Clinical Trial Proficiency Certificate
Description:
The Clinical Trial proficiency certificate provides students with the comprehensive knowledge, core competencies, and skills necessary for employment in the rapidly expanding field of clinical research in academia, and the pharmaceutical and biotechnology industries. Through classroom and hands-on learning, students learn about the fundamentals of drug development, clinical trial design, research ethics, regulatory compliance, and data collection/analysis and management. Students are prepared to become CITI and HIPAA certified, which is required for the Protection of Human Research Subjects, and other credentialing assessments from organizations such as the Society of Clinical Research Associates (SOCRA) and the Association of Clinical Research Professionals (ACRP). This proficiency certification significantly enhances students' career prospects, positioning them for success in the dynamic and expanding field of clinical research by improving their understanding of clinical research, as well as their technical, interpersonal, and business skills.
Program Learning Outcomes:
Upon completion of the Clinical Trial proficiency certificate, students will gain the following skills;
- Identify research processes and phases of clinical research development of drugs, devices and biologics.
- Practice clinical trial design and protocol development.
- Demonstrate adherence to ethical considerations and regulatory principles in the design, conduct, and analysis of clinical trials.
- Differentiate the roles and duties of clinical positions, as well as different organizations and agencies, as they pertain to conduction of the clinical research.
- Apply professional conduct and proficient technical, interpersonal, and business skills pertinent to clinical trial.
Program Entry Requirements:
Students currently enrolled in or who have already graduated with an AA or AS in Biological Science, as well as those in Nursing and Allied Health programs, can seamlessly complete the Clinical Trial certificate as part of a dual degree. For example, Nursing graduates or students who have already completed courses in pharmacology and statistics can obtain the certificate by simply taking the introduction to clinical trial course and an internship as electives. But this certificate is open to any interested student and individual from different disciplines. New students are normally required to take the College’s placement test at their time of entry. Students who are identified as needing developmental course work must satisfactorily complete the appropriate English and mathematics courses as part of the certificate.
Program of Study and Graduation Requirements:
Successful completion of the certificate requires a grade of "C" or better in all lecture courses and a passing grade in the internship. Achievement of a grade of "C" or better in all courses and passing the internship requires the student to demonstrate competency as assessed using written exams, quizzes, group projects, writing assignments and reports, presentations and participation in classroom and research activities.
Course Sequence:
| Course Number and Name | Prerequisites | Credits |
|---|---|---|
| MATH 150 - Introductory Data Analysis or higher or a replacement test. | FNMT 017 or FNMT 019 completed or placement in FNMT 118 or higher | 3 credits |
| BIOL 108 -Essentials of Human Anatomy & Physiology or BIOL 110 -Anatomy and Physiology II | BIOL 108 prereq: FNMT 118 or MATH 118 (or higher) placement BIOL 110 prereq: BIOL 109 | 4 credits |
| CHEM 203 - Basic Pharmacology or completing nursing program or a or a replacement test | BIOL 110 or BIOL 108 | 4 credits |
| CTR 101- Introduction to Clinical Trial | 4 credits | |
| CTR 201 - Clinical Trial Internship | CTR 101 | 4 credits |