2022 - 2023
Florida Department of Education
Curriculum Framework 

Program Title:	Clinical Research Professional
Career Cluster:	Health Science

AS	
CIP Number	1351071902	
Program Type	College Credit	
Standard Length	60 credit hours	
CTSO	HOSA	
SOC Codes (all applicable) 	11-9121  Natural Science Manager
11-9111  Medical and Health Services Manager
11-9199  Manager All Other
30-9099  Healthcare Support Workers, All Other	
CTE Program Resources 	http://www.fldoe.org/academics/career-adult-edu/career-tech-edu/program-resources.stml	

Purpose

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 60 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	Demonstrate knowledge of the major ethical theories in philosophy and how they relate to clinical care. 
03.0	Demonstrate knowledge of the use of scientific methods in examining society.
04.0	Demonstrate knowledge of modern scientific psychology and its application to human behavior.
05.0	Identify and apply basic knowledge of different aspects of wellness.  
06.0	Demonstrate knowledge of health communication and its impact on health outcomes.
07.0	Demonstrate knowledge of the three primary levels of prevention.
08.0	Demonstrate the use of evidence to draw conclusions about disease etiology.
09.0	Demonstrate knowledge of current events in the field of public health.
10.0	Demonstrate the ability to identify U.S. health care delivery funding sources.
11.0	Demonstrate knowledge of funding and site sponsorship related to clinical research including: public/private grants and contracts  and lifecycles of clinical trials
12.0	Demonstrate knowledge of the research process including: consent, screening, phases of clinical trials, product development and adverse events and safety
13.0	Demonstrate knowledge of the guidelines and regulations governing clinical trials.
14.0	Demonstrate ability to work as a clinical research professional.
15.0	Demonstrate knowledge of the compliance and monitoring issues in clinical research
16.0	Demonstrate knowledge of Institutional Review Board functions and operations including purpose, review types and composition. In addition, ethical issues within clinical research will be introduced.
17.0	Demonstrate knowledge of the principles and language of pharmacology, including drugs and drug classes, diagnostic tests, indications, techniques.

2022 - 2023
Florida Department of Education
Student Performance Standards

Program Title:	Clinical Research Professional
CIP Number:		1351071902
Program Length:	60 credit hours
SOC Code(s):	  	11-9121, 11-9111, 11-9199, 31-9099

