PHSC 323 – General Biochemistry
Credit: 3 hours
A comprehensive course in biochemistry which presents protein, lipid and nucleic acid biosynthesis and catabolism. Principles of enzyme kinetics, regulation, energy metabolism, signal transduction and macromolecular structure-function relationships are presented. It is recommended that a student take Microbiology or Cell Biology before taking this course.
Prerequisite: Organic Chemistry I-II;
Co-requisite: PHSC 220/220L, PHSC 325/325L
PHSC 325/325L – General Biochemistry Pre-Lab/Lab
Credit: 1 hour
This course is intended to provide the student with the experience working with basic techniques used in the study of bio-molecules, particularly proteins. Students will gain knowledge of protein characterization techniques, such as: gel filtration, enzyme kinetics, PAGE, ELISA. A detailed laboratory notebook will be used to document all lab work and its contents will assist with the written reports. An end of the semester lab practical is given as well. Students must attend a weekly pre-lab session.
Co-requisite: PHSC 323
PHSC 328 – Introduction to Pharmacology
Credit: 4 hours
The basic principles of drug action are covered through discussion of the responses of biological systems to drugs and chemicals. Emphasis is place on understanding mechanism of action through detailed exploration of receptor-mediated events (pharmacodynamics). The course considers the quantification of drug action as well as the absorption, distribution, metabolism, and elimination of xenobiotics (pharmacokinetics) and how these and other factors relate to drug action.
Prerequisites: Must complete 2 groups of prerequisites for this course: 1) CHEM 227/228, & 2) Either BIOL 221 or BIOL
285/286. Must be completed prior to taking this course. Students with other qualifications may enroll with permission from the course director.
CLNR 324 – Introduction to Biostatistics
Credit: 3 hours
This course, focused on statistical methods in health sciences, is intended to provide students with a basic knowledge of descriptive statistics, graphing data, probability theory, normal and other common distributions, sampling and estimation, confidence intervals, hypothesis testing, ANOVA, and other selected statistical methods.
CLNR 338 – Scientific Literature Seminar
Credit: 2 hours
This interactive class introduces students to literature searching and critical analysis techniques. Skills in critical analysis of the scientific literature will be developed in small group discussion of scientific papers chosen by the faculty and students. These skills are applied in the form of written and oral presentations of projects developed by researching the current clinical research literature. In addition to learning how to apply these skills with a team, complete comprehension of these skills are applied in the form of oral presentations.
CLNR 340 – Regulatory Affairs
Credit: 3 hours
This course provides the student with an overview of regulatory affairs, with emphasis on requirements for initiating clinical trials, developing pharmaceutical products, and gaining approval for worldwide marketing applications. The course will include discussion of data submission requirements, quality procedure regulations, and marketing considerations. Practical exercises will be representative of tasks assigned to employees seeking entry level positions within the industry.
CLNR 341 – Medical Terminology (Online)
Credit: 2 hours
This course is designed to introduce students to the language of the clinical research and medical communities. Instruction will engage students and provide them an opportunity to learn, understand, and apply the terminology in context of clinical research and medical settings.
CLNR 345 – Clinical Study Operations
Credit: 2 hours
This course will provide students with an overview of clinical study operations, including but not limited to site selection & evaluation, trial management, and clinical trial management systems, Trial Master File, recruitment, audits, reporting, and financial negotiations. The knowledge and skills obtained within the course will prepare students for entry-level positions for clinical study operations.
Prerequisites: CLNR 364
CLNR 364 – Principles of Clinical Research
Credit: 2 hours
This course will provide a basic understanding of clinical research including purpose, terminology, and methodology. The course will explore basic elements of clinical research including such topics as study design, data management, conduct, and the various roles of those involved in the industry.
CLNR 412 – Senior Pre-Internship Seminar
Credit: 1 hour
This course is designed to allow students to plan and prepare for the experiential learning opportunity provided as part of the required curriculum. During this course, students will complete all documents required by internship sites. Students and participating internship sites will be matched to ensure a comprehensive work experience is obtained when the student proceeds with internship.
Prerequisites: Proper progression for BSCR curriculum and on track for senior internship in next semester offered.
CLNR 415 – New Product Development
Credit: 2 hours
This course is designed to focus on the processes of bringing a new drug molecule into clinical practice. The course will encompass aspects of discovery, finding suitable molecular targets, clinical development, to the commercial launch of a new drug product. The course considers the dynamics of regulatory affairs, advances in technology, and scientific methodologies and their respective impact on new product development to meet un- met medical needs. This course draws upon the prior curriculum and provides further practical and contemporary application. The knowledge and skills obtained within the course will prepare students for the variety of roles in the clinical research industry and how the roles contribute to the availability of new products.
