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Clinical Trials Design and Management

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About the Clinical Trials Design and Management Program

Conducting clinical research is essential to ensure the safety and efficacy of new drugs, biologics and medical devices. Following pre-clinical development, clinical trials require careful planning and cooperation among a variety of professionals within the pharmaceutical/biotechnology industry, clinical practice, and government agencies. From phase 1 (first in humans) to phase 4 (post-marketing) and every phase in between, clinical trials professionals need both specialized expertise and universal familiarity with a variety of procedures.

By learning key concepts, guidelines, regulations, and best practices, participants in the Clinical Trials Design & Management certificate program gain the skills needed to become part of an active clinical research workforce.

  • Develop substantive knowledge about coordinating and managing a clinical trial, including the drug development process, human subjects protection, working with institutional review boards (IRBs), and application of good clinical practice regulations and guidances from both FDA and ICH perspectives.
  • Learn how to set up a new clinical study; how to monitor clinical trials; as well as when, why, and how to engage clinical research organizations (CROs).
  • Build or reinforce essential skills, such as data management, site and investigator recruitment, and project management.
  • Discover a new understanding of oncology clinical research, from the basic science of cancer, to monitoring oncology trials.
  • Gain an overview of the entire clinical research process to identify the various career paths within the industry.
  • Be a part of a top-rated training program developed by leaders in the biotechnology/biomedical research industry.

The demand for highly trained professionals to coordinate and manage clinical trials for the local, national and global biomedical and biotech communities continues to grow rapidly.

  • Managers in training and others who want to refine or update skills
  • Research associates and coordinators
  • Biomedical and research scientists
  • Nurses and allied health professionals
  • Statisticians and database administrators
  • International clinical trials professionals
  • Individuals with degrees in science, psychology or related areas who are entering the field
Format: Online

In-class options might be available for some courses.

Estimated Cost: $4,500 - $5,200

Varies by course selection.

Duration: 6 - 24 months

Varies by student and courses taken per quarter.

Contact
Department
Healthcare & Behavioral Sciences
Phone
858-534-9261
Email
unexhealthcare@ucsd.edu

Courses

Delivery Method
Show Legend
  • Live Online
  • In-Person
  • Online
  • Hybrid
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Prerequisites

Medical Terminology: An Anatomy and Physiology ApproachFPM-40632

Units: 1.50

$295

Using an anatomy and physiology systems approach, this course reviews common terms associated with medical practice, research, and different healthcare settings. The goal: to better prepare individual...

Typically Offered:

Fall, Winter, Spring, Summer

Required Courses

CT: Drug Development ProcessFPM-40173

Units: 3.00

$545-$595

This keystone course examines the drug development process and history of clinical trials. Topics include sources of new drugs devices; the process of discovery; how a discovery becomes a drug or de...

Upcoming Start Dates:
Typically Offered:

Fall, Winter, Spring, Summer

CT: Human Subjects Protection and IRBsFPM-40388

Units: 2.00

$435-$475

This essential course offers an ethical framework for human subjects regulations, introduces regulatory issues in clinical trials, and reviews concern for human subjects protection in drug/device tria...

Upcoming Start Dates:
Typically Offered:

Fall, Winter, Spring, Summer

CT: Good Clinical PracticesFPM-40204

Units: 3.00

$545-$595

Topics include the definition and identification of good clinical practices (GCPs); how GCPs affect the conduct of clinical trials; regulating agencies and applicable regulations from the Code of Fede...

Upcoming Start Dates:
Typically Offered:

Fall, Winter, Spring, Summer

Electives

14 units are required

Clinical / Scientific Topics

CT: Science of Clinical Trials DesignFPM-40205

Units: 3.00

$595

This course reviews the nuts-and-bolts of effective clinical trial design and the basic anatomy of a clinical trial. Topics include trial designs by stage in drug/device development; the various types...

Upcoming Start Dates:
Typically Offered:

Winter, Summer

CT: Drug Safety: Surveillance and ReportingFPM-40206

Units: 2.00

$435

Common issues and concerns associated with drug safety surveillance within clinical trials are the focus of this course. Topics include the defining and identifying of adverse experiences, verifying d...

Upcoming Start Dates:
Typically Offered:

Spring

CT: Nuts and Bolts of Monitoring Clinical TrialsFPM-40187

Units: 2.00

$435-$475

See the Site from the Sponsor's perspective: important for both monitors and coordinators. Topics include responsibilities of sponsors and investigators; qualifying investigators; regulatory document...

Upcoming Start Dates:
Typically Offered:

Fall, Winter, Spring, Summer

CT: Advanced Monitoring and Management of Clinical Trials and Next StepsFPM-40240

Units: 2.00

TBD

This is a hands-on interactive live course, demystifies advanced site management and monitoring of clinical trials. Learn how to deal with difficult sites, problem solve and work with multiple priorit...