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	Demonstrate knowledge of the major ethical theories in philosophy and how they relate to clinical research. – The student will be able to:	
02.01	Define ethical theories in philosophy and how they are used in evaluating contemporary issues in clinical care.	
02.02	Describe applications of ethical codes.	
02.03	Explain variations in ethical standards across health research settings.	
03.0	Demonstrate knowledge of the use of scientific methods in examining society. – The student will be able to:	
03.01	Define and discuss group structure.	
03.02	Define and discuss socialization, social stratification and social roles.	
03.03	Explain deviance, collective behavior, ethnic diversity and globalism.	
04.0	Demonstrate knowledge of modern scientific psychology and its application to human behavior. – The student will be able to:	
04.01	Discuss personality development.	
04.02	Define: perception, motivation, learning, thinking, and remembering.	
04.03	Describe how the scientific method is used in psychology.	
04.04	Explain emotion and how it impacts perception.	
04.05	Define intelligence and describe how it is measured.  	
04.06	Define cognition and how information is input, stored and retrieved.	
05.0	Identify and apply basic knowledge of different aspects of wellness.  – The student will be able to:	
05.01	Discuss integrating health living into one’s lifestyle.	
05.02	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.	
05.03	Identify the risk factors for cardiovascular disease.	
05.04	Describe the effects of tobacco and smoking on the human body.	
05.05	Describe the various fitness methods to improve health.	
05.06	Discuss the effects of nutrition on health and wellness.	
05.07	Explain body composition and achieving a healthy weight.	
05.08	Describe stress management strategies.	
05.09	Discuss the use and abuse of illicit drugs in society.	
05.10	Describe the effects of chronic disease on the human body.	
06.0	Demonstrate knowledge of health communication and its impact on health outcomes. – The student will be able to:	
06.01	Describe key concepts and skills used to identify individuals with reduced health literacy.	
06.02	Explain how understanding health literacy is as a determinant of health.	
06.03	Discuss how to best provide culturally-appropriate communication and care starting with an awareness of one’s own culture and the skills needed to provide sensitive and meaningful care and services to others.	
06.04	Discuss basic constructs of theories used in behavior change and persuasion.	
06.05	Classify health communication programs based on disease type (e.g. chronic vs. infectious).	
06.06	Determine communication methods to be used in specific settings (healthcare, school, and workplace).	
07.0	Demonstrate knowledge of the three primary levels of prevention. – The student will be able to:	
07.01	Discuss implementation methods of prevention used in public health: education, motivation and obligation.	
07.02	Describe the three levels of prevention in public health: primary, secondary and tertiary.	
07.03	Explain how preventative methods can be used throughout the life-cycle.	
07.04	Identify individual and community prevention needs in order to connect available resources to distressed areas.	
07.05	Summarize specific primary prevention methods including: vaccinations, exercise, nutrition counseling, and birth control.	
08.0	Demonstrate the use of evidence to draw conclusions about disease etiology. - The student will be able to:	
08.01	Define evidenced based thinking in public health.	
08.02	Identify evidence based recommendations to determine disease etiology, benefits and basic recommendations for prevention.	
08.03	Discuss health information concepts related to economic, legal and social issues.	
08.04	Investigate a problem by using evidenced based thinking skills to define a health problem and determine what information is    needed to make a decision.	
08.05	Locate and evaluate online health information to determine appropriate audiences are reached using specific content to the demographic group.  	
09.0	Demonstrate knowledge of current events in the field of public health. – The student will be able to:	
09.01	Identify outlets (news, media, governmental) used to communicate public health events to the general public.	
09.02	Describe the implications of current events on public health.	
09.03	Discuss concerns related to how public health information is relayed to the public.	
09.04	Recognize how reporting of global events (e.g. epidemics, regime change, and weather events) has the potential to impact other areas.	
09.05	Locate emerging public health trends.	
09.06	Explain etiology of emerging public health trends discussed throughout semester.	
09.07	Discuss legislation designed to protect the public’s right to information during major health events (epidemics, terrorism, natural disasters).	
10.0	Demonstrate the ability to identify U.S. health care delivery funding sources. – The student will be able to:	
10.01	Demonstrate an understanding of the evolutionary perspective of health services and its relevance with the existing healthcare system, facilities and services.	
10.02	Explain the social, political, and public policy implications of health-related issues, such as availability, cost, delivery, and financing.	
10.03	Describe the various health care organizations and service delivery options.	
10.04	Identify the major health professions and explain the role of each and their licensing/educational requirements.	
10.05	Compare and contrast the health care delivery systems of the U.S. with other major industrialized nations.	
10.06	Understand the array of career choices in the health care sector of the economy.	
10.07	Discuss the various sources and uses of funds for healthcare as well as market trends and future implications.	
11.0	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:	
11.01	Describe key concepts and skills used in the site-sponsor relationship.	
11.02	Classify clinical research funding sources and the protocols used to secure funding.	
11.03	Discuss basic constructs related to grants & contracts management in clinical research.	
11.04	Provide examples of the types of lifecycles of clinical trials.	
11.05	Define the terms and language used in startup & closing Items on clinical research.	
11.06	Determine communication methods to be used in the startup and closing of items in clinical research.	
12.0	   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:	
12.01	Accurately describe the processes involved in clinical research.	
12.02	Define and describe issues associated with participant consent.	
12.03	Explain the goals, limitations and basic rules for screening participants.	
12.04	Discuss market and social aspects of product development (drugs & devices).	
12.05	Discuss impacts of clinical trial stakeholders.	
12.06	Accurately describe how epidemiology is used in clinical research.	
12.07	Explain the relationship between essential processes related to adverse events & safety.	
13.0	Demonstrate knowledge of the guidelines and regulations governing clinical trials.– The student will be able to:	
13.01	Understand the array of guidelines & regulations governing clinical trials.	
13.02	Describe the various HIPPAA Privacy & clinical research privacy issues.	
13.03	Identify the major GCP/ICH guidelines related to working with human subjects in research	
13.04	Discuss the various sources and uses of essential documents generated from clinical studies.	
13.05	Explain the role of compliance in maintaining fidelity to a study protocol.	
13.06	Provide examples of a standard response to a request for documentation of meeting award conditions.	
13.07	Understand the array of analysis techniques used in interpreting research findings.	
14.0	   Demonstrate ability to work as a clinical research professional.– The student will be able to:	
14.01	Identify clinical and behavioral research settings where Clinical Research Professionals are employed.	
14.02	Demonstrate an understanding of the essential duties of a Clinical Research Professional.	
14.03	Describe procedures and processes used to protect research participants at placement site.  	
14.04	Discuss the core research activities of placement site.	
14.05	Demonstrate an understanding of how placement site works with: local, county, state and federal agencies to carry out their research activities.  	
14.06	Evaluate the role of Clinical Research Professionals in research settings.	
14.07	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.	
15.0	   Demonstrate knowledge of the compliance and monitoring issues in clinical research.– The student will be able to:	
15.01	Describe the role of compliance in clinical research.	
15.02	Identify issues related to compliance in human subject’s research.	
15.03	Explain activities associated with monitoring within the scope of clinical research.	
15.04	Discuss processes used to resolve issues that may arise from monitoring as part of a clinical trial.	
15.05	Provide examples of quality assurance audits used in clinical research and discuss their value in relation to performing research with human subjects.	
15.06	Define the types of inspections clinical research facilities are subject to.	
16.0	   Demonstrate knowledge of Institutional Review Board functions and operations including purpose, review types and composition. In addition, ethical issues within clinical research will be introduced.– The student will be able to:	
16.01	Define an IRB's: purpose & membership.
	
