• Email Address: hello@greenkeyllc.com
  • Phone Number: 888-368-5336
Submit Your Resume
Home › Pharma › Technology Is Transforming the Clinical Research Workforce

Technology Is Transforming the Clinical Research Workforce

06Jun
Green KeyPharma

The clinical research workforce is facing a transformation brought about by the rapid changes in how clinical trials are conducted.

New roles are already emerging, while traditional roles are evolving as decentralization and the technology to support the trend require new skills to effectively manage a trial where researchers and patient may rarely, if ever, meet in person.

A new whitepaper from the Association of Clinical Research Professionals details these trends, providing a glimpse at what it means for the workforce and what the industry – researchers and the companies that support them – must do to be ready for the fast arriving future.

“Spurred in part by the ongoing COVID-19 pandemic, [decentralized clinical trials] are bringing more technology to clinical research and along with it the promise of greater efficiency, productivity, and effectiveness,” says Jim Kremidas, ACRP’s executive director. “But to fully realize that potential, roles will need to evolve and operate differently to accommodate this new environment.”

Produced by a group that included representation from technology suppliers, contract research organizations, sites, and more, the whitepaper reached four major conclusions:

  • The majority of clinical trials that implement decentralization, at least in the short term, will be hybrid trials, and aspects of decentralization (e.g. virtual visits) will be leveraged more often and receive more overall acceptance by industry due to COVID-19.
  • Increased use of technology will impact nearly every role. But rather than being a threat to job roles, it will generate the need for the evolution of existing roles and bring unprecedented flexibility and efficiency.
  • New roles likely to emerge include Tech Trainer for CROs, Site Tech Support, Remote Trial Coordinator, Decentralized Investigator, Virtual Patient Guide, and more.
  • Technology training must be standard practice and written into each site manual and delegation log.

In addition to highlighting the growing use of technology – including remote monitoring devices — The Impact of Increased Technology Use on the Clinical Research Workforce defines fully decentralized and “hybrid” trials, discusses the impact of technology workforce roles and details the emerging new jobs.

Photo by Lucas Vasques on Unsplash

[bdp_post_carousel]

Related Post

Pharma
Jun 6, 2023

What’s the Difference Between the COVID Vaccines?

Pharma
Jun 6, 2023

What’s the Difference Between the COVID Vaccines?

With the approval last month of the Moderna vaccine by the Food and Drug Administration, we now have two COVID-19 vaccines available. Two more – one from Johnson & Johnson the other from AstraZeneca – are on the way and could be approved as soon as February.

Healthcare workers, residents of nursing facilities and some first responders have already received the Pfizer vaccine, the first one approved by the FDA. Moderna has begun shipping its vaccine with the first of the 25 million initial doses administered last month.

People eager to be immunized have inundated doctors’ offices and clinics asking when the vaccine will be available. The best answer is soon.

Which one, though, will you receive? And does it make any difference?

The answer to the first question is whichever vaccine can be obtained the quickest or, in some cases, whichever your health plan recommends. It really doesn’t make any difference to you.

Both vaccines require two separate doses to reach maximum effectiveness 21 days apart for Pfizer and 28 days for the Moderna version. Both protect about equally well. The FDA data shows Pfizer is 95% effective after both doses. Moderna is 94.1%.

Unlike most other vaccines, these two vaccines use pieces of protein from the SARS-CoV-2 virus to prompt the body to create antibodies. Conventional vaccines, like the annual flu shot, are manufactured from viruses typically grown in chicken eggs. These chicken grown viruses are then killed or weakened to become vaccines.

The COVID vaccines employ messenger RNA (mRNA), a newer technology. These vaccines “teach” the body to replicate the little bit of the CoV-2 protein, which, in turn, creates an immune response causing the body to make the antibodies that provide the protection against the virus.

The most significant difference between the Moderna and the Pfizer vaccines is how they must be stored. Both can survive for a few days in standard refrigeration. For longer periods, the less stable Pfizer vaccine must be kept in ultra-low temperatures below -94 F. That makes shipping and storing Pfizer’s vaccine somewhat more complicated, especially outside urban areas where the low temperature refrigeration is not easily available.

“At the end of the day, these two vaccines are pretty similar,” Dr. Thomas Russo, professor and chief of infectious disease at the State University of New York, tells Health. “Grab it while you can.”

Photo by Hakan Nural

[bdp_post_carousel]

Read Continue
 
Required 'Candidate' login to applying this job. Click here to logout And try again