Upcoming Start Dates:
Typically Offered:

Fall, Winter, Spring, Summer

CT: Medical Writing: Protocols, Reports, Summaries, and SubmissionsFPM-40188

Units: 2.00

$435

No clinical trial can begin until a protocol has been written, and no clinical trial is complete until the final report is assembled, signed, and submitted to the FDA. Good documentation for clinical ...

Upcoming Start Dates:
Typically Offered:

Fall, Spring

CT: Practical Clinical Statistics for the Non-StatisticianFPM-40233

Units: 2.00

$435-$475

This course presents the statistics essentials for the non-statistician involved in clinical trials. Topics include study designs, hypothesis testing, sample size calculations, assumptions, controls, ...

Upcoming Start Dates:
Typically Offered:

Fall, Winter, Spring, Summer

CT: Understanding OncologyFPM-40493

Units: 3.00

$545-$595

Concepts of cancer treatment and management will be communicated to the student through a series of web-based sessions, with a sharp focus on the terminology, pathology, diagnostics, disease managemen...

Upcoming Start Dates:
Typically Offered:

Fall, Winter, Spring, Summer

CT: Monitoring Oncology TrialsFPM-40494

Units: 3.00

$545-$595

Monitoring oncology clinical trials requires advanced skills, including understanding and maintaining complete regulatory documents; protocol data integrity; patient safety; and the successful compl...

Upcoming Start Dates:
Typically Offered:

Fall, Winter, Spring, Summer

Regulatory Topics

CT: Regulation of Drugs, Biologics, Devices, and DiagnosticsFPM-40189

Units: 3.00

$545-$595

This course reviews the breadth of U.S. and international regulations associated with the development of drugs, biologics, medical devices, and diagnostics. Topics include a review of regulatory agenc...

Upcoming Start Dates:
Typically Offered:

Fall, Winter, Spring, Summer

CT: Prospective Preparation for Internal and External AuditsFPM-40207

Units: 1.00

$275-$295

This course provides a step-by-step outline of internal and external audits as well as ongoing actions that should be taken to prepare for an audit. Topics include types of audits; the audit process (...

Upcoming Start Dates:
Typically Offered:

Fall, Winter, Spring, Summer

Good Manufacturing PracticesBIOL-40000

Units: 3.00

$675

Gain a comprehensive understanding in FDA compliance with current good manufacturing practices (cGMPs), as regulated and guided by national and international agencies for the pharmaceutical and indust...

Upcoming Start Dates:
Typically Offered:

Fall, Winter, Spring, Summer

Good Laboratory PracticesBIOL-40085

Units: 2.00

$595

By addressing fundamental regulatory compliance principles relative to the FDA's current Good Laboratory Practice regulations, this course will show how GLP's affect the conduct of non-clinical labora...

Upcoming Start Dates:
Typically Offered:

Winter, Summer

Project Management topics for sponsors of clinical trials

CT: Project Management in Clinical TrialsFPM-40656

Units: 3.00

$545-$595

It has become increasingly more important to use solid project management principles when managing clinical trials. This course teaches the basic skills of project management derived from PMI principl...

Upcoming Start Dates:
Typically Offered:

Fall, Winter, Spring, Summer

CT: Clinical Study Implementation and ManagementFPM-40229

Units: 2.00

$435-$475

Examine the elements involved in implementing and monitoring a clinical study from the sponsor s point of view. Topics include finalizing the study materials; site selection; staffing and training; st...

Upcoming Start Dates:
Typically Offered:

Fall, Winter, Spring, Summer

CT: Data Management Systems for Sponsors of Clinical TrialsFPM-40218

Units: 2.00

$475

This course is designed to assist clinical trials sponsors to design data capture methods, and to organize and manage clinical trial data collected from one or more investigative sites. Topics in...

Upcoming Start Dates:
Typically Offered:

Summer

CT: Site and Investigator RecruitmentFPM-40208

Units: 1.00

$275-$295

This course is intended to help a clinical study sponsor recruit the appropriate sites and investigators for the study. Topics include sources of information on sites and investigators; approaching an...

Upcoming Start Dates:
Typically Offered:

Fall, Winter, Spring, Summer

CT: Working with Clinical Research Organizations (CROs)FPM-40228

Units: 1.00

$275-$295

This course provides the clinical study sponsor strategies for working with a clinical research organization (CRO) to conduct the study. Topics include assessing internal capabilities and limitations,...

Upcoming Start Dates:
Typically Offered:

Fall, Winter, Spring, Summer

Project management topics for clinical trials sites

CT: Patient Recruitment for Clinical TrialsFPM-40191

Units: 1.00

TBD

Learn to assist the clinical study site in recruiting appropriate patients for a clinical trials study, including oncology trials. Topics include targeting the appropriate study population; resources ...

