The Vienna Academy for Workforce Competence in Clinical Research & Digital Site Management Services – VIARES – recently received the IAOCR 5-Star accreditation for its clinical research associates (CRAs) training program.
According to VIARES, it is the first independent organization to achieve the 5-Star accreditation.
Dietmar Eglhofer, CEO and co-founder of VIARES told us the accreditation “marks a key time for the future of the clinical research industry.”
To receive the five-star accreditation, IAOCR – the accrediting organization for the international clinical research industry – completed a six-month assessment. Trainers also were assessed and gained the Qualified Clinical Research Trainer Certification (TIACR).
Eglhofer said development and accreditation of the program is a direct response “to one of the industry’s most present challenges and supports the important change with an increasing focus on competence over years of experience.”
“We are excited to be so involved in this integral industry shift and providing a safe and reliable transition from years of experience to competent new talent for our customers,” he said.
To learn more about the VIARES 5 Star Accreditation, we caught up with Eglhofer to discuss the development process and industry feedback.
What was the goal of creating the industry-newcomers training course?
There is a real talent shortage in the clinical research industry. Over the past few years, we have seen a continued increase in drug development spend, with CROs reporting growth rates over the published growth of the CRA Workforce. Due to the perceived requirement of 2 years’ experience for CRAs we saw shrinking investment in building the CRA Workforce.
As such, there is a real need to provide competence-based training for industry-newcomers that can upskill them to the industry’s required standard and counter this deficit.
The key with our approach is to provide the newcomer a structured way into the industry and the industry assurance that their new talent is the best they can get, accredited by the standards the industry defined with IAOCR.
What has been the feedback?
So far we had a positive uptake from the industry representatives from leaders in Operations, Human Resources, Talent Acquisition and from CEOs. We help them understand the business impact of a solid early talent strategy and program like the VIARES CRA ACADEMY, from operational and financial points of view.
An outstanding example of a true industry veteran comes from Paula Brown Stafford, Chief Development Officer, Novan, Inc. who said, “I am pleased to see the collaboration of three successful entities to identify, train, and qualify a competent pool of clinical research associates (CRAs) for the biopharmaceutical and CRO industries. The awesome difference from other efforts is that IN AWE is focusing on the competency of the individuals, not on the number of years in the job.”
How was the program developed? And who was involved?
The VIARES CRA ACADEMY was developed by industry experts and trainers who are TIACR qualified, based on practical and operational understanding of what new CRAs need to be able to deliver. They have in-depth understanding of the industry requirements through their career in pharma, with CROs and training providers, as well as access to industry veterans on the VIARES board.
In consultation with SEC Recruitment we ensured a true understanding of the challenges newcomers are facing in joining the industry. The trainers and the training program were independently accredited by IAOCR, using a competence-based approach.
What does the program include?
The program addresses the skills, knowledge and behaviors participants need to acquire in order to perform their role effectively and professionally. Areas we cover are basics like GCP and ICH, selecting, managing and monitoring Clinical Trial sites, Investigational Medicinal Product Management, Collecting and Managing Clinical Trial Data and Essential Documents, Regulatory Requirements, Compliance and Quality Assurance, Audits and Inspection.
We also included a range of role-specific soft-skills, like Communicating with Influence, Assertive Negotiation, Risk Management, Project Management and becoming more important Online Communications, to enable efficient collaboration with key stakeholders like sites, sponsors and internal project team. By the time each participant has completed the course, they will have been given a rigorous competence assessment, which will have been independently verified by IAOCR.