Frequently Asked Questions

According to clinicaltrials.gov, a service of the U.S. National Institutes of Health, clinical trials, often referred to generally as “clinical research” are “biomedical or health-related research studies in human beings that follow a pre-defined protocol” (http://www.clinicaltrials.gov/ct2/info). Clinical trials may include interventional or observational studies. Specifically, a clinical trial may study the use of a product in human participants for the purposes of obtaining marketing approval of a product so that a physician can prescribe it.  In this case, a clinical trial is a research study, in human subjects/participants, of a drug, medical device, biologic (such as a vaccine) or treatment.  We generally conduct clinical trials on these products to determine if they are safe and effective for use by the general population. 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 research 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. Students also learn about other types of clinical research including non-product interventional studies and observational research.  The program now offers 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 biotechnology 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.

• Pharmaceutical/Device/Biotechnology company or contract research organization (CRO) – CROs are companies who support the work of the Pharmaceutical/Device /Biotechnology 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), regulatory associates, site start-up specialists, 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, academic medical center, independent research site) are where the clinical trial is generally conducted.  Positions available may 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 – Individuals working in clinical data management generally obtain the data collected during a clinical research study 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 Affair – Clinical research is a highly regulated industry.  The work of clinical research professionals must be conducted in compliance with many rules based on federal laws.  Many companies have a department that handles the regulatory aspects of the clinical trial, and for the entire development program for the product that is being studied.  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 marketing applications.

Product Safety/Pharmacovigilance – Individuals working with product safety/pharmacovigilance 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 – Individuals working with quality assurance and auditing ensure that all research activities are conducted in accordance with applicable FDA regulations, guidelines, clinical trial specifications etc.  This is accomplished 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 require extensive education, training and experience in biostatistics.

These are just a few of the areas where clinical research positions may be found.  Please note that there are many others and you may see these areas broken down differently depending on the resource that you review.

Step 1: Learn more about the CTRA program:
Learn more about the CTRA program by viewing the decision chart and program comparison and the CTRA admissions packet. We also offer monthly information sessions to discuss the program including admissions requirements. 

Step 2: Apply to DTCC:
Apply to DTCC and submit your high school and any college transcripts.  An application form and the transcript request form can be found on the web site or apply online at CFNC.org.  If you need assistance with the admissions process, please contact the CTRA Admissions Counselor at 919-536-7202, extension 1105. 

Step 3: Meet program requirements:
Each CTRA program has specific program requirements.  Once you have submitted the application and transcripts, you will be sent a letter detailing what these requirements are.  You should also speak with the CTRA Admissions Counselor at 919-536-7202, extension 1105 to ensure that you have applied to the program most appropriate for you.

Some of these program requirements are as follows:

If you are applying for the degree program (evening or day), 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 a 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 a certificate program. You may also apply for the Certificate Level I 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 the admissions packet for specific information. We also offer monthly information sessions to discuss the program including admissions requirements. 

Courses are offered at night, during the day, or online.  Course schedules depend on when you begin the CTRA program (see the next question for details).  The number of evenings or days you come to class depends on which program you are completing and how many courses are taken during a given semester.

The CTRA program has two different start times.The evening/online program begins only in the fall semester.  Students needing evening or online courses should begin in the fall.  If you are not admitted before that time or are placed on a waiting list, you will have to wait until the following fall to be admitted. 

The day program begins only in the spring semester.  Students needing day classes should begin in the spring.  There are no online classes in the day, spring program.  Students beginning in spring must take the day courses and are not eligible to take evening or online CTR courses.

All students are required to start with CTR 110 Introduction to Clinical Research prior to taking any other CTR courses. Furthermore, courses must be taken in order as indicated on the plan of study.

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

The Data Management certificate begins in the summer semester.  Students must begin with CTR 210 and cannot take subsequent CTR courses until that course is completed.

The CTRA program must be completed in a logical, step-wise manner as specified in the plan of study.  Courses serve as strict prerequisites for the courses that come after them.  Therefore, the program cannot be completed early, nor can CTR courses be taken out of sequence of the plan of study.  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.  Students who withdraw from the program must wait until the missed course is offered again (it may be as long as one year).  Please refer to program information for further clarification.