16.02	Explain the historical significance of IRBs.	
16.03	Explain the goals, limitations and basic rules for screening participants.	
16.04	Provide examples of international and federal laws that scaffold the duties IRBs.	
16.05	Discuss IRB: functions & operations.	
16.06	Describe IRB: document review & approval.	
16.07	Classify and demonstrate an understanding of IRB review processes: expedited Review vs. continuing Review	
16.08	Identify essential documents used by the IRB: approval & review letters, site and staff documents.	
17.0	Demonstrate knowledge of the principles and language of pharmacology, including drugs and drug classes, diagnostic tests, indications, techniques.-The student will be able to:	
17.01	Describe pharmacological principles.
	
17.02	Classify routes of administration.
	
17.03	Describe the relationships of drug classes with disease processes and medical specialties.
	
17.04	Recognize commonly prescribed medications	
17.05	Use appropriate pharmacological and laboratory references.
	
17.06	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.

Special Notes

General Education Course Requirements for AS and AAS Degrees

State Board of Education Rule 6A-14.030 (4) F.A.C. identifies 15 credit hours as the minimum amount of general education coursework required in the Associate of Science degree and the Associate of Applied Science degree. In addition, Rule 6A-14.0303 FAC implements section 1007.25 Florida Statutes and requires students entering a technical education degree program in the 2022-2023 academic year, and thereafter, to complete at least one identified core course in each subject area as part of the general education course requirements (15 credit hours total) before a degree is awarded) The core subject areas include: 
•	Communication. 
•	Humanities.
•	Mathematics. 
•	Natural Sciences.
•	Social Sciences.

Career and Technical Student Organization (CTSO)

HOSA is 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.

Certificate Programs

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 AS degree program includes the following College Credit Certificates:

Clinical Research Coordinator (0351071901) – 30 credit hours

Standards for the above certificate programs are contained in separate curriculum frameworks.

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