CLINICAL TRIALS RESEARCH ASSOCIATE PROGRAMS Durham Technical Community College

Revised 03/14/2011

CLINICAL TRIALS RESEARCH ASSOCIATE PROGRAMS

The Clinical Trials Research Associate (CTRA) program prepares individuals to assist physicians and clinical researchers in the initiation, administration, coordination, and management of clinical research studies for the development of new drugs, devices, biologics, or treatment regimens. During the program, the student will obtain theoretical knowledge in basic product development, federal regulations, good clinical practice, and the processes necessary to conduct a clinical research study. Through direct experience in a research setting, the student will apply this knowledge in a variety of ways such as in the recruitment and enrollment of human subjects, the compliance of the clinical site to regulatory requirements, the accountability and dispensation of investigational product, and the appropriate documentation of human subject involvement in a clinical research study.

Graduates will meet the educational requirements needed toward one of several national certification examinations. After graduation, employment opportunities may include medical centers, hospitals, pharmaceutical companies, clinics, research facilities, biotech/device companies, or physician offices.

The Associate Degree program is offered in two formats. The part-time EVENING/ONLINE program begins each fall semester. In this format, students can enroll in traditional CTR classroom courses or in online courses. The spring semester program is offered as a part-time DAY/HYBRID program. In this format, students attend a traditional class in the afternoon with required online assignments.

Three certificate programs, Clinical Research—Level I Option, Clinical Research—Level II Option, and Clinical Research Data Management, are offered for professionals who have current or prior work experience in the clinical research field or have a recent undergraduate or graduate degree in science.

How to Qualify for the CTRA Associate in Applied Science Degree Program

(begins fall or spring semester)

**NOTE: Refer to the admissions checklist available on the DTCC website. 1. Complete and return the college admissions enrollment application.

2. Complete and return the Clinical Training Form and Essential Skills (the last page of this packet).

3. Have an official high school transcript or GED scores sent directly to the Admissions Office at Durham Tech. Note: Applicants who document completion of a 2-year or 4-year college degree will not be required to submit a high school transcript.

5. Take the COMPASS placement test in Writing, Reading, Pre-Algebra and Algebra. The placement test is required for all CTRA degree applicants. (SAT scores of 500 Writing, 500 Reading, and 500 Math or ACT scores of 20 English and 20 Math taken within the last five years will waive the placement tests. No other exemptions from testing are given.)

Students who do not achieve the required score on one or more portions of the test must complete prescribed developmental courses in English, reading and math with a grade of “B” or better, and “C” or better for elementary algebra (MAT 070). IMPORTANT: Developmental courses may be used for three years to qualify for the CTRA program. Courses older than three years may be eligible if the student has been in continuous enrollment since completing the developmental course sequence. Developmental courses taken at other community colleges prior to Fall 2007 cannot be used to satisfy developmental prerequisites for this program.

6. Complete prerequisite biology and chemistry courses. This requirement may be satisfied by completing any of the following:

• High school biology and chemistry courses (one high school unit each) taken within ten years by the time a student achieves the required scores on the placement test OR completes all required developmental courses. Documented courses must be completed with a “C” (numerical value 77) or better grade.

• Pre-college level biology and chemistry courses taken at a community college (ex. BIO 092 and CHM 094 at Durham Tech) with no time limit. Documented courses must be completed with a “C” or better grade.

• College-level biology and chemistry courses (ex. BIO 111 and CHM 131/131A at Durham Tech) with no time limit. Documented courses must be completed with a “C” or better grade.

• CHM 130 and CHM 130A taken at Durham Technical Community College (beginning Fall 2009, this course will count for both the Biology and Chemistry requirement).

• An undergraduate or graduate degree in a biological science, chemistry, or allied health area with no time limit.

7. Students who hold an immigration visa, a permanent residence card, or have a transcript from a non-U.S. institution, will be required to show valid immigration

documents before being considered for admission.

9. All students entering a Health Technologies program must complete the “English Language Requirement Form” (available on the website) to demonstrate their language abilities. For students who meet the definition of “non-native speaker” (see English Language Requirement), they may be required to complete COMPASS ESL/Versant or complete the TOEFL test and submit the scores to the CTRA admissions counselor. 10. Students must demonstrate computer competency by achieving a satisfactory score on

the computer competency test; credit by exam; completion of CIS 110; or by other institutional transferable credit (comparable / higher level computer course).

NOTE: Prior to starting the degree program, students must obtain a Criminal Background Check from the company contracted through Durham Tech. Prior to starting fieldwork classes, students must complete the North Carolina Standard Allied Health Student Medical Form. Forms will be given to students at the appropriate time; do not obtain a criminal background check until instructed to do so.

How to Qualify for the CTRA Certificate Programs

Level I, Level II or Data Management

**NOTE: Refer to the admissions checklist available on the DTCC website. 1. Complete and return the admissions enrollment application.

