“Getting into clinical research is a long journey, and it can be a challenge,” said Isabel Brugman, BHSc, MPH, PhD, Senior Clinical Research Associate II at PPD, who spoke to Latinos in Clinical Research recntly. Brugman, who has parlayed her skills into various positions, believes that it is important to learn as much as possible, make connections, be passionate, give 110 percent and put theory into practice.
Brugman had worked in the private sector as an emergency medical technician , then for a hospital and then for a doctor in private practice, all the while obtaining degrees and on-the-job training. Her background is in infectious disease, and she is working on a PhD in epidemiology. She has experience in preventive medicine and a genuine desire to help people.
When the doctor she was working for said he was going to sell his practice, she needed to look for work. She found a job as a laboratory technician with a CRO that had a clinic that had a 24-hour dorm for in-patient and out-patient testing.
She advised, “Get into a clinical research company however you can, build relationships, then show what you can do. Do whatever kinds of work you can, and acquire whatever skills you need. Take an entry-level position if necessary, and always network. Take any study you can in as many areas as you can. Be detailed on reports. Say yes as often as possible.”
Being a CRA is the top of the line, according to Brugman. There is a great demand for CRA positions, Brugman said. The more skills one acquires, the easier it is to get those positions. “Join groups and go to webinars for free training that will make you stronger,” she added.
Working for a sponsor means “belonging to the sponsor,” but the duties can be the same as working for a CRP. Follow the protocol and learn extra duties to become more skillful, Brugman advised. She added, “Utilize and broaden your skills, get as many skills as possible and get certifications. Then put everything on your resume to get your foot in the door, even volunteer positions. Be yourself in interviews.”
Brugman also advised people to teach people new skills, so they can move up. At the same time, learn from other people, be site-friendly and respond right away.
She also discussed risk-based monitoring (RBM), which involves “identifying critical data and processes necessary for human subject protection and integrity of the investigation, conducting a risk assessment, and developing a monitoring plan specific to the investigation. The RBM guidance also encourages sponsors to tailor monitoring plans to the needs of the investigation, describes factors to consider in developing a monitoring plan, and provides examples of monitoring methods and techniques,” according to the FDA. FDA believes risk-based monitoring is “an important tool to allow sponsors to identify and address issues during the conduct of clinical investigations.”
Brugman advised teaching sites “how to do this well enough not to have to babysit.”
What does a typical day look like? Brugman said there may be 50 to 100 patients sometimes, work on Veeva, checking the lab portal and answering correspondence. “Do everything promptly, and the sites will reciprocate,” she said.
