Contact Us:
E-mail the department
Phone: (510) 642-1062
Advisory Board
Jane M. Alexander, B.S.N., M.P.H.
Associate Director,
Clinical Operations
Ilypsa, Inc.
Lincoln Bynum, M.D.
Vice President for Medical
Consulting and Product
Development Services,
ICON
Clinical Research
Karen A. Henry, BBA, M.P.H.
Manager, Clinical Operations
NeuroMolecular Pharmaceuticals, Inc.
Michael Huston, B.S., M.B.A., RAC
Principal, Huston Associates, LLC
Meng Lin, O.D., Ph.D.
Director
Clinical Research Center
School of Optometry
University of California, Berkeley
Madeline Miller, D.V.M.
Senior Director,
Project and Portfolio Management
Gilead Sciences, Inc.
Kenneth A. Polse, OD, M.S., FAAO
Prof. of Graduate Studies
Director, Berkeley Clinical Scientist Development Program
School of Optometry
University of California, Berkeley
Beverly D. Smolich, Ph.D.
Biotechnology R&D Consultant
Helen Street, M.S., RN
CEO, Clinical Research,
H Street Consulting
Mariana Tran, M.B.A., Ph.D.
Vice President,
Business Development & Operations,
Cardinal Clinical Research, Inc.
Liz Wool, BSN, CCRA, CMT
President and CEO,
QD-Quality and Training Solutions, Inc.
Clinical Research Conduct and Management
(EDP 402248)
About the Program
The human testing process known as the clinical trial is a key step in the drug development process. Regulations and guidelines govern clinical trials, and a thorough knowledge of procedures at every stage of the process is essential. The Professional Sequence in Clinical Research Conduct and Management provides broad knowledge of clinical trials, through coverage of FDA regulations, ICH GCP guidelines, practical procedural guidelines, and ethical considerations. The program prepares students for occupations as monitors, clinical research associates (CRAs), project managers, and study coordinators at biotechnology and pharmaceutical companies, contract research organizations, and investigational sites. Those already in the field will enhance their prospects for advancement.Program Format
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The professional sequence can be completed in two semesters (one year). It consists of four modules and three stand-alone courses. The modules must be taken in sequence. The stand-alone courses may be taken out of sequence. The program is offered in hybrid format in collaboration with ClinfoSource, and combines the convenience of online course access and the advantages of in-class meetings. Class meetings include lectures, discussions, exercises, and case studies. Any student is free to take individual courses rather than follow the complete program.
Access to Online Material
Students in the certificate program who register at least 10 days before the start of the class will be given access to the online material a week before the start of classes. All other students in the class will be given access to the online material no later than 3 business days after the first meeting of the class.Who Should Attend
The program is for those considering a career in clinical research. It is recommended for those who are currently in allied areas in the biotechnology industry and wish to develop an understanding of clinical research and/or are considering a career change. The program is also intended for those who are new to the clinical research field.Find Out More
The program was developed in collaboration with ClinfoSource.Accreditation
All courses have been accredited by the California Board of Registered Nursing (BRN) to provide continuing education credit. Provider #00226.Course Order and Prerequisites
The modules must be taken in sequence and some of the courses have prerequisites. Please read the course prerequisites before registering.Required Courses
Module A: Introduction to Clinical Research X454 (2 units)Clinical Trials: Phases and Design X440.6 (1 unit)
Module B: Clinical Trial Planning and Preparation X440.1 (2 units)
Project Management and Outsourcing X498.1 (1 unit)
Module C: Clinical Trial Initiation and Implementation X440.5 (2 units)
Data Management and Biostatistics X498.2 (1 unit)
Module D: Regulatory Reports and Audits X440.8 (2 units) (offered spring 2010)
Certificate Requirements
The modules and classes must be completed with a letter grade of C or higher to count toward a certificate of completion. The maximum time for the completion of the certificate is two years.Registration Procedure
We recommend that you register for the professional sequence before you begin your second course in the program. To register, please (1) complete and submit the Program Registration Form or (2) print out and complete the form at www.unex.berkeley.edu/cert/certproginfo.html. Mail or fax it as it indicates, and include the nonrefundable registration fee. Professional sequence registration cannot be taken by phone.Requirements may be updated based on new developments in the field of study; we recommend completing the program in a timely fashion.
