FREQUENTLY ASKED QUESTIONS
What is a Clinical Trial?
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.
What will the Clinical Trials Research Associate Program
teach me?
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.
What will the Clinical Trials Research Associate Program
prepare me to do?
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.
What jobs are available in Clinical Research?
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
followup 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.
How do I become admitted into the program?
Contact the CTRA admissions counselor, Dr. Penny Augustine 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.
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.
Once I am admitted, when can I begin the CTRA program?
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.
Can I complete the program early?
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.
I work during the day. How can I complete the CTRA program?
The CTRA Program was designed with the working professional in mind.
All of the CTR courses are in the evening beginning at 5:45pm. The exception
to this is the fieldwork courses (CTR150 and CTR250) which run during
the business day.
Although the classes are at night, the Fieldwork is held during
the day. How do working students satisfy this requirement?
The Fieldwork program is a critical part of the CTRA 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.
Are graduates of the CTRA program able to get jobs in clinical
research after graduation?
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?
Some positions, such as clinical research associates (CRAs) can require
travel. Other positions require less travel or almost no travel. An occasional
amount of travel may be required to meetings, conferences etc. Speak
to a faculty member to further discuss these options.
I want to get a job in clinical research. How should I go
about it?
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.
Resources:
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.
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