Upcoming Start Dates:
Typically Offered:

Fall, Winter, Spring, Summer

CT: Setting Up a New Clinical StudyFPM-40179

Units: 2.00

$435-$475

As new clinical studies are designed and managed, each study should begin in a well-organized, well-planned manner. This online course assists the clinical study site in preparation for a new clinical...

Upcoming Start Dates:
Typically Offered:

Fall, Winter, Spring, Summer

Topics related to the environment surrounding clinical trials

CT: Financial Management of Clinical TrialsFPM-40338

Units: 1.00

$275-$295

Designed to illuminate the financial management of a trial from the sponsor perspective, this survey course includes prioritization of spending, costs involved in conducting a clinical trial (costs in...

Upcoming Start Dates:
Typically Offered:

Fall, Winter, Spring, Summer

CT: Becoming a Clinical Trials Principal InvestigatorFPM-40527

Units: 1.00

TBD

This course is designed for the physician who wants to enter the clinical trials arena. Topics include: the benefits and responsibilities of conducting clinical trials, choosing an appropriate trial f...

Upcoming Start Dates:
Typically Offered:

Fall, Winter, Spring, Summer

CT: Pharmaco-Economics and Effectiveness TrialsFPM-40209

Units: 2.00

TBD

This course examines the economic factors that must be considered when pursuing the development of a drug/device. Topics include the definition of health economics; points in the development process a...

Upcoming Start Dates:
Typically Offered:

Fall, Winter, Spring, Summer

CT: Preceptorship in Clinical TrialsFPM-40230

Units: 1.00

TBD

The student consults with the instructional advisor to identify and secure an appropriate preceptorship assignment, fulfilling at least 20 hours of work associated with that assignment, writing a pape...

Upcoming Start Dates:
Typically Offered:

Fall, Winter, Spring, Summer

Industry Certification

  • All courses offered are approved to fulfill eligibility requirements for the Certified Clinical Research Associate (CCRA) or Certified Clinical Research Coordinator (CCRC) credentials through the Association of Clinical Research Professionals (ACRP). Visit ACRP at www.acrpnet.org.
  • This certificate program has been evaluated and found to meet the current waiver requirement established by ACRP to waive 1,500 hours of hands-on experience performing the Essential Duties of the program to which the candidate has made application. (NOTE: Due to a recent change in ACRP policy, this waiver is active through December 2021. Students must have both completed the certificate program before or in 2021 and have also applied for the ACRP exam in 2021 for the waiver to apply).
  • Extension’s certificate applies to Category 3 of Candidate Eligibility for the Society of Clinical Research Associates (SOCRA) Certified Clinical Research Professional (CCRP) credential. Visit the Society of Clinical Research Associates (SOCRA) at www.socra.org.

Conditions for Admission

Please see the application for specific admission requirements for this program. Although a college degree or professional experience in the field are not required, applicants with such experience may receive preference for admission when program capacity is limited.

Certificate Guidelines

The three required courses have no substitutes, and cannot be waived. "The Drug Development Process" must be taken first, after any prerequisites and before any electives. The 14 elective units may be from any/all elective categories in the matrix. Contact unexhealthcare@ucsd.edu or 858-534-9261 for guidance.

Military spouses are eligible to use My CAA $4000 scholarship. Apply at MyCAA.
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Industry Requirements

Those pursuing the Clinical Research Coordinator (CCRC) or Clinical Research Associate (CCRA) credentials through ACRP, or the Clinical Research Professional (CCRP) credentials through SoCRA, can fulfill educational requirements by completing this program. For information about ACRP certification, please go to http://www.acrpnet.org. For more information about SoCRA certification, please go to http://socra.org.

Advisory Board

Jan Agee, CCRA

Clinical Trials Consultant

Fred Fowler

Manager, Business Development

Aerotek Scientific LLC

Timothy Mackey, MAS, PhD

Director & Associate Professor

UCSD Extension/UCSD - School of Medicine

Angela McMahill, JD, CHRC, CHC, CCRA

Executive Director, Research Compliance and Integrity

UCSD Office of Research Affairs

David Shapiro, MD

Chief Medical Officer and Executive VP, Development

Intercept Pharmaceuticals

Daniel Szpak, RN, CCRC

Clinical Research Nurse Manager

Clinical and Translational Research Institute (CTRI), UCSD

David Tanen, MD

Toxicology & Emergency Medicine

Emergency Medicine & Toxicology Legal Experts

Keith Vaux, MD

Clinical Professor of Pediatrics; Medical Director, CME

Rady Childrens Hospital SD

Terence Webb, PharmD, MBA

Consultant

MedVenture Consultants, Inc.

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This certificate requires an application before taking any courses. There will be a $0 fee to apply to this program. Students will also be required to pay a $95 certificate fee upon enrollment into the program after acceptance. View the complete Certificate Registration and Candidacy Guidelines.