Prerequisites: CLNR 340 & CLNR 364
CLNR 416 – Senior Seminar
Credit: 3 hours
This course is designed to prepare the student for real world practices. The student will learn and review research, presentation and public speaking techniques and utilize these to prepare a research paper and presentation. This course culminates in a presentation day where each student will present their research information and internship experience to the Department of Clinical Research and honored guests.
Prerequisites: All CLNR courses Co-requisites: CLNR 420
Fall/Spring semesters only (BSCR students)
CLNR 420 – Senior Internship
Credit: 12 hours
This course is an experiential learning system, which allows the BSCR students an opportunity to gain hands on experience in the clinical research profession. Students and participating institutions are matched to pro- vide a comprehensive work experience. The internship is designed for a BSCR candidate to develop strong clinical research skills while improving his/her knowledge in the field of clinical research.
Prerequisites: Completion of all GCC & BSCR courses and at least a 2.0 major and cumulative GPA
Co-requisites: CLNR 416
CLNR 425 – Medical Ethics in Clinical Research
Credit: 2 hours
This course provides a review of past medical and research historical events that have shaped the ethical standards in clinical research. Students in this course will analyze and discuss recent medical ethics cases on special topics including current events as appropriate.
Prerequisites: Appropriate progression through the BSCR curriculum
CLNR 440 – Regulatory Affairs II
Credit: 2 hours
This course builds upon concepts developed in Regulatory Affairs I and provides more de- tailed and broader coverage of the terminology and concepts that address the regulation of the pharmaceutical industry by the Food and Drug Administration, with an emphasis on the drug, biologic, and veterinary product development and approval process.
Prerequisites: CLNR 330
CLNR 442 – Interpersonal Skills & Critical Thinking
Credit: 2 hours
Interpersonal skills are soft skills that one uses every day to interact with and relate to other people. Those with strong interpersonal skills are usually more successful in both their professional and personal lives. Critical thinking brings conscious awareness, skills, and standards to the process of observing, analyzing, reasoning, evaluating, reading, and communicating. This course will teach students how to develop interpersonal skills and become effective at listening, communicating, and working within a team. Additionally, students will learn how to write a professional resume and cover letter, as well as how to prepare for future interviews. This course will also teach the application of the principles of critical thinking.
CLNR 445 – Research Site Operations
Credit: 2 hours
This course is designed to focus on clinical operations from the site perspective. The course will include but is not limited to assessing patient eligibility, understanding the consent process, assessing, and grading adverse events, and handling deviations through root cause analysis and developing corrective and preventative action plans. Students will also be introduced to the basic principles of history taking and basic techniques of physical examination assessments as it pertains to clinical research. The knowledge and skills obtained within the course will prepare students for clinical research assistant and coordinator positions at the site level.
Prerequisites: CLNR 341 & CLNR 364
CLNR 450 – Data Management
Credit: 3 hours
This introductory course covers topics such as the role of data management in clinical trials and the duties of the Clinical Data Coordinator. Topics include organization, col- lection, review, and tracking of data. Coding of data and standardized terminology are also considered. The course will also include instruction on using Excel, SAS, and implemented a survey using modern electronic data collection methods.
Prerequisites: CLNR 364
CLNR 451 – Scientific & Technical Writing
Credit: 2 hours
Scientific and Technical Writing is a required course for Clinical Research majors designed to enable students to become more effective writers and literature evaluators. Students will focus on the format and customs of scientific writing, ethics of writing and use of reference management software. Focus will be on confidently and accurately producing written scholarly documents related to clinical research.
Prerequisites: CLNR 338
CLNR 455 – Managing & Monitoring Clinical Trials
Credit: 2 hours
This course provides both a theoretical and practical overview of the principles of man- aging and monitoring clinical trials. The focus will be on the role of the Clinical Research Associate (CRA) and Central Monitoring Associate, which will include activities centered on alternative monitoring strategies currently in use. Discussion topics will consist of reduced source document verification (SDV), remote monitoring, central monitoring, risk-based monitoring, triggered/target monitoring, and site-based monitoring of clinical trials.
Prerequisites: CLNR 345
CLNR 465 – Managing & Monitoring Clinical Trials II
Credit: 2 hours
This course will continue to build upon concepts introduced and developed in CLNR 365, Managing and Monitoring Clinical Trials
- Additional material will be added as appropriate, and students will achieve a greater depth of knowledge and understanding about topics covered in the first course. Prerequisites: CLNR 365