2. Complete and return the Clinical Training Form (the last page of this packet).

3. Have an official high school transcript or GED scores sent directly to the Admissions Office at Durham Tech. Note: Applicants who document completion of a 2-year or 4-year college degree will not be required to submit a high school transcript.

4. If applicable, have an official transcript of previous college work sent directly to the Admissions Office at Durham Tech for possible transfer credit.

9. Document successful completion (“C” or better grade) of a college-level English (taken at a U.S. college or university) and/or math course OR take the COMPASS placement test in Writing, Reading, Pre-Algebra and Algebra. (SAT scores of 500 Writing, 500 Reading, and 500 Math or ACT scores of 20 English and 20 Math taken within the last five years will waive the placement tests. No other exemptions from testing are given.)

Students who do not achieve the required score on one or more portions of the test must complete prescribed developmental courses in English, reading and math with a grade of “B” or better, and “C” or better for elementary algebra (MAT 070). IMPORTANT: Developmental courses may be used for three years to qualify for the CTRA program. Courses older than three years may be eligible if the student has been in continuous enrollment since completing the developmental course sequence. Developmental courses taken at other community colleges prior to Fall 2007 cannot be used to satisfy developmental prerequisites for this program.

transcript from a non-U.S. institution, will be required to show valid immigration documents before being considered for admission.

7. All students must complete the “English Language Requirement Form” (available on the DTCC website or from your advisor) and submit to the admissions office.

8. All students entering a Health Technologies program must complete the “English Language Requirement Form” (available on the website) to demonstrate their language abilities. For students who meet the definition of “non-native speaker” (see English Language Requirement), they may be required to complete COMPASS ESL/Versant or complete the TOEFL test and submit the scores to the CTRA admissions counselor. 9. Students must demonstrate computer competency by achieving a satisfactory score on the

computer competency test; credit by exam; completion of CIS 110; or by other institutional transferable credit (comparable / higher level computer course).

10. Additional admissions requirements for certificate programs

:

Clinical Research—Level I (begins fall and spring semesters)

A. Submit a letter—on official company letterhead—from a current and/or previous employer documenting at job responsibilities and at least ONE year of employment in the clinical research field within the past five years.

OR

B. Submit an official college transcript that indicates an undergraduate (BS) or graduate degree in a biological science, chemistry, or healthcare/allied health occupation that involves current employment in clinical practice and/or involving direct patient care.

NOTE: An AAS in nursing will also be accepted. Clinical Research—Level II (begins fall and spring semesters)

A. Submit a letter—on official company letterhead—from a current and/or previous employer documenting job responsibilities and at least TWO years of employment in the clinical research field within the past five years.

OR

Document completion of the CTRA Level I certificate (NOTE: the final semester of Level I and the first semester of Level II will overlap)

Clinical Research Data Management (begins summer term)

OR

Submit an official college transcript that indicates an undergraduate (BS) or graduate degree in a biological science, chemistry, or healthcare occupation involving clinical practice and/or patient care OR in a computer science area.

OR

Document completion of the CTRA Level I certificate

* * * * * * * * * * * * * * * *

Program Orientation

A mandatory program orientation is held prior to (or during) the first week of class each year. Students who do not attend orientation will be dropped from the program.

Students taking the first course, CTR110 in an online format must also attend a mandatory orientation for online courses. This session is held on campus during the week prior to class start.

* * * * * * * * * * * * * * * * DIFFERENT LEVELS OF ACCEPTANCE

Students who submit a transcript showing graduation from either a high school or a college will initially be accepted into the Clinical Trials Preparatory Program. Upon completion of all other admissions requirements for the chosen program, the student will be admitted into either the degree program or one of the certificate programs only if there is a space available. Students will not be allowed to take CTR courses until all admissions requirements are met.

Because the degree and certificate programs have a limited number of spaces each year, applicants are encouraged to complete all admissions requirements as soon as possible. If the number of students qualifying for the program exceeds the number of spaces available, a waiting list will be started. Admission to the program will be on a “first come, first served” basis, in the order in which students have completed all admissions steps and developmental courses, and are ready to enter the program. Waiting list students are encouraged to enroll in other courses in the program. In other words, students who are not yet admitted to the program and are on the waiting list, may start taking general education courses such as ENG 111, PHI 240, etc.

If you have questions about the CTRA degree or certificate programs, please contact the CTRA Program Admissions Counselor, Johanna Brown, M. Ed., Ph.D.: [email protected] 919-536-7202 x1104.

