CWWeekly presents this feature as a way to put the spotlight on issues faced by executives in the clinical trials space. Melissa Mauriber is vice president, clinical operations quality and talent development, of Advanced Clinical in Deerfield, Ill.

Q: Given the variety of classroom and online CRA training and education programs, what prompted Advanced Clinical to create Advanced Clinical University? What set your education efforts apart from more established CRA training organizations, and will you also run CRA certification programs for CRAs with just a few years of experience?

A: [We participated] in a West Coast roundtable discussion where the big­gest industry challenge was identified as having a shortage of qualified talent. Advanced Clinical knew it had a respon­sibility to address this gap. As executives further discussed, the talent that often does present has a superficial skill set and overinflated expectations for titles and salaries.

So couple this dynamic with the evolv­ing risk-based monitoring demands and the expectation that clinical trial teams consists of experienced and analytical talent. Advanced Clinical embraced the opportunity to design, in depth, a new curriculum consisting of didactic and clinical rotations that address these needs.

As for whether we will run certification programs for individuals with just a few years of experience, our initial plans are to run Advanced Clinical University for candidates with little to no experience such that we can bring new talent to the field of clinical research. Candidates of Advanced Clinical University will include recent graduates possessing life science degrees, as well as those with statistical or bio-statistical degrees.

The initial pilot program we are about to launch is for five students, who upon gradua­tion will have jobs at Advanced Clinical, or to be placed through our Staffing Divisions, which will bear the cost of this program.

Taking growth into consideration, we would not discount training junior level CRAs in the future.

Q: As more clinical trials are launched with few participants due to personalized medicine, rare diseases and CNS research, how do you see the CRA’s role and job responsibilities changing to meet some new requirements in monitoring complex clinical programs including competency in risk-based monitoring dynamics?

A: This is one of the very reasons why we are evolving Advanced Clinical University. The clinical research landscape is changing and so is clinical monitoring. Sponsors are asking for risk-based monitoring and centralized monitoring options. We need to train and provide CRAs with the tools to monitor those trials effectively.

The CRA population now is very familiar with the traditional source document verification and source data review methods of monitoring. Hav­ing the opportunity to train a new generation of CRAs on the analytical tools that supports risk-based monitoring and the changing guidance is very exciting.

As for other CRA changes, we are work­ing with a risk-based monitoring analytical tool as are most CROs and I think for the new generation of CRAs that are coming out into the industry—as with the current CRA population—I think for all CRAs, this risk-based monitoring approach is going to be new to everyone.

Q: What parts of the curriculum for CRA candidates do you expect will be the toughest for students to master? Will the new Advanced Clinical University be linked or affiliated with either Association of Clinical Re­search Professionals (ACRP) and/or the Society of Clinical Research Associates (SoCRA)? What role will those associations play in Advanced Clinical University?

A: The biggest challenge for the students will not necessarily be the classrooms or the courses, but rather shifting the mindset of the sites to evolve with the changes in clinical research. As I mentioned, remote/risk-based monitoring is becoming more prevalent. Once we arm our CRAs with proper training, it will be their responsibility to educate the sites properly, so that remote-based monitoring can be successful.

As far as SoCRA and ACRP, both of those organizations offer professional certification. They each require a minimum number of years of field experience in or­der to achieve that certification. Our candidates will not have enough experience to achieve their certification initially. Ideally, once Advanced Clinical University is established and under way, we would like to see all of our curriculum to be recognized for certification use, CEU credits for by either or both of those organizations.

The graduates of Advanced Clinical University will be eligible to sit for the profes­sional certification exams as soon as they have met the pre-requisites for field experience requirements which varies based upon their educational degrees. At a minimum, SoCRA requires 1,750 hours as a clinical research professional. The ACRP minimum requirement is 3,000 hours conducting CRA job responsibili­ties. Along with those hours are educational requirements, which vary between the two organizations. Advanced Clinical will prepare our graduates for these exams by providing the clinical research education and experience needed.

Email comments to Ronald at ronald.rosenberg@centerwatch.com. Follow @RonRCW

This article was reprinted from Volume 19, Issue 36, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »