Please read on for answers to often-asked questions concerning a career in clinical trials research and Durham Tech's Clinical Trials Research Associate program:

A clinical trial is a research study in humans of a drug, medical device, biologic (such as a vaccine) or treatment. Individuals who volunteer to participate in a clinical trial are called “subjects” or “participants”. We generally conduct clinical trials on these products to determine if they are safe and effective for use by the general population. For example, pharmaceutical products must be tested in clinical trials before they are approved to be prescribed by a doctor. Oversight of these products is the responsibility of the Food and Drug Administration (FDA). Therefore, clinical trials are also under the FDA’s jurisdiction and oversight.

During the Program, students obtain theoretical knowledge in basic product development, regulations, good clinical practice and processes necessary to conduct a clinical research trial. Specifically, students in the Program learn all aspects of conducting a clinical trial including the process for bringing a product “to market”, the individuals involved in conducting a clinical trial, and working with clinical research data. They also learn the regulations that are imposed by the FDA to conduct such trials. The Program emphasizes ethical treatment of clinical trial participants and teaches about various ethical doctrine, informed consent, ethical conduct of clinical trials and research in special populations.

The material is taught from several different perspectives including, the pharmaceutical/device/biotechnology Sponsor initiating and overseeing the trial, the research site that conducts the trial, the data management personnel who work with and “clean” the data etc. We now offer a specialized certificate in Clinical Data Management.

The Clinical Trials Research Associate program prepares individuals to assist investigators and clinical researchers in the initiation, administration, coordination and management of clinical research trials for the development of new drugs, devices, biologics and treatment regimens.

The student applies this knowledge in a variety of venues such as a research site (including medical centers and hospitals), a pharmaceutical, device or biotech company or a contract research organization (CRO). Experiences may include recruitment and enrollment of human subjects, administering informed consent, review of study documentation, correspondence with research sites, working with research data etc.

The DTCC CTRA program can prepare individuals for a variety of entry level positions. A few of these positions are noted below. Jobs in the clinical research industry may be categorized as follows (please note that these categories, positions, their responsibilities and job qualifications will vary company to company):

Clinical Research (Clinical Operations)- Individuals who work in clinical operations generally work with the design, initiation, conduct, and follow up of clinical trials. These individuals may work for the Pharma/Device/Biotech company or contract research organization (CRO) or the research site.

Pharma/Device/Biotech company or contract research organization (CRO)- CROs are companies who support the work of the Pharma/Device /Biotech companies. Many individuals get their first jobs with a CRO and it is very important to get this kind of experience. These individuals interact with the research sites and work with the data. Positions include (but are not limited to) research assistants, clinical research associates (CRA), project managers etc. They perform many functions including investigator selection, review and maintenance of study documents, ensure the accuracy of the data, ensure the adequate conduct of the trial according to federal regulations, correspond with research sites etc.

Research Sites (hospital, medical center, independent research site) are where the clinical trial is generally conducted. Positions available would likely include that of a research assistant, study coordinator, or clinical research associate. These individuals work with the clinical trial participants and generally assist in collecting clinical trial data.

Clinical Data Management- This area generally obtains the data from clinical research/operations or research sites and is responsible for entering it into a database, correcting and cleaning the data by querying the research site and assisting with verification and analysis of the data. Common positions include data assistants or data managers.

Regulatory Affairs- This area generally handles the regulatory aspect of the clinical trial, and for the entire development program for a product for that matter. Individuals working in this area may interact with the FDA and other regulatory agencies, ensuring that all trials are conducted according to FDA specifications, working with study documents and applications etc.

Drug Safety- May be responsible for working with the safety information that is learned about a product. During a clinical trial, we obtain information about “adverse events”. This information must be reviewed to ensure its accuracy. Any errors and “gaps” in the information must be resolved. This information is consolidated, analyzed and becomes an important part of an application to gain marketing approval of a product. Positions in this area generally require some medical background such as nursing and may require clinical research experience.

Quality Assurance/Auditing- This area ensures that all research activities are conducted in accordance with applicable FDA regulations, guidelines, clinical trial specifications etc. This is done by performing independent reviews of various aspects of clinical trials. These positions often require clinical research experience and special training.

Medical Writing- This area prepares multiple documents required for clinical research. These documents might include clinical research protocols, study reports, safety narratives and reports or regulatory submissions to the FDA or other agencies. Positions in this area generally require experience and specialized training.

Biostatistics- Play a critical role in the review and analysis of clinical trial data. These individuals provide critical input into how the data should be collected, analyzed and reported. These positions are highly trained in statistics.

