Clinical Trials Site Monitoring II

This course explores a range of approaches to monitoring clinical sites, the development of monitoring plans, and some of the more challenging aspects of monitoring clinical trials. Remote data entry, compliance audits, regulatory issues that arise in compliance audits, fraud and misconduct are also addressed. This course is designed for clinical research associates (CRAs) or those planning to become a CRA, clinical trial managers and clinical operations managers.

Professional Credit: CA BRN/LVN Credit--Provider #CEP13114.



Offering code Offering title
CTDM.X404 Clinical Trials Site Monitoring I

Sections :

Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X405.(1) 5/11/2018 05:00 PM SANTA CLARA 580 View Enroll

Contracting with Contract Research Organizations (CROs)

Pharmaceutical and biotechnology companies are more and more frequently using the services of contract research organizations (CROs) to access expertise or technology not available in-house for key clinical services in an effort to most effectively use limited resources. This course covers the identification, selection, and management of CROs in the performance of clinical projects.


No prerequisites

Sections :

Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X406.(1) 8/24/2018 09:00 AM SANTA CLARA 580 Denise Sharp View Enroll

Document Preparation: Protocols, Reports, Summaries

Clinical trial documentation must be clear, scientifically sound, conform to regulations and established standard operating procedures, and follow regulatory guidelines. Despite pressure to start the trial "yesterday," a clinical trial cannot begin without a study protocol in place. Many other documents are needed before and during the trial, and the trial does not end until a final report has been submitted. Documentation of the trial often continues with articles in the biomedical literature.


Offering code Offering title
CTDM.X411 Good Clinical Practices

Sections :

Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X408.(1) 4/7/2018 08:30 AM SANTA CLARA 580 Romi Behbehanian View Enroll

Electronic Data Capture for Clinical Trials

A major trend among life science organizations has been the recent shift from manual, paper-based clinical data collection processes to the predominant use of electronic systems that expedite the availability of accurate clinical trial data. This course examines some of the key issues surrounding the industry's adoption of Electronic Data Capture (EDC) and gives students the opportunity to use EDC software on classroom computers during simulated clinical trials.


No prerequisites

Sections :

Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X410.(2) 6/22/2018 06:00 PM SANTA CLARA 580 Jeffrey H. E. Sonas View Enroll

Clinical Trials, Regulatory Affairs, and Medical Device Information Session

Are you interested in learning about the Clinical Trials, Regulatory Affairs, and Medical Device certificate programs, and about careers in these fields?
This special information session provides an opportunity to meet instructors and other students, learn about program prerequisites, program philosophy, course content and program requirements, and gain insights into careers in clinical research, regulatory affairs, and medical devices.


No prerequisites

Clinical Trials Design and Management Certificate Completion Review

Once all of the certificate requirements have been met and your final grades are posted, please access your Student Portal to enroll in the “Certificate Completion Review” to begin the review process. Please allow up to 4 weeks to receive your certificate.


No prerequisites

Sections :

Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
O-CE0113.(008) // 04:00 PM 75 View Enroll

Bioscience Program Information and Q&A Session

This free evening event is an informal discussion geared towards new or returning students interested in one or more of the Bioscience certificate programs -- Biotechnology, Bioinformatics, Clinical Trials, Medical Devices, and Regulatory Affairs. The event begins with a short overview of the Bioscience certificates, followed by an open-floor segment for audience questions.


No prerequisites

Clinical Trials Design and Management


Pharmaceutical, biotechnology and medical device companies are growing at a fast clip, due to strong spending on research and development, the rise of biopharmaceuticals and the increased health care needs of an aging population. These factors have led to a booming demand for access to talent for the clinical trials needed to ensure product safety and effectiveness.
—"What's the Outlook for Hiring in Clinical Trials?" Aerotek, a global recruiting company (Nov. 1, 2017)

Lead the Way in Clinical Trials

Q: When new drugs are introduced, how do companies test for quality and safety?

A: Well-planned and well-executed clinical trials are the cornerstone of effective biomedical product development and are critical to ensuring the protection of human volunteers. Our Clinical Trials Design and Management certificate will help clinical professionals navigate the entire clinical trials process, from drug and device development to monitoring and post-marketing activities. You’ll also learn the scientific principles, regulations and ethics that are critical to the conduct of clinical research.

Pick up skills course by course or declare candidacy for the certificate to add a UC credential to your resume.

