Fairplay Consultants, Inc.

References from our clients

"Carolyn delivers cutting-edge instruction through a unique blended learning course environment that takes you step-by-step through the clinical trial development process. By providing a framework for harnessing knowledge, she simulates the nitty-gritty one expects to encounter when you're thrown into the field. While the intensive course may be fleeting, the essential continuity of training is ensured through a spectrum of evaluative self-study material that underscores one's ability to grasp the whole picture and function accordingly. Her people-centered approach makes her an invaluable asset not only in the classroom but in the real world as well. I highly recommend participating in her course."

-- Vincent Alimurung, MD
 

"I was lucky to have such a remarkable instructor as Carolyn Rugloski to help with my Clinical Research Associate training.

The course she developed was equally comprehensive and hands-on. She was an eager and enthusiastic speaker who presented material with ease. Carolyn facilitated the role-playing in mock monitoring visits with great skill. She also provided extremely constructive career guidance and resume evaluation.

Carolyn Rugloski's Clinical Research Associate training is invaluable and extraordinarily effective for people launching careers in Clinical Research."

-- Anna Shapiro
 

"Carolyn Rugloski was the teacher for a "Foundations in Clinical Research" course I took in November 2003. The course was designed to teach the basic principles and practices of clinical trials and explore the fundamentals of clinical trial monitoring. It was aimed at those with no clinical research background as well as those in the industry that wanted a refresher course. The educational requirement to attend the course was a Bachelor of Science in Nursing or Science.

Carolyn has an extensive wealth of experience in the clinical research industry, as evidenced by her knowledge displayed during the course. She explained concepts and practices clearly, and class attendees were always welcome to ask questions. Questions were answered thoroughly and were usually accompanied by an example from Carolyn's own personal work experience, so much that she often got off on tangents!

The courseware and training tools that Carolyn designed for this class were excellent. The course contents were broken up into logical and understandable sections. The slides prepared for each section were clear, concise, and easy-to-read. The information contained in each section had a high degree of relevance to the topic at hand. Carolyn also had additional tools such as examples of documents used during monitoring visits and Code of Federal Regulations / ICH GCP Guidelines books. The monitoring visit documents were used during "mock visits" performed by class attendees and were an invaluable learning tool. After the completion of the course, class attendees had the option of completing an additional 150 hours of independent study. Carolyn designed and provided the materials for this additional coursework. The material was relevant and in-depth. I resigned from my job and devoted significant time to complete this additional coursework.

After I completed the additional coursework, I began my job search in earnest. Carolyn was very responsive when asked to provide references or answer questions of an urgent nature. She kept in touch and was supportive of my job search efforts.

I would highly recommend Carolyn Rugloski as a teacher and designer of a clinical research course. She is highly dedicated, knowledgeable, and cares about her students. "

-- Tiffany Lee, CRA, April 4, 2004
 

"In May of 2003, I graduated from the University of Louisville with a degree in Biology. I had initially decided that Biology was the way to go because I was interested in attending Dental School, but by the time my senior year rolled around, I had changed my mind. So here I was, fresh out of college, with no clue as to what I wanted to do as a career. I really wanted to do something that was closely related to my degree, so I decided to explore possible career opportunities in the pharmaceutical industry. I began researching on the internet different pharmaceutical/biology-based careers, and I came across the Regulatory Affairs profession. This profession appealed to me because it was all about getting forms approved and making sure that the drug approval process was going as I should and following guidelines. My only problem was that most of the jobs listed required knowledge in things like GCP, GMP, and the FDA-areas I really was not familiar with. Nonetheless, I continued to research Regulatory Affairs on the internet, when I received and email from a training vendor. As I was about to delete the message, the flashy red heading caught my eye. The heading read, "Prepare for a Career as a Clinical Research Associate!" I recalled reading about CRA's when I was researching Regulatory Affairs, and I remembered that they both required a lot of the same knowledge. I decided to visit the website to learn more about this CRA training. The Website was very informational. It included a detailed description of the course, prices, and a list of Frequently Asked Questions. Although the website was very informative, I was still a little skeptical. If I chose to take the course, it would be quite an investment, so I wanted to make sure I would be getting my money's worth. I called the number listed on the website and I spoke to the Course Recruiter about my concerns. The Course Recruiter was extremely friendly and helpful, and when I decided to take the course, he made sure I got all of my paperwork in and he even helped me find a cheap flight to California.

On the first day of class, I was a little anxious because I didn't know what to expect, but within the first five minutes of class, I realized I had nothing to feel anxious about. Although the class sizes vary, I was in class with about 10 other students. The trainer was Carolyn Rugloski, and she was great. With over 20 years of clinical research experience behind her, she was very informative. We learned everything from the clinical trail process to what to pack when going on a site visit. With only a short time to learn the fundamentals of Clinical Research, the class was very intense. We met 8 hours a day for 5 days. For example, we learned about the Phases and Regulations of Clinical Research, the history of Clinical Research, the informed consent process, and the risks and responsibilities of the FDA, CDER, and Sponsors/CRO's-and that was just the first day! All in all, I think that the course was very beneficial and will help make me more marketable in the biotechnology industry. Now that I am finished with the course, I am actively looking for an entry-level job Regulatory Affairs or Clinical Research. With this course, I feel confident that I know what I will need to know to successfully perform on the job. To anyone who is interested in starting a career in the biotechnology field, the FCI "CCRP Foundations of Clinical Research" course is a great starting point."

-- Lydia Keys