University of California, Berkeley - Extension
Certificate Program in Clinical Research Conduct and Management
Berkeley, USA
Certificate
DURATION
LANGUAGES
English
PACE
Full time
APPLICATION DEADLINE
EARLIEST START DATE
TUITION FEES
USD 8,210
STUDY FORMAT
Distance Learning
The certificate develops expertise in the essential elements of conducting and managing clinical trials for medical treatments and devices. Topics include clinical trial design and phases; good clinical practices; the drug discovery and development process; quality control and assurance; legal and ethical aspects of clinical research; FDA regulations; International Council for Harmonisation (ICH) guidelines; compliance; and bioethics. An advisory board of academic and industry professionals oversees the curriculum. The program comprises four required courses totaling 12 semester units and 180 instructional hours. Courses must be completed sequentially, taken for a letter grade, and passed with a grade of C or better. The certificate can be completed in two semesters (one year), and all coursework must be completed within five years.
The curriculum consists of four required courses totaling 12 semester units and 180 instructional hours. The courses must be completed sequentially. Students may move between the hybrid format and the fully online format as long as all four required courses are completed in sequence. Additional courses of related interest are available but are not required. The certificate can be completed in two semesters (one year), while all coursework must be completed within five years.
The page links to general Financial Aid information but does not identify a scholarship or funding opportunity specific to this program.
The certificate is presented as preparation for progression through clinical research roles including Clinical Research Assistant, Clinical Research Coordinator, Clinical Research Associate (CRA), Study Manager/Clinical Project Manager, and Director of Clinical Operations. Responsibilities described include clinical research support, site-level trial coordination, clinical monitoring, study planning and execution, and operational leadership. Students may apply the program's instructional hours toward eligibility requirements for the Certified Clinical Research Professional Certification by the Society of Clinical Research Associates (SOCRA), and may apply course credit toward maintenance of certification through the Association of Clinical Research Professionals (ACRP).