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

Academic - Non-Tenure Track

UC Berkeley Extension, the professional and continuing education division at the University of California, Berkeley, invites applications for a pool of qualified instructors to teach in-person and online Clinical Research, Regulatory Affairs, and Biotechnology courses for the Sciences, Mathematics and Biotechnology department.

UC Berkeley Extension seeks dynamic instructors with a commitment to undergraduate, professional and continuing education in Clinical Research, Regulatory Affairs, and Biotechnology to lead one or more courses each year. The pool will remain in place for one calendar year; those interested in remaining in the pool beyond the advertised final closing date must reapply. The number of these positions varies from semester to semester, depending on the needs of the department.

Courses are offered in-person and online.

• Classroom instruction takes place at our centers in Berkeley and San Francisco, California (U.S.A.).
• Online instruction is delivered through live lectures (Zoom) or asynchronously through our learning management system (Canvas).

Most classroom and live online lecture courses are offered in the evening and on the weekend (U.S.A. Pacific Time).

We are seeking qualified applicants who possess current subject matter expertise and/or teaching knowledge in the following course subject areas (but not limited to). For a complete list of programs and course descriptions, please refer to the departmental links below.

• 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

• 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

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

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

Instructor duties include but are not limited to:

• Complete mandatory training programs by deadlines established by UC Berkeley.
• Complete required administrative tasks in a timely manner including: updating and submitting syllabi using approved syllabus template; communicating required texts and materials; communicating classroom technology and support needs.
• Make appropriate adjustments to continually improve the syllabus, curriculum and course materials. May be based upon programmatic and/or student feedback.
• Prepare and deliver course materials, lectures/presentations, and design learning assessments.
• Design interactive and motivational classroom activities to fully engage participants and to reinforce student learning.
• Stay current within the subject, discipline or field of practice.
• Use subject-matter expertise and leverage additional resources appropriately to enhance the curriculum.
• Utilize course support platforms, including the Canvas Learning Management System and Zoom Pro (as applicable).
• Communicate teaching objectives and specific learning outcomes to students, and clearly outline/explain the grading policies for the course.
• Respond to student questions and learning needs in a timely manner.
• Employ culturally competent and inclusive teaching methodologies in the classroom (including teaching non-native speakers and/or students with academic letters of accommodations for disabilities).
• Evaluate student achievement of specific learning outcomes and assign grades.
• Post final student grades to the transcript system within two weeks of course completion.
• Handle student inquiries about final grades and consult with Program Director/Manager as needed.
• Retain student records according to University policies.

Clinical Research Conduct and Management Program: https://extension.berkeley.edu/public/category/courseCategoryCertificateProfile.do?method=load&certificateId=17168&selectedProgramAreaId=15498&selectedProgramStreamId=15604

Regulatory Affairs Program: https://extension.berkeley.edu/public/category/courseCategoryCertificateProfile.do?method=load&certificateId=17180

Clinical Research, Regulatory Affairs and Biotechnology Courses: https://extension.berkeley.edu/academic-areas/sciences-mathematics-and-biotechnology/?nav=5#!?tab=courses&programStream=Life%20Science%20Business%20and%20Biotechnology

• Advanced degree

• All work must be performed in the United States, whether in person or online. For those who are not US citizens or permanent residents, a legal permit that allows work in the United States (such as a US visa that allows employment) is required by the start date of the position. Due to the part-time, temporary nature of instructor positions, UC Berkeley Extension is unable to provide visa/work permits.

• Doctorate degree or equivalent international degree in course subject.
• 3 or more years of teaching, training or coaching experience in the course subject at a U.S. college/university institution or within a Clinical Research, Regulatory Affairs or other Biotechnology corporate environment.
• Knowledge of federal and California state laws and regulations as applicable to the course subject.
• License, certification or credential within a Clinical Research, Regulatory Affairs or other Biotechnology field.
• Experience in creating syllabi, learning objectives, lectures/presentations, learning activities, assignments, assessments, exams, and quizzes.
• Experience teaching and/or developing academic content for online courses.
• Ability to convey conceptual and complex ideas and information.
• Effective verbal/written communication and presentation skills (English).
• Effective organizational skills with attention to detail.
• Ability to collaborate with colleagues and work within a team environment.
• Proficiency in (or willingness to learn) instructional and other technology, such as: Learning Management Systems (Canvas); lecture/presentation capture applications (Panopto); online video conferencing (Zoom); Microsoft Office (Word and PowerPoint); file sharing (Google drive or Dropbox); and Google Workspace tools (email, calendar, docs, sheets, slides, etc).

• References are requested from candidates at the interviewing stage, and references are only contacted for finalists.

UC Berkeley is committed to diversity, equity, inclusion, and belonging. The excellence of the institution requires an environment in which the diverse community of faculty, students, and staff are welcome and included. Successful candidates will demonstrate knowledge and skill related to ensuring equity and inclusion in the activities of their academic position (e.g., teaching, research, and service, as applicable).

The University of California, Berkeley is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or protected veteran status.

Please refer to the University of California's Affirmative Action Policy and the University of California's Anti-Discrimination Policy.

In searches when letters of reference are required all letters will be treated as confidential per University of California policy and California state law. Please refer potential referees, including when letters are provided via a third party (i.e., dossier service or career center), to the UC Berkeley statement of confidentiality prior to submitting their letter.

As a University employee, you will be required to comply with all applicable University policies and