Clinical Trials Research Associate
Program
Durham
Technical Community College
Introduction
The faculty of the Clinical Trials Research
Associate program is committed to the philosophy and goals of Durham
Technical Community College and to the objectives of the North Carolina
Department of Community Colleges. In its attempt to assist the individual
to develop maximal potential, the faculty supports the “open door
with guided placement” concept. It further recognizes its obligation
to develop and maintain a plan of study which will provide the learner
with a post-secondary education that develops entry level knowledge
and skills required for successful employment.
Program
Mission
The mission of the Clinical Trials Research
Associate program is to prepare individuals to assist investigators
and clinical researchers in the initiation, administration, coordination,
and management of clinical research studies for the development of
new drugs, devices, biologics, and treatment regimens.
Program
Framework
The Clinical Trials Research Associate
program integrates classroom and field experience in a full-time,
seven-semester associate degree course of study offered in the evening
with courses at Durham Technical Community College and various fieldwork
sites. Additionally, two evening four-semester certificate programs
(Level I and Level II) will be offered for professionals with prior
or current work experience in the clinical trials research field.
During the program, the student will obtain
theoretical knowledge in basic product development, Federal regulations,
Good Clinical Practices, and the processes necessary to conduct a
clinical research study. The student will apply this knowledge in
a variety of venues such as working with an investigator at a study
site or working with clinical researchers in a pharmaceutical company
or in a contract research organization. Experiences may include protocol
and case report form development, recruitment and enrollment of human
subjects, informed consent and IRB review, compliance of the clinical
site to regulatory requirements, packaging and inventory accountability
for research drugs/devices, auditing study documentation, and preparing
and responding to CRF queries.
Within this framework, faculty maintain
the curriculum and outcome objectives according to the standards
and guidelines set by the Clinical Trials Research Associate Advisory
Committee. Program students and graduates are provided with academic
counseling, career counseling, recruitment, and job placement assistance.
Graduates will meet the educational requirements required to take
the certification examination for clinical research professionals
offered by a national research organization. Employment opportunities
may include medical centers, hospitals, pharmaceutical industries,
clinics, research facilities, biotech or device companies, and physician
offices.
Clinical Trials Research Associate Programs
Schedule
Effective Fall Semester 2004-2005
Associate
Degree
Evening Program with Daytime
Rotational Fieldwork Experience · 7
Semesters
| Semester |
Course |
Class Hours |
Lab Hours |
Clinic Hours |
Credits |
| |
|
|
|
|
|
Fall
|
BIO 168 Anatomy & Physiology I
|
3
|
3
|
0
|
4
|
| |
CTR 110 Intro to Clin Research
|
3
|
0
|
0
|
3
|
| |
ENG 111 Expository Writing*
|
3
|
0
|
0
|
3
|
| |
|
|
|
|
|
|
Spring
|
BIO 169 Anatomy & Physiology II
|
3
|
3
|
0
|
4
|
| |
CTR 115 Clin Research Regulations
|
3
|
0
|
0
|
3
|
| |
MAT 151 Statistics
|
3
|
0
|
0
|
3
|
| |
|
|
|
|
|
|
Summer
|
CIS 110 Introduction to Computers
|
3
|
3
|
0
|
3
|
| |
CTR 112 Clin Research Terminology
|
3
|
0
|
0
|
3
|
| |
PHI 240 Introduction to Ethics
|
3
|
0
|
0
|
3
|
| |
|
|
|
|
|
|
Fall
|
CTR 220 Research Site Management
|
3
|
0
|
0
|
3
|
| |
CTR 130 Clin Research Management
|
4
|
0
|
0
|
4
|
| |
BIO 271 Pathophysiology
|
3
|
0
|
0
|
3
|
| |
|
|
|
|
|
|
Spring
|
CTR 150 Research Field Work I
|
0
|
0
|
15
|
5
|
| |
CTR 120 Research Protocol Design
|
3
|
0
|
0
|
3
|
| |
PHM 120 Pharmacology I
|
3
|
0
|
0
|
3
|
| |
|
|
|
|
|
|
Summer
|
CTR 210 Research Data and Reports
|
2
|
0
|
0
|
2
|
| |
ENG 112 Argument-Based Research
|
3
|
0
|
0
|
3
|
| |
PHM 125 Pharmacology II
|
3
|
0
|
0
|
3
|
| |
|
|
|
|
|
|
Fall
|
CTR 250 Research Field Work II
|
0
|
0
|
24
|
8
|
| |
CTR 281 Trends in Clinical Research
|
3
|
0
|
0
|
3
|
| |
SOC 225 Social Diversity
|
3
|
0
|
0
|
3
|
| |
|
|
|
|
|
| |
Total Credits
|
|
|
|
71
|
* ENG 070, ENG 080, ENG 090, ENG 090A, MAT 050, MAT 060,
MAT 070, MAT 080, RED 070, RED 080, or RED 090 may be required
based on placement tests.
Clinical Trials Research Associate Programs
Schedule
Effective Fall Semester 2004-2005
Certificate - Level I
Evening Program · 4
Semesters
| Semester |
Course |
Class Hours |
Lab Hours |
Clinic Hours |
Credits |
| |
|
|
|
|
|
|
Fall
|
CTR 110 Intro to Clin Research
|
3
|
0
|
0
|
3
|
| |
|
|
|
|
|
|
Spring
|
CTR 115 Clin Research Regulations
|
3
|
0
|
0
|
3
|
| |
MAT 151 Statistics I
|
3
|
0
|
0
|
3
|
| |
|
|
|
|
|
|
Summer
|
CTR 112 Clin Research Terminology
|
3
|
0
|
0
|
3
|
| |
PHI 240 Introduction to Ethics
|
3
|
0
|
0
|
3
|
| |
|
|
|
|
|
|
Fall
|
CTR 220 Research Site Management
|
3
|
0
|
0
|
3
|
| |
|
|
|
|
|
| |
Total Credits
|
|
|
|
18
|
Certificate - Level II
Evening
Program · 4 Semesters
| Semester |
Course |
Class Hours |
Lab Hours |
Clinic Hours |
Credits |
| |
|
|
|
|
|
|
Fall
|
CTR 130 Clin Research Management
|
4
|
0
|
0
|
4
|
| |
|
|
|
|
|
|
Spring
|
CTR 120 Research Protocol Design
|
3
|
0
|
0
|
3
|
| |
|
|
|
|
|
|
Summer
|
CTR 210 Research Data and Reports
|
2
|
0
|
0
|
2
|
| |
|
|
|
|
|
|
Fall
|
CTR 281 Trends in Clinical Research
|
3
|
0
|
0
|
3
|
| |
SOC 225 Social Diversity
|
3
|
0
|
0
|
3
|
| |
|
|
|
|
|
| |
Total Credits
|
|
|
|
15
|
|
|
|
|
|
|
|
* ENG 070, ENG 080, ENG 090, ENG 090A, MAT 050, MAT 060, MAT 070,
RED 070, RED 080, or RED 090 may be required based on placement tests.
