Clinical Research Program
Certificate of Mastery
Minimum of 21 credit hours
If you’re interested in working with doctors, research nurses and clinical research coordinators to perform studies involving research participants, then the clinical research program at Oklahoma City Community College is for you. At OCCC, you can earn an associate degree in applied science or a certificate of mastery in clinical research; the certificate of mastery is a quick turn-around program that gets you trained, out-the-door and into the job market. The work you do in clinical research varies from employer to employer but will likely include tasks such as recruiting participants, obtaining informed consent, collecting participant data, entering that data and managing clinical research projects. The clinical research projects themselves are also varied and can range from clinical trials for new chemotherapy drugs, lupus medications, rheumatoid arthritis treatments and diabetes treatments to testing medical devices such as ventricular heart valves and new materials for wound healing. You must apply for admission to the clinical research program after being accepted for admission to OCCC. All program applications are reviewed by a selection committee.
- Course Sequence
Course ID Course name Credits Type Min Gd Suggested Freshman 1st Semester CRC 1103 INTRODUCTION TO CLINICAL RESEARCH 3 Major Suggested Freshman 2nd Semester CRC 1203 MEDICAL ETHICS AND CLIENT CARE 3 Major CRC 1303 CLINICAL TRIALS AND RESEARCH REGULATIONS 3 Major Suggested Sophomore 1st Semester CRC 2003 CLINICAL DATABASE APPLICATIONS 3 Major CRC 2103 CLINICAL RESEARCH DESIGN 3 Major Suggested Sophomore 2nd Semester CRC 2113 CLINICAL RESEARCH SITE MANAGEMENT 3 Major CRC 2313 CLINICAL PROTOCOL DESIGN 3 Major
- Course Grouping
Major Courses: (21 credit hours) Clinical Research Coordinator: CRC 1103, CRC 1203, CRC 1303, CRC 2103, CRC 2003, CRC 2113, CRC 2313;
General Education Courses: None
Life Skills Courses: None
Support Courses: None
- Program Notes
Notes: A Certificate of Mastery program is designed to meet the needs of an individual who wants to enter the job market following the completion of the certificate.
- Course Descriptions
Clinical Research Coordinator
CRC 1103 - INTRODUCTION TO CLINICAL RESEARCH
Prerequisites: ENGL 0203, adequate placement score, or by meeting determined placement measures
The student will demonstrate knowledge of the history of human subject research, evolution of rules protecting human subjects, roles of the clinical research teams, clinical trial phases, and responsibilities of clinical research organizations.
CRC 1203 - MEDICAL ETHICS AND CLIENT CARE
Prerequisites: CRC 1103
The student will be able to describe the fundamentals of ethical principles involving human research subjects, understand informed consent and the role of the Internal Review Board, and identify vulnerable populations.
CRC 1303 - CLINICAL TRIALS AND RESEARCH REGULATIONS
Prerequisites: CRC 1103
The student will receive and overview of federal and international guidelines governing clinical research and drug trials, including Good Clinical Practices and International Council on Harmonization guidelines. An emphasis will be placed on understanding of research organization compliance, responsibilities of the Internal Review Board and the Health Insurance Portability and Accountability Act (HIPAA). The student will identify and complete required regulatory forms, define human subject protection guidelines, compare federal versus international guidelines for clinical research and discuss conflict of interest issues.
CRC 2003 - CLINICAL DATABASE APPLICATIONS
Prerequisites: CRC 1103
The student will demonstrate mastery of the concepts of clinical research data management systems, quality assurance, data confidentiality and security, accurate preparation of case reports.
CRC 2103 - CLINICAL RESEARCH DESIGN
Prerequisites: CRC 1203; CRC 1303
Students will acquire a basic knowledge of research design methodologies, data organization and presentation, participant eligibility, adverse event documentation, site visit and audit preparation, and budget design.
CRC 2113 - CLINICAL RESEARCH SITE MANAGEMENT
Prerequisites: CRC 2103
The student will acquire a basic knowledge of research site organization, operation and management. The student will be learn the process involved in grant applications, study initiation, documentation requirements, and site evaluations. Emphasis will be placed on defining process flow and interactions with Institutional Review Boards, sponsors, regulators, investigators, and the community.
CRC 2313 - CLINICAL PROTOCOL DESIGN
Prerequisites: CRC 2103; CRC 2113
Through study, discussion, and classroom activities the student will identify different research designs, master the rules for writing protocols, understand ethical issues involved in research protocol design, and develop the skills to design data collection forms.