These are just a few of the areas where clinical research positions may be found. Please note that there are many others.

Contact Dr. Penny Augustine, Director of Admissions and Testing at (919)686-3619. She will be able to send an admissions packet with an application, transcript request forms and admissions information. You will be asked to complete the application, and submit an official high school transcript or GED scores. If you have a two-year or four-year degree and submit your official college transcript, you will not be required to submit a high school transcript.

If you are applying for the degree program, you will be asked to take the admissions placement tests for English, reading, math, and elementary algebra. Your scores on these tests will determine if you will be required to take any developmental courses prior to admission to the CTRA program. You may also need to complete a biology and chemistry course (both with labs) to qualify for the degree program. Previous college courses or high school courses that are less than five years old will satisfy this requirement.

If you are applying to the Certificate program, you must submit a college transcript that documents completion of college-level English and math. If you have not completed this coursework, you will be asked to take the admissions placement tests for English, reading, math, and elementary algebra. Your scores on these tests will determine if you will be required to take any developmental courses prior to admission to the CTRA Certificate program. You will also be asked to submit a letter from your employer (on company letterhead) indicating at least one year of employment in the clinical research field. A resume and/or job description is also helpful in verifying your qualification for the Certificate program. You may also apply for the Certificate Level program if you have a science degree within 5 years. Admission to the Data Management Certificate requires verification of direct work experiences or completion of one of the two certificate programs.

All admission steps, including completion of required developmental courses, must be completed prior to being added to the list of qualified students. Students are admitted on a "first come, first serve" basis. Once the number of qualified students on the admissions list is exceeded, a waiting list will be started. Please refer to your admissions packet or call Dr Penny Augustine at (919) 686-3619 for additional information and questions.

The CTRA Programs have a single start time and begin in the Fall semester. All students are required to start with CTR110 Introduction to Clinical Research, as well as other courses in the Plan of Study. These students should work closely with their advisor to ensure that they meet the requirements of the Plan of Study and complete all Program pre-requisites.

There are no other approved Program start times, however, a student may take any non-CTR courses in anticipation of program start to eliminate some Program of Study requirements prior to formal program admission.

The CTRA Program is structured to be completed in a logical, step wise manner as specified in the Plan of Study. Courses serve as strict pre-requisites for the courses that come after them. Therefore, the Program cannot be completed early, nor can CTR courses be taken out of sequence. A student can, however, complete non-CTR courses prior to admission to the program, or at other semesters than specified in the Plan of Study where these courses could be completed early. This is subject to availability of those courses and exceptions do apply where the course serves as a prerequisite for another course. Please refer to Program information for further clarification.

The CTRA Program was designed with the working professional in mind. All of the CTR courses are in the evening beginning at 5:45 p.m. The exception to this is the fieldwork courses (CTR150 and CTR250) which run during the business day. Some non-CTR courses that are part of the Data Management certificate may only be offered during the day.

The Fieldwork program is a critical part of the CTRA associate degree curriculum. For two semesters, students are sent to a company performing clinical research where they get direct industry experience. Because clinical research companies conduct the majority of their business during the daytime hours, it is necessary that Fieldwork also run during this time. CTR150, held in the 5th semester of the program, is held 2 days per week. CTR250, held in the final semester of the program, is held 3 days per week. There are also summer sections of these courses that run 3 days and 5 days per week respectively. Fieldwork is unpaid.

Many students work at their current job up to the time of their first fieldwork rotation. At that point, it is a personal decision of the student how they will handle their fieldwork semesters. Some students work this out with their employers to be away for their fieldwork or take "leave of absences". Others take part time employment that accommodates their fieldwork schedule.

Students must complete Fieldwork in order to proceed with the remainder of the CTR coursework. Please speak with the program Fieldwork Coordinator for more information.

Certificate Level I and II students may also participate in fieldwork courses. In order to be eligible for fieldwork, students must complete 2 core courses, CTR220 and CTR130. CTR220 is the final course of Certificate Level I and CTR130 is the first course of Certificate Level II. Both are offered in the Fall semester and an online offering of CTR220 is also offered in Spring.

The clinical research industry recognizes the CTRA Program as one that provides excellent training for many entry level positions. Many companies, academic medical centers and research sites are eager for our students to complete the program so that they can be available for employment. Thus, our students have had tremendous success in identifying entry level positions in the clinical research industry within 6 months of program completion.