Sign and return this form to:

Admissions Office Durham Technical Community College 1637 Lawson St. Durham, NC 27703

Statement of Policy Regarding Acceptance for Clinical Training in the Following Programs at Durham Technical Community College Associate Degree Nursing Medical Assisting

Clinical Trials Research Associate Practical Nursing Occupational Therapy Assistant Respiratory Therapy Pharmacy Technology Surgical Technology

Students accepted into the above programs must meet the standards of both the College and the affiliated clinical sites in order to participate in the appropriate clinical training for the program. Each clinical site where a student receives training reserves the right to refuse clinical training to any student found to be unacceptable according to that site’s policies and regulations. Clinical sites require a Criminal

Background Check prior to the student’s placement for training at that site. Reasons for refusal

could include, among other considerations, a documented criminal background check indicating convictions for drug or alcohol related charges, child abuse or molestation, burglary, larceny, or other convictions deemed inappropriate to the particular clinical setting. In addition, students may be required to submit to drug testing per the clinical site’s requirement.

The student must conform to and be subject to all policies and regulations of the assigned clinical site. The site reserves the right to end clinical training of any student whose performance violates rules, policies, procedures or professional standards expected by the agency. Written justification from the clinical site will be provided to the College for such suspension. The clinical site and college personnel reserve the right to take appropriate immediate action, when necessary, to maintain the proper and safe operation of its facilities and the safety of clients in the clinical setting.

Criminal Background Check: A Criminal Background Check form will be sent to students at the time

they are accepted into the clinical portion of their health program. The background check will include reports from all states where the student has lived within the past ten (10) years or from the date that the student turned eighteen (18) years of age, whichever is shorter. Students will pay a fee directly to a

designated vendor for this background check.

Additional information on the Criminal Background Check requirement may be obtained from the Durham Tech website: www.durhamtech.edu

I verify that I have read and fully understand the Statement of Policy Regarding Acceptance for Clinical Training at Durham Technical Community College. I also understand that a criminal background check and/or drug testing will be required for placement in clinical training sites for Durham Technical Community College.

CLINICAL TRIALS RESEARCH ASSOCIATE PROGRAM ESSENTIAL SKILLS FOR ADMISSION AND PROGRESSION

PHYSICAL AND PSYCHOLOGICAL REQUIREMENTS

Students applying to the CTRA program must demonstrate sufficient physical and emotional health to be considered fit to participate in academic education and laboratory experiences, and to practice clinically with clinical research professionals and the public in a safe and effective manner.

ISSUE STANDARD EXAMPLES OF NECESSARY ACTIVITIES (not

inclusive)

CRITICAL THINKING

Critical thinking ability sufficient for problem solving and clinical judgment.

• Identify cause and effect relationships in clinical situations • Consider human research subject (participant) protection

requirements and risks to research participants • Balance and manage multiple priorities • Make effective decisions quickly READING AND

LISTENING SKILLS

Reading and listening abilities sufficient to fully understand required activities.

• Read, understand, and follow written and verbal instructions to complete assigned activities and tasks

• Read, understand, and adhere to all project activity due dates • Exhibit the ability to organize multiple assigned tasks and

posted deliverable dates INTERPERSONAL

SKILLS

Interpersonal abilities sufficient to interact appropriately with Sponsors, Principal Investigators, research site personnel, and contract research organization personnel

• Establish rapport with clients, research participants & colleagues

• Cope effectively with stress in the workplace

• Cope with client, research participant & colleague emotions calmly

• Demonstrate a high degree of patience and compassion COMMUNICATION

Communication abilities sufficient for professional oral & written interactions.

• Give formal/informal reports on research trial progress • Provide study specific training and education

• Conduct interviews, in-services, and meetings MOBILITY

Physical abilities sufficient to move throughout facilities & within small spaces to carry out responsibilities of job

• Move around efficiently in offices and research sites • Reach above head, lift, push, pull binders and other study

supplies up to 10 lbs each

• Ability to travel via airplane and ground transportation and maneuver luggage

MOTOR SKILLS

Gross & fine motor abilities sufficient to carry out responsibilities of job

• Handle/use paper and/or electronic documents and use assessment instruments

• Inventory investigational product HEARING

Auditory ability sufficient to monitor & assess

client/colleague/subject needs and maintain facility safety.

• Hear alarms, emergency signals, auscultatory sounds & cries for help

• Hear and respond appropriately to verbal communication

VISION

Visual ability sufficient for

observation & assessment • Observe client/colleague/subject responses _{• Read assessment instruments}

• Read computer based applications including electronic files and electronic data systems

EMOTIONAL

Emotional stability sufficient to maintain composure in stressful situations.

• Interact appropriately with peers, clients & supervisors at all times, including in high stress situations

• Receive corrective feedback calmly ENVIRONMENTAL

Ability to tolerate environmental stressors.

• Adapt to variations in work schedule • Work in areas that are close or crowded

• Work in high stress environments with client centered work and time sensitive deliverables.

I certify that I have read the Essential Skills for Admission and Progression form. I certify that I understand the physical and psychological requirements for clinical research professionals. I have assessed my ability to perform these skills and am able to demonstrate these essential skills.

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