The evening/online program beginning in the fall semester is the best CTR program choice for you.  All of the CTR courses are in the evening beginning at 5:45 p.m.  The exception to this is the fieldwork courses (CTR 150 and CTR 250) which run during the business day.

The CTR courses are also available in online and hybrid formats.  Please note, however, that seats in the online CTR courses are limited.  Students are not guaranteed seats in the online courses upon admission.  Students are encouraged to visit the distance learning section of the web site.

The Data Management certificate is primarily offered in the evening and online.  Some non-CTR courses that are part of the Data Management certificate may only be offered during the day for some semesters.

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.  CTR 150, held in the fifth semester of the program, is held two days per week.  CTR 250, held in the final semester of the program, is held three days per week.  There are also summer sections of these courses that run three days and five 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 a "leave of absence" in order to complete fieldwork.  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, CTR 220 and CTR 130. CTR 220 is the final course of Certificate Level I and CTR 130 is the first course of Certificate Level II.

Students who are currently working in clinical research settings may not satisfy the fieldwork requirement with work credit transfer.  Also, students may not work at their job to satisfy the fieldwork requirement.  Students must perform their fieldwork rotations at locations other than where they are currently working.  Keep in mind that this is of great value to the student who will get the opportunity to see different clinical research settings to broaden their knowledge of clinical research.

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.  Our students have had tremendous success in identifying entry-level positions in the clinical research industry within six 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.  DTCC has an online career center where students can obtain information about resume and interview skills as well as view job postings. 

Read further for additional comments.

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

Some positions, such as clinical research associates (CRAs) will require travel.  The amount of travel required depends on the company and the studies to which the CRA is assigned. Other positions require minimal to little travel.  An occasional amount of travel may be required to meetings, conferences etc. Furthermore, clinical research is becoming a more global industry.  Occasional overseas travel may be required depending on your position.

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 that most people generally have at that point 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, professionalism and education can take you as far as you want to go.

• Knowledge is good, experience is better – Certainly companies want 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.  Many companies recognize the completion of academic clinical research curriculums like the one at DTCC as “equivalent” to some experience.  Furthermore, the Fieldwork (internship)  component of the Program gives students over 600 hours of hands-on experience in a variety of venues.  The CTRA Programs at DTCC have prepared over 200 clinical research professionals for this industry.  Our students are 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.  If you have related experience, be sure that you have information on your resume that reflects any background in research, science, or medicine.
  
  
• Apply, apply, apply – Because of the above, we encourage our students to apply and to apply often (as often as every three months).  This does not mean flooding a company with a hundred resumes hoping that something will be flagged.  You should have a well-orchestrated strategy to apply to the companies and positions that you want but you should check often for updates and new positions. Be open to different types of positions as well as different companies. In other words, you might get your first job with a CRA but you might find a job in data management that will prepare you well for that career. The CTRA faculty will share positions they become aware of with 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.  Your clinical research network is critical to your initial and ongoing success in this 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.  The CTRA program also hosts an annual career fair that is held every November.
  
  
• 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 provide an excellent way to get experience.  Many companies often promote to higher level positions after one 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 a local job placement/referral organization (staffing/recruitment organizations).  These companies play a valuable role for pharmaceutical, device and biotech companies and contract research organizations in staffing individuals for these positions.  Although these opportunities may be temporary or contract positions, an exemplary job by an individual can often lead to an extended contract or permanent position.  If they do not, you are still getting excellent experience that 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). We will discuss these resources throughout the program.

clinicaltrials.gov: http://www.clinicaltrials.gov/ct2/info

Centerwatch:  http://www.centerwatch.com/patient/backgrnd.html has information about clinical trials including an online glossary of terms

Protecting America’s Health Through Human Drugs. Published by the U.S. Food and Drug Administration Center for Drug Evaluation and Research. (2007). http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143455.htm

Medline Plus Education modules on clinical research http://www.nlm.nih.gov/medlineplus/tutorials/cancerclinicaltrials/htm/index.htm

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

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

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

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)