DTCC has many resources available to students who are looking for jobs including resume review and workshops about finding employment and interviewing strategies. Additionally, the CTRA program holds an annual job fair where companies attend to meet with and interview CTRA students for positions they may have. The Program also maintains a job board outside of the Program Director's office which posts available positions.

See below for additional comments.

I have heard that clinical research associates travel a lot. Is that true?

Many individuals who ask this question have already learned that when they have inquired about a clinical research position in a company, the likely response has been “You do not have experience.” The question which most generally have then is “How can I get experience if you do not hire me?”. It is true that obtaining a position in clinical research is challenging when you are just starting out but some of the strategies below have helped many “break into the business”. As those of us in the industry often say, “Once you’re in, you’re in”, meaning, once you have obtained a position in the clinical research industry, hard work, initiative, enthusiasm and education can take you as far as you want to go in this industry.

• Knowledge is good, experience is better- Certainly companies would love to hire only individuals with one or more years of clinical research experience. However, companies also look at other things including education. Having a background and degree in clinical research, nursing, science, health science, public health etc can help you to obtain a clinical research position. Clinical research curriculums like the one at DTCC are being noticed by companies and some are recognizing completion of these programs as “equivalent” to some experience. Furthermore, the Fieldwork semesters in our Program give students over 600 hours of hands-on experience in a variety of venues. The CTRA Programs at DTCC have prepared over 100 clinical research professionals for this industry. Our students are 100% employable. One company commented that students coming out of our Program had more knowledge than some of their employees who had 3 years of experience.
  
• “With just a little luck…”- What many people do not tell you about getting a position in clinical research is that, in addition to knowledge and experience, it often also takes luck and timing. The clinical research industry is “cyclic” meaning that the need for personnel fluctuates based on ongoing projects. Although your resume may not get noticed this week, a company may need someone of just your experience 4 weeks from now. We encourage our students to apply and to apply often (as often as every 3 months). The CTRA faculty will post any positions that they are notified about to share them with the program students.
  
• Who do you know? Another way that you might increase your chances of obtaining a clinical research position is by your contacts in the industry. A friend who works for a pharmaceutical company or contract research organization might be able to deliver your resume into the hands of someone who is hiring. This direct approach, and the “good word” of the friend may also open some doors. One way that the CTRA program can help is by notifying the program students of various networking opportunities such as local chapter meetings of the Society of Clinical Research Associates (SoCRA) and Association of Clinical Research Professional (ACRP). These are excellent opportunities to meet and network with other clinical research professionals in the industry.
  
• Be prepared to start over- When you are starting, or perhaps changing careers, you must be willing to start in an entry level position. Although this frustrates some, it is important to note that these entry level positions are some of the most important support positions in the clinical research field. These positions will be called different things in different companies but you can expect positions like “Clinical Research Assistant”, “Data Assistant” etc. These “assistant” positions are an excellent way to get experience. Many companies often promote to higher level positions after 1 year.
  
• Look where you would not expect- Consider looking for positions in areas that you would not think you would be interested in such as at a research site or in an area such as data management. You might begin by going to local job placement/referral organizations (temp organizations). These companies play a valuable role for pharmaceutical, device and biotech companies and contract research organizations in placing individuals in these positions. Although these opportunities may be temporary, an exemplary job by an individual can often lead to extended contracts or permanent positions. If they do not, you are still getting excellent experience which can build your resume.
  
• Tour the World… (…Wide Web, that is). Many internet sites either specialize in or post clinical research positions. These sites include those of professional organizations or commercial sites such as monster.com (as well as many others). These sites are not only places to locate jobs but also to get job assistance (such as resumes, interview skills, etc). Your CTR faculty will have these resources available.

From Test Tube to Patient: Improving Health Through Human Drugs. Published by the US Food and Drug Administration Center for Drug Evaluation and Research. (1999). http://www.fda.gov/fdac/special/newdrug/ndd_toc.html

So You Want to Be a CRA: A guide to careers in clinical Research (5th ed). Published by Ingenix Pharmaceutical Services (1999).

Stonier, PD (ed), Discovering New Medicines- Careers in Pharmaceutical Research and Development. John Wiley and Sons (1994).

Zivin, JA. Understanding Clinical Trials. Scientific American, April 2000 (p 69-75)

Spilker B. (1997) Guide to Clinical Trials. Philadelphia: Lippincott-Raven Publishers.

Centerwatch http://www.centerwatch.com/patient/backgrnd.html (go here for more information about clinical trials including an online glossary of terms)

Lui, M. and Davis, K. Lessons from a Horse Named Jim (2001) Duke Clinical Research Institute.