Operating Status

Rutgers has been instrumental in getting the coronavirus vaccines to the public – most recently leading one of the largest phase 3 clinical trials sites in the world for the FDA emergency-use authorized Johnson & Johnson vaccine, which is expected to play a pivotal role in stemming the pandemic.

Behind the university’s crucial efforts at New Jersey Medical School and Robert Wood Johnson Medical School is a Rutgers-led collaborative established two years ago to create clinical trial innovations that can speed the translation of research discoveries into improved patient care.

 “Who could have imagined this would be needed so quickly?” said Barbara Tafuto, instructor in the health informatics department at the School of Health Professions and member of workforce development for the NJ Alliance for Clinical and Translational Science’s $29 million grant program known as NJACTS.

But the global pandemic brought into sharper focus the critical need to educate and train the clinical research workforce, she said. When Johnson & Johnson and Moderna reached out to Rutgers Biomedical and Health Sciences’ clinical trial unit, the workforce development group at NJACTS was uniquely positioned to help.

“They needed to scale up quickly and didn’t have the workforce,” said Barbara Gladson, associate dean for academic affairs at School of Health Professions and co-lead of the workforce development team that sought the grant. She and co-lead Lauren Aleksunes, professor in the Ernest Mario School of Pharmacyare spearheading NJACTS’ workforce development effort, which is part of a multi-million dollar federal grant initiative Rutgers leads in a collaborative partnership with Princeton University and New Jersey Institute of Technology.

The initiative focuses on training and cultivating the clinical research workforce, promoting the integration of underserved populations in clinical trials, innovating processes to increase the quality and efficiency of translational research, and advancing the use of big data information systems.

While their work was put to the test sooner than they ever anticipated in the race to develop a coronavirus vaccine, NJACTS was ready.

The group provided time-sensitive training to existing and newly hired clinical staff. Using funding from the grant, NJACTS purchased 50 licenses for clinical research training modules from the Association of Clinical Research Professionals (ACRP), which certifies clinical trial professionals, and sent 43 people, including students in the School of Health Professions M.S. in Clinical Research Management degree program, through trainings.

One of the students was Lauren Castelli, who has a background in product development and who had completed a clinical research management internship in April. She immersed herself in training modules provided by ACRP and immediately went to work as a clinical trial coordinator obtaining informed consent for trials being conducted for Johnson & Johnson. She said the trainings taught her how to take patient histories, discuss sensitive topics and relay information accurately and without bias, ensuring that participants fully understood the 35-page consent document before agreeing to the trial.

 “Workforce development in clinical and translational science represents a key deliverable for NJACTS," said Reynold A. Panettieri Jr., vice chancellor for Clinical and Translational Science and director of Rutgers Institute for Translational Medicine and Science. “The workforce must be nimble and dynamic to meet current challenges engendered by the pandemic.”

To enhance the foundational training and competencies of students entering the clinical trial research workforce, 11 eight-week student internships were established in pharmacy, nursing, biomedical engineering, clinical research management and medicine.

 “We are filling a void for quality clinical research professionals,” said Doreen Lechner, co-lead of workforce development at NJACTS and program director of the M.S. in Clinical Research Management at the School of Health Professions. “There are just not enough clinical research professionals available.”

There is a critical need for well-trained clinical research professionals, said Lechner. “When companies hire someone who is trained, they have people who come in with the foundational skills of a clinical research professional understanding how to write a protocol, and administering informed consent to submitting regulatory documents,” she said.