2020 - 2021
Florida Department of Education
Curriculum Framework 

Program Title:	Clinical Research Coordinator
Career Cluster:	Health Science

CCC	
CIP Number	0351071901	
Program Type	College Credit Certificate (CCC)	
Standard Length	30 credit hours	
CTSO	HOSA	
SOC Codes (all applicable) 	11-9121 Natural Science Managers
11-9199 Manager, All Other
11-9111 Medical and Health Services Manager
31-9099 Healthcare Support Worker, All Other	
CTE Program Resources 	http://www.fldoe.org/academics/career-adult-edu/career-tech-edu/program-resources.stml 	

Purpose

This certificate program is part of the Clinical Research Professional AS or AAS degree program (1351071902).  

A College Credit Certificate consists of a program of instruction of less than sixty (60) credits of college-level courses, which is part of an AS or AAS degree program and prepares students for entry into employment (Rule 6A-14.030, F.A.C.).

This program offers a sequence of courses that provides coherent and rigorous content aligned with challenging academic standards and relevant technical knowledge and skills needed to prepare for further education and careers in the Health Science career cluster; provides technical skill proficiency, and includes competency-based applied learning that contributes to the academic knowledge, higher-order reasoning and problem-solving skills, work attitudes, general employability skills, technical skills, and occupation-specific skills, and knowledge of all aspects of Health Science career cluster. 

The purpose of this program is to prepare students for employment as clinical research coordinators. SOC Code 11-9121 (Natural Science Manager), 11-9111 (Medical and Health Services Manager), 11-9199 (Manager All Other), or 31-9099 (Healthcare Support Workers, All other) or to provide supplemental training for persons previously or currently employed in these occupations.  

The content includes but is not limited to communication skills, leadership skills, human relations and employability skills, principles of management, introduction to computer literacy, health care organization, medical ethics, legal aspects, and advanced technical skills in a chosen health-related profession, health and safety, and CPR.

Additional Information relevant to this Career and Technical Education (CTE) program is provided at the end of this document.

Program Structure

This program is a planned sequence of instruction consisting of 30 credit hours.

Standards

After successfully completing this program, the student will be able to perform the following:

01.0	Demonstrate basic knowledge of medical language, anatomy and physiology. 
02.0	Identify and apply basic knowledge of different aspects of wellness.  
03.0	Demonstrate knowledge of funding and site sponsorship related to clinical research including: public/private grants and contracts and lifecycles of clinical trials.
04.0	Demonstrate knowledge of the guidelines and regulations governing clinical trials.
05.0	Demonstrate ability to work as a clinical research professional.
06.0	Demonstrate knowledge of the compliance and monitoring issues in clinical research.
07.0	Demonstrate knowledge of the research process including: consent, screening, phases of clinical trials, product development and adverse events and safety.
08.0	Demonstrate knowledge of current events in the field of public health.
09.0	Demonstrate the ability to identify U.S. health care delivery funding sources.
10.0	Demonstrate knowledge of the principles and language of pharmacology, including drugs and drug classes, diagnostic tests, indications, techniques.

2020 - 2021
Florida Department of Education
Student Performance Standards

Program Title:	Clinical Research Coordinator
CIP Number:		0351071901
Program Length:	30 credit hours
SOC Code(s):	  	11-9121, 11-9111, 11-9199, 31-9099

