments. This process ensures the highest data quality for more successful site performance.
Providing the First Line of Defense
“In any clinical trial, data integrity and patient safety are our top priorities,” said Dr. Rob Davie, Vice President and General Manager for Global Phase II-IV, Clinical Development. “As dedicated research professionals who are knowledgeable about the science of monitoring and its collaborative nature, CRAs represent the first line of defense. That’s why we work hard at Covance to invest in talent through the Covance Monitoring Excellence Academy.”
With deep experience, a reputation for quality, and therapeutic area expertise across the entire development spectrum— from nonclinical through Phase IV and safety monitoring—Covance understands the essential role of skilled CRAs in successful trials. “Clients can expect to partner with innovative individuals committed to ongoing quality in clinical research,” said Davie. “Likewise, CRAs can expect that we’ll reward their efforts from the moment they walk in the door.”
As a partner in this collaborative, talent-building process, we continue to hear from our clients how satisfied they are with the MEA coursework and the knowledgebase of their new enthusiastic CRAs.
- Bureau of Labor Statistics
Monique Heiser Wong, Senior Manager, Clinical Development Services, Covance Inc
If you’d like to learn more about Covance’s extensive clinical solutions or the Monitoring Excellence Academy opportunity, please visit Careers.Covance.com/CovanceCRA.