Instructor Pool - Clinical Research, Regulatory Affairs, and Biotechnology - UC Berkeley Extension

y; increase access to higher education for non-traditional, online, and international students; and improve the workforce. UC Berkeley Extension is a part of the division under the leadership of the Dean of Extended Education that also includes Berkeley Summer Sessions, Berkeley Study Abroad, and Osher Lifelong Learning Institute.

UC Berkeley Extension invites applications for a pool of qualified, dynamic instructors with a commitment to undergraduate, professional, and continuing education in Clinical Research, Regulatory Affairs, and Biotechnology to teach one or more online courses each year for our Sciences, Mathematics, and Biotechnology department.

Courses are offered online:
• Online instruction is delivered asynchronously through our learning management system (Canvas) or through synchronous live lectures (Zoom).
• Most synchronous live online lecture courses are offered in the evening and on the weekend (U.S.A. Pacific Time).

Course Subjects

We are seeking qualified applicants who possess current subject matter expertise and/or teaching knowledge in (but not limited to) the following course subjects. For program and course descriptions, please refer to the departmental link below.

Clinical Research
• Introduction to Clinical Research: Clinical Trial Phases and Design
• Clinical Trial Planning: Protocol Development, Data Management and Clinical Site Activities
• Clinical Trial Implementation: Site Initiation, Subject Recruitment, Monitoring and Safety Reporting
• Clinical Trial: Data Analysis, Regulatory Audits, Vendor Selection and Project Management

Regulatory Affairs
• Principles of Regulatory Affairs: Pharmaceuticals and Medical Devices
• Submissions and Commercialization
• Preparation, Submission and Agency Interfacing
• Harmonization Across Worldwide Applications
• Post-Approval Activities
• Principles of Supply Chain and Manufacturing
• Principles of Product and Process Development
• Principles of Quality and Compliance
• Regulatory Compliance for Pharmaceutical Products

Other Biotechnology Courses
• Drug Development Process
• Other Biotechnology course topics (please specify in your cover letter)

Teaching Experience
• Classroom Teaching Experience
• Synchronous Online Teaching Experience (online lectures via Zoom)
• Asynchronous Online Teaching Experience (via learning management system)

General Duties

The department seeks candidates who can support the success of all students through inclusive curriculum, classroom environment, and pedagogy. Specific duties and expectations will vary depending on the method of instruction including: Synchronous Live Online (Zoom) or Asynchronous Online (Fixed Date).
• For synchronous instruction (live online courses), duties include but are not limited to: syllabus development; assignment development; lesson planning for class meetings; preparing and submitting required texts and course materials; reviewing and updating Canvas course site; and delivering lectures, presentations, and learning activities for all required hours of instruction.
• For asynchronous instruction (fixed date online courses), duties include but are not limited to: reviewing the syllabus and pre-populated online course content; learning and utilizing Canvas classroom management tools; and requesting any training needs from the Program Director or Department Director.
• For all instruction (regardless of course format) duties include but are not limited to: completing required trainings as mandated by the UC Presidential policies; responding to student questions and learning needs in a timely manner; grading student assignments and posting final student grades to the instructor portal in a timely manner; utilizing University-approved course support platforms including the Canvas Learning Management System, Zoom, Instructor Portal, Google Workspace, etc.; reviewing and following University and departmental policies, logistics, and other guidelines as published on the departmental Instructional Resource Site; and responding to other requests from the Program Director or Department Director in a timely manner.