Earn Professional Credit

Many of our courses qualify for recertification Continuing Education Units for certified Clinical Research Associates and Clinical Research Associates affiliated with the Association of Clinical Research Professionals. Nurses can also earn BRN credit for some courses.

Intensive Approach

New to the field? Check out our weeklong “Clinical Trials Essentials” course to get a comprehensive overview of the industry in just a few days.

Earn Two Certificates For Less

Complete two Bioscience certificates, simultaneously or in sequence, with fewer units, by selecting shared electives. Contact us to get help creating a personalized study plan.


“Thanks to UCSC Silicon Valley Extension, I had the foundation to start my career once again.” –Archita Sharma

The Profession
"Job prospects will be best for medical and clinical laboratory technologists and technicians who complete an accredited education program and earn professional certification."

— Bureau of Labor Statistics, U.S. Department of Labor, Occupational Outlook Handbook, Medical and Clinical Laboratory Technologists and Technicians

A Competitive and Evolving Industry
To launch and maintain an effective clinical trial, companies must rely on a diverse and qualified team of research associates, site coordinators and monitors, and sales and marketing personnel. Medical professionals with a background in clinical trials can apply their skills to various careers, including:

•  As clinical research coordinators (CRC) or clinical research associates (CRA)
•  As clinical program managers and physicians
•  Institutional Review Board members and administrators
•  Pharmacists
•  Biomedical and research scientists
•  Data managers


Average Earnings
According to data from job postings on Glassdoor in October 2016, the national average for clinical research associate salaries was $57,540—and the average in Silicon Valley hit $74,623. –Glassdoor

Market Relevance
In 2016 the market size for biotech is reported at $311 billion; for pharma, $1.11 trillion; and for medical tech, $369 billion.  –Deloitte, 2016 Global Life Sciences Outlook

Job Prospects
Employment of medical scientists was projected to grow 8 percent annually from 2014 to 2024. This demand reflects a need for scientists who can contribute to the development of treatments and medicines that improve health. Employment of medical laboratory technologists is projected to grow 12 percent from 2016 to 2026, faster the average for all occupations. Employment of medical laboratory technicians is projected to grow 14 percent from 2016 to 2026, faster than the average for all occupations.

The Biotech Bay™ Hotbed community highlights the organizations that comprise the biotechnology, pharmaceutical and medical device industries in San Francisco and Northern California along with job listing and career resources.


“When I started my career in the USA, the classes completed the whole puzzle for me, combining my medical knowledge and PhD experience with operational and regulatory side of conducting clinical trials in pharmaceutical industry.” –Alexandra Steinberg


Program Objectives

•  As a graduate of the Clinical Trials Design and Management certificate program, you’ll have the skills to:
•  Understand and apply Good Clinical Practices (GCP)
•  Distinguish regulatory requirements and differentiate between regulations, guidelines, policies and standard operating procedures (SOP)
•  Identify the roles, responsibilities, interactions and concerns of study site personnel
•  Use coding dictionaries such as MedDRA® and WHO-Drug for adverse event reporting
•  Prepare clinical trial reports, summaries and other documentation
•  Understand clinical trials designs, management, and approval objectives for drug and device development.
•  For successful interactions with clinical sites, investigators, regulators, contract research organizations, and sponsor management. 
•  Understand the use of statistics in designing clinical trials and analysis of results.


At UCSC Extension, courses are developed by program chairs and faculty according to the rigorous University of California standards and designed to meet the economic needs of each industry. Our instructors represent the best of both worlds.

Program Chair

MICHAEL HUSTON, M.B.A., B.S., principal of Huston Associates, LLC, has more than 30 years of experience in development, from basic research to strategic drug development. He has directed project teams through lead identification, IND-enabling and nonclinical pharmacology studies, Phase 1-3 clinical studies, and several new drug applications (NDA), abbreviated new drug applications (ANDA) and biologic license applications (BLA), and product launches.  He currently consults for interdisciplinary programs in drug development. Mr. Huston has taught for UCSC Extension since 1999.


Program Format

UCSC Extension’s Clinical Trials Design and Management courses are offered at UC Santa Cruz Silicon Valley Campus, a beautiful facility located on the corner of Scott and Bowers in Santa Clara. Many of our courses are available online. Choose courses according to your interest or declare candidacy in the certificate for a more comprehensive overview of the field.