This certificate program is part of the Clinical Research Professional AS degree program (1351071902).  At the completion of this program, the student will be able to:	
01.0	Demonstrate basic knowledge of medical language, anatomy and physiology. – The student will be able to:	
01.01	Define, describe and discuss anatomic descriptive terms of the body.	
01.02	Demonstrate an understanding of basic patient discharge and transfer procedures.	
01.03	Describe common abbreviations and commonly used medical terms and their proper usage.	
01.04	Define and describe anatomic names of bones and organs of the body.	
02.0	Identify and apply basic knowledge of different aspects of wellness.  – The student will be able to:	
02.01	Discuss integrating health living into one’s lifestyle.	
02.02	Define: physical fitness, mental health, nutrition, tobacco usage, alcohol consumption, illicit drug use, family living and how these factors connect with the concepts of wellness on a personal level.	
02.03	Identify the risk factors for cardiovascular disease.	
02.04	Describe the effects of tobacco and smoking on the human body.	
02.05	Describe the various fitness methods to improve health.	
02.06	Discuss the effects of nutrition on health and wellness.	
02.07	Explain body composition and achieving a healthy weight.	
02.08	Describe stress management strategies.	
02.09	Discuss the use and abuse of illicit drugs in society.	
02.10	Describe the effects of chronic disease on the human body.	
03.0	Demonstrate knowledge of funding and site sponsorship related to clinical research including: public/private grants and contracts  and lifecycles of clinical trials.– The student will be able to:	
03.01	Describe key concepts and skills used in the site-sponsor relationship.	
03.02	Classify clinical research funding sources and the protocols used to secure funding.	
03.03	Discuss basic constructs related to grants & contracts management in clinical research.	
03.04	Provide examples of the types of lifecycles of clinical trials.	
03.05	Define the terms and language used in startup & closing Items on clinical research.	
03.06	Determine communication methods to be used in the startup and closing of items in clinical research.	
04.0	Demonstrate knowledge of the guidelines and regulations governing clinical trials.– The student will be able to:	
04.01	Understand the array of guidelines & regulations governing clinical trials.	
04.02	Describe the various HIPPAA Privacy & clinical research privacy issues.	
04.03	Identify the major GCP/ICH guidelines related to working with human subjects in research.	
04.04	Discuss the various sources and uses of essential documents generated from clinical studies.	
04.05	Explain the role of compliance in maintaining fidelity to a study protocol.	
04.06	Provide examples of a standard response to a request for documentation of meeting award conditions.	
04.07	Understand the array of analysis techniques used in interpreting research findings.	
05.0	   Demonstrate ability to work as a clinical research professional.– The student will be able to:	
05.01	Identify clinical and behavioral research settings where Clinical Research Professionals are employed.	
05.02	Demonstrate an understanding of the essential duties of a Clinical Research Professional.	
05.03	Describe procedures and processes used to protect research participants at placement site.  	
05.04	Discuss the core research activities of placement site.	
05.05	Demonstrate an understanding of how placement site works with: local, county, state and federal agencies to carry out their research activities.  	
05.06	Evaluate the role of Clinical Research Professionals in research settings.	
05.07	Demonstrate the skills necessary to be a productive member of a research team including; working on a multidisciplinary research team and demonstrating an ability to work with confidential research participant information.	
06.0	   Demonstrate knowledge of the compliance and monitoring issues in clinical research.– The student will be able to:	
06.01	Describe the role of compliance in clinical research.	
06.02	Identify issues related to compliance in human subject’s research.	
06.03	Explain activities associated with monitoring within the scope of clinical research.	
06.04	Discuss processes used to resolve issues that may arise from monitoring as part of a clinical trial.	
06.05	Provide examples of quality assurance audits used in clinical research and discuss their value in relation to performing research with human subjects.	
06.06	Define the types of inspections clinical research facilities are subject to.	
07.0	   Demonstrate knowledge of the research process including: consent, screening, phases of clinical trials, product development and adverse events and safety.– The student will be able to:	
07.01	Accurately describe the processes involved in clinical research.	
07.02	Define and describe issues associated with participant consent.	
07.03	Explain the goals, limitations and basic rules for screening participants.	
07.04	Discuss market and social aspects of product development (drugs & devices).	
07.05	Discuss impacts of clinical trial stakeholders.	
07.06	Accurately describe how epidemiology is used in clinical research.	
07.07	Explain the relationship between essential processes related to adverse events & safety.	
08.0	Demonstrate knowledge of current events in the field of public health. – The student will be able to:	
08.01	Identify outlets (news, media, governmental) used to communicate public health events to the general public.	
08.02	Describe the implications of current events on public health.	
08.03	Discuss concerns related to how public health information is relayed to the public.	
08.04	Recognize how reporting of global events (e.g. epidemics, regime change, and weather events) has the potential to impact other areas.	
08.05	Locate emerging public health trends.	
08.06	Explain etiology of emerging public health trends discussed throughout semester.	
08.07	Discuss legislation designed to protect the public’s right to information during major health events (epidemics, terrorism, natural disasters).	
09.0	Demonstrate the ability to identify U.S. health care delivery funding sources. – The student will be able to:	
09.01	Demonstrate an understanding of the evolutionary perspective of health services and its relevance with the existing healthcare system, facilities and services.	
09.02	Explain the social, political, and public policy implications of health-related issues, such as availability, cost, delivery, and financing.	
09.03	Describe the various health care organizations and service delivery options.	
09.04	Identify the major health professions and explain the role of each and their licensing/educational requirements.	
09.05	Compare and contrast the health care delivery systems of the U.S. with other major industrialized nations.	
09.06	Understand the array of career choices in the health care sector of the economy.	
10.0	Demonstrate knowledge of the principles and language of pharmacology, including drugs and drug classes, diagnostic tests,    indications, techniques.-The student will be able to:	
10.01	Describe pharmacological principles.
	
10.02	Classify routes of administration.
	
10.03	Describe the relationships of drug classes with disease processes and medical specialties.
	
10.04	Recognize commonly prescribed medications.	
10.05	Use appropriate pharmacological and laboratory references.
	
10.06	Describe indications, actions, dosages, and routes of administration.	

Additional Information

Laboratory Activities

Laboratory investigations that include scientific inquiry, research, measurement, problem solving, emerging technologies, tools and equipment, as well as, experimental, quality, and safety procedures are an integral part of this career and technical program/course. Laboratory investigations benefit all students by developing an understanding of the complexity and ambiguity of empirical work, as well as the skills required to manage, operate, calibrate and troubleshoot equipment/tools used to make observations. Students understand measurement error; and have the skills to aggregate, interpret, and present the resulting data. Equipment and supplies should be provided to enhance hands-on experiences for students.

Career and Technical Student Organization (CTSO)

HOSA is/are the intercurricular career and technical student organization(s) providing leadership training and reinforcing specific career and technical skills. Career and Technical Student Organizations provide activities for students as an integral part of the instruction offered. 

Accommodations

Federal and state legislation requires the provision of accommodations for students with disabilities to meet individual needs and ensure equal access. Postsecondary students with disabilities must self-identify, present documentation, request accommodations if needed, and develop a plan with their counselor and/or instructors. Accommodations received in postsecondary education may differ from those received in secondary education. Accommodations change the way the student is instructed. Students with disabilities may need accommodations in such areas as instructional methods and materials, assignments and assessments, time demands and schedules, learning environment, assistive technology and special communication systems. Documentation of the accommodations requested and provided should be maintained in a confidential file.

Additional Resources

For additional information regarding articulation agreements, Bright Futures Scholarships, Fine Arts/Practical Arts Credit and Equivalent Mathematics and Equally Rigorous Science Courses please refer to:
http://www.fldoe.org/academics/career-adult-edu/career-tech-edu/program-resources.stml