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Seven years ago, I began my second career. I had left my job of 12 years as an elementary school teacher, for a career in ophthalmology research. I had taught “the eye” to my former students, but I quickly learned there was more to it than “what you see.” I was brought on to manage the research administration. I knew nothing of protocols, IRBs, FDA audits, or informed consent. It might as well have been Greek!
Thanks to some amazing sponsors, monitors and IRBs, I quickly learned the basics of this new world of research. I was able to restructure and reorganize the systems we had in place for conducting the studies. I set up training sessions on GCPS and protocols to make sure the staff knew what we were doing. While I had learned enough to manage the studies we were conducting, I was always nervous about telling new sponsors or industry reps my background (and so was my boss, I think). I was afraid they would not see me, or my principal investigator, as credible.
After a year and a half of learning the medicine, I embarked on my certification journey. I first became certified as an ophthalmic assistant. I immediately jumped into getting my research certification. It was time to put some credibility into the work I was doing. After 2 months of studying, I passed the CRC exam.
Immediately, the vibe of our research changed. I was no longer embarrassed to tell people from where I had come. I now look forward to telling them my journey because I know that we are conducting good research. I have used my previous experiences in teaching to help organize and develop new methods of preparing and training for a new study. It is important that I have a clear understanding of GCPs, the consent process and the history of the development of the FDA Regulations and ICH guidelines.
I have joined the ACRP and have been part of the Minnesota chapter programming committee for 2 years. I have helped prepare chapter meetings and presentations, including a certification prep course. I have given several presentations on the research we are doing at our site as well as other topics such as preparing for an FDA audit.
Getting my certification has given me the confidence I need to help build a center of excellence in research. It has allowed me to “walk the walk” and “talk the talk.” It has helped me to discuss various aspects of the studies we do with the sponsors, as well as with my staff. It has given me confidence among my peers that I can share with them things that I have learned, or processes or tools I use to conduct research at my site. It has allowed me to speak with pride about my job. And in case of an FDA audit, I know I am qualified to do my job and manage the research that has been entrusted to me.
What does my certification mean to me: Credibility, Confidence, Assurance!
Thanks to some amazing sponsors, monitors and IRBs, I quickly learned the basics of this new world of research. I was able to restructure and reorganize the systems we had in place for conducting the studies. I set up training sessions on GCPS and protocols to make sure the staff knew what we were doing. While I had learned enough to manage the studies we were conducting, I was always nervous about telling new sponsors or industry reps my background (and so was my boss, I think). I was afraid they would not see me, or my principal investigator, as credible.
After a year and a half of learning the medicine, I embarked on my certification journey. I first became certified as an ophthalmic assistant. I immediately jumped into getting my research certification. It was time to put some credibility into the work I was doing. After 2 months of studying, I passed the CRC exam.
Immediately, the vibe of our research changed. I was no longer embarrassed to tell people from where I had come. I now look forward to telling them my journey because I know that we are conducting good research. I have used my previous experiences in teaching to help organize and develop new methods of preparing and training for a new study. It is important that I have a clear understanding of GCPs, the consent process and the history of the development of the FDA Regulations and ICH guidelines.
I have joined the ACRP and have been part of the Minnesota chapter programming committee for 2 years. I have helped prepare chapter meetings and presentations, including a certification prep course. I have given several presentations on the research we are doing at our site as well as other topics such as preparing for an FDA audit.
Getting my certification has given me the confidence I need to help build a center of excellence in research. It has allowed me to “walk the walk” and “talk the talk.” It has helped me to discuss various aspects of the studies we do with the sponsors, as well as with my staff. It has given me confidence among my peers that I can share with them things that I have learned, or processes or tools I use to conduct research at my site. It has allowed me to speak with pride about my job. And in case of an FDA audit, I know I am qualified to do my job and manage the research that has been entrusted to me.
What does my certification mean to me: Credibility, Confidence, Assurance!
