The Association of Clinical Research Professionals (ACRP) and Merck, along with other leading organizations, have been advocating the professionalization of the clinical trial workforce. In February, ACRP released a harmonized Core Competency Framework for clinical research associates (CRAs) that defines the core competencies required of clinical trial monitors/CRAs within the eight core competence domains for clinical research professionals, as defined by the Joint Task Force (JTF) for Clinical Trial Competence.
The framework is open for public review and comment through March 5, 2017.
The harmonized CRA Core Competency Framework is the product of a cross-industry, multi-stakeholder Task Force and Steering Committee led by ACRP whose contributors include representation from leading industry and academic organizations across the global clinical research enterprise.
Mark Travers is the executive director of global monitoring excellence in the Global Clinical Trial Operation division at Merck. He’s excited about how core competencies can be leveraged to improve clinical trials on levels. ACRP spoke with him recently to get his take on why this shift is a critical next step toward professionalizing the clinical trial workforce to meet tomorrow’s demands.
Q: How would a CRA competency framework be helpful to Merck and perhaps similar organizations?
Travers: [The important thing is that] we can adapt our training to adopt the requirements and needs [being addressed in the framework]. What we’ve done is create a CRA training curriculum that matches the competencies so that, as CRAs progress within their mastery and our expectations of them increase, our training follows the competencies and we give them the tools and training to do the job.
What that means is that if you know what the competencies are to do the job, [you can ask yourself if] you have those competencies. If someone doesn’t have the competencies, can we train the CRA and the CRA manager to have a much more fruitful discussion with respect to their development and their career path.
Q: How is standardization important from your perspective at Merck?
Travers: There is, for me, a need for standardization. We would like CRAs to uniformly accomplish their task when they go on monitoring visits. When you’ve got a global organization of maybe 1,500/1,600 CRAs working in about 50 countries, you need the reassurance that everybody is doing basically the same thing every day at each site. That, for me, is important for the CRA function in terms of standardizing what we expect them to do when they go on a monitoring visit or when they conduct a monitoring visit over the telephone.
There is, for me, a need for standardization. We would like CRAs to uniformly accomplish their task when they go on monitoring visits.
There’s [also the issue of] continuity. You can look at it in a global basis and say, “Well, we know that our CRAs are completing the following [and] they are reviewing the following.” We do need standardization because when we are inspected by authorities they look at our standard operating procedures and guidelines, and they are saying to us, “Are you doing this in all of the countries at all of the investigational sites?” Without standardization, we can’t really say yes or no. With standardization, we can say, “Yeah, 95% is done,”, and it’s accomplished, and the CRAs are following our monitoring standards (following this path for all of the monitoring procedures).
Q: Clearly, standardization of CRA competencies will improve operations.
Travers: Yeah, I think so. [At Merck now] we have standards, we have operating procedures, we have several guidelines. I am in the newly created position of global head of monitoring excellence. This was created to bring greater standardization to the global monitoring organization, and we’re beginning to do that. We’re looking at processes, we’re looking at procedures, we’re looking at technology, and more.
This was created to bring greater standardization to the global monitoring organization, and we’re beginning to do that. We’re looking at processes, we’re looking at procedures, we’re looking at technology, and more.
Q: What kind of challenges have you faced as an organization because of the lack of standardization in clinical trial operations?
Travers: Lack of standardization is probably too strong a term. What you find is a slight adaptation of the process at a local level dealing with local conditions and local cultures. I think that what we want to do is have a framework that we can refer to, but with a little bit of leeway, a little bit of customization at the country level. We have a lot of well trained and experienced CRAs, but we do have some country-level differences that we’re aware of and that we support; however, the main job of the CRAs is universal in the organization.