Students in the certificate program who register at least 10 days before the start of the class will be given access to the online material a week before the start of classes. All other students in the class will be given access to the online material no later than 3 business days after the first meeting of the class.
The Professional Sequence in Clinical Research Conduct and Management is a hybrid program that consists of 50% classroom instruction and 50% online instruction. Listed below are the required courses for the certificate and the recommended order to complete them (determined by which term you begin with).
If you start the program in the fall semester:
| Fall Semester | Spring Semester |
| 1. Module A: Introduction to Clinical Research | 4. Project Management and Outsourcing |
| 2. Clinical Trials: Phases and Design | 5. Module C: Clinical Trial Initiation and Implementation |
| 3. Module B: Clinical Trial Planning and Preparation | 6. Data Management and Biostatistics |
| 7. Module D: Regulatory Reports and Audits |
If you start the program in the spring semester:
| Spring Semester | Fall Semester |
| 1. Module A: Introduction to Clinical Research | 4. Project Management and Outsourcing |
| 2. Clinical Trials: Phases and Design | 5. Module C: Clinical Trial Initiation and Implementation |
| 3. Module B: Clinical Trial Planning and Preparation | 6. Data Management and Biostatistics |
| 7. Module D: Regulatory Reports and Audits (This course is taken the following spring semester) |
What We Offer
- Streamlined one-year curriculum
- UC Berkeley-approved courses
- Evening and weekend class schedule. (Classes meet approximately every other Saturday, for two semesters.)
- Online access to course materials
- Hybrid format utilizing classroom instruction and the Web
Classroom Topics
| Meeting # | Topic |
| Module A: Introduction to Clinical Research* | |
| 1 | Introduction to clinical research;
Ethical considerations in clinical research |
| 2 | Principles of Good Clinical Practice (GCP);
IRBs/IECs; Investigator responsibilities |
| 3 | Sponsor/vendor responsibilities;
IND filing Module Exam |
| *Medical terminology module will be available online throughout Module A, but not discussed in class | |
| Clinical Trials: Phases and Design | |
| 4 | Drug Discovery and Development; Phases of Clinical Trials |
| 5 | Clinical Trials Design Exam |
| Module B: Clinical Trial Planning and Preparation | |
| 6 | Protocol development;
CRF design |
| 7 | Informed
consent— elements
and
documentation;
Informed consent— process and exceptions |
| 8 | Site selection;
Pre-study visits; Site contracts and budgets Module Exam |
| Project Management and Outsourcing | |
| 9 | Project planning; Vendor selection |
| 10 | Project management; Vendor management Exam |
| Module C: Clinical Trial Initiation and Implementation | |
| 11 | Regulatory documents overview and central files setup;
Site initiation/ investigator meetings |
| 12 | Subject recruitment and retention strategies;
Global clinical trials |
| 13 | Routine monitoring;
CRF review/source document verification; Study drug accountability |
| 14 | Safety reporting;
Site/study close-out Module Exam |
| Data Management and Biostatistics | |
| 15 | Data management |
| 16a | Biostatistics and results
interpretation |
| 16b | Biostatistics and results
Exam/Interpretation Project |
| Module D: Regulatory Reports and Audits | |
| 17 | Clinical study report (CSR) writing;
NDA filing |
| 18 | Sponsor/CRO: regulatory compliance and audits;
Investigational site audits |
| 19 | Electronic records and signatures; Clinical trial SOP development;
General Q&A on all topics; careers in clinical research discussion Module Exam |
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