Clinical Trials Courses

Total: 19 units

Required: 6 courses

Electives: 5 units required

To complete the certificate, you must complete a minimum of 19 units; 6 required courses and at least 5 units of elective courses.


  • Medical/Clinical Terminology, 0.7 CEUs
  • Human Physiology in Health and Disease, 3 units

Required Courses:

  • Drug Development Process, 3 units
  • Medical Devices: Regulatory Strategies and Marketing Pathways, 1.5 units; or  Regulation of Medical Devices and Diagnostics, 3 units
  • Good Clinical Practices, 3 units
  • Clinical Trials Site Monitoring I, 2 units
  • Science of Clinical Trials Design, 2.5 units
  • Clinical Statistics for Non-Statisticians, 2 units


5 units required

  • Clinical Data Management, 2 units
  • Clinical Project Management, 2 units
  • Clinical Research: The Study Site Perspective, 1.5 units
  • Contracting with Contract Research Organizations (CROs), 1.5 units
  • Data Privacy and Security for Healthcare and Biosciences, 1.5 units
  • Document Preparation: Protocols, Reports, Summaries, 1.5 units
  • Drug Safety and Adverse Events Reporting, 1.5 units
  • Electronic Data Capture for Clinical Trials, 1 unit
  • Good Manufacturing Practices, 3 units
  • Medical Writing, 2 units
  • Preparing for FDA Inspections and Conducting Sponsor Audits, 1.5 units

Also of Interest

  • Biology of Cancer, 2 units
  • Clinical Trials Essentials: An Intensive One-Week Course, 3.5 CEUs
  • Viruses, Vaccines and Gene Therapy, 1.5 units


Familiarity with medical terminology is required. You can satisfy this requirement by taking "Medical/Clinical Terminology," an equivalent course, or substituting relevant work experience. We strongly recommend that students without a medical background take "Human Physiology in Health and Disease" early in their studies.

Recommended Course Sequence

After completing the prerequisites, we recommend that you begin the program with "Drug Development Process." From that point on, courses may be taken in any sequence unless otherwise specified.


Want to learn more about our curriculum in person? Join us for a free Info Session to learn more about our courses, faculty, and program requirements. Learn more on our Events page.


The rough cost of the Clinical Trials Design and Management certificate is estimated at $8000.



No application is required to enroll in our courses or certificate programs. Information about our open enrollment process can be found on our Enrollment page. If you have any questions about our programs, please contact the UCSC Extension Outreach office by phone at 408-861-3860, or by email at

From the schedule below, click on a course title to see sections available for enrollment. You may view the full course schedule, or enroll in the course, by clicking the respective button. The course type offerings (classroom, online, blended) are guidelines and subject to change. A blended (hybrid) course has both classroom and online components.

Declaring Candidacy

If you intend to pursue a certificate, declaring candidacy establishes program requirements early in your studies, so any subsequent curriculum changes do not affect your progress. It does not limit what courses you can take; and it helps you structure your professional development program for maximum benefit to you. Go the declare candidacy page to establish your requirements for this program. Certificate program requirements must be completed within three years of declaring candidacy.

Course Schedule

1. Prerequisite Course
classroom : Classroom
online : Online
hybrid : Blended
Offering Code Offering Units Fall Winter Spring Summer
CTDM.X800 Medical / Clinical Terminology 0.7 CEU Classroom Classroom
2. Recommended Prerequisite Course
classroom : Classroom
online : Online
hybrid : Blended
Offering Code Offering Units Fall Winter Spring Summer
BTEC.X408 Human Physiology in Health and Disease 3.0 Classroom Classroom
3. Required Courses. Choose one Device Course.
classroom : Classroom
online : Online
hybrid : Blended
4. Elective Courses
5. Also of Interest
classroom : Classroom
online : Online
hybrid : Blended
Offering Code Offering Units Fall Winter Spring Summer
BTEC.X402 Biology of Cancer 2.0 Classroom
BTEC.X413 Viruses, Vaccines and Gene Therapy 1.5 Classroom
CTDM.X801 Clinical Trials Essentials: An Intensive One-Week Course 3.5 Classroom
6. Required Certificate Review
classroom : Classroom
online : Online
hybrid : Blended
Offering Code Offering Units Fall Winter Spring Summer
O-CE0113 Clinical Trials Design and Management Certificate Completion Review