Good Manufacturing Practices


Familiarity with the Good Manufacturing Practices (GMP) regulations is necessary for employees engaged in the manufacture, regulation, quality assurance, and control of drugs and biologics. Through lectures, discussions, and case studies, you’ll gain an understanding of the FDA GMP and Good Laboratory Practice (GLP) regulations.

Prerequisites :


No prerequisites


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.

Prerequisites :


No prerequisites


Clinical Trials Essentials: An Intensive One-Week Course


Well-planned and well-executed clinical trials are the cornerstones of effective drug and medical device development. Offered in an accelerated format and taught by leaders in the biopharmaceutical industry, this course provides a unique opportunity for professionals from all disciplines to learn about the many facets of clinical trials--the complex process that ensures the safety and effectiveness of medical products.

Prerequisites :


No prerequisites


Medical Writing


All biopharmaceutical companies must produce scientific reports and summary documents for regulatory agencies. Good documentation should be not only scientifically sound, but also clear, effective and concise. This course provides the practical skills needed to write effective documents for the healthcare industry. You'll gain practice through hands-on exercises and group projects based on documentation used in pharmaceutical development.

Prerequisites :


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X413.(3) 11/2/2018 06:00 PM SANTA CLARA 750 David A West View Enroll

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.

Prerequisites :


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
O-CE0113.(009) // 04:00 PM 75 View Enroll
Clinical Trials Design and Management

Group

About
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.

WHAT STUDENTS SAY

“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

WHAT YOU CAN EXPECT

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.

STUDENT SPOTLIGHT

“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

Outcomes

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.

FACULTY

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.

Curriculum

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.

Prerequisites:

  • 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

Electives:

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

Prerequisites

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.

INFO SESSIONS

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.

PRICE

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

Enroll

Enrollment

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 extensionprogram@ucsc.edu.

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 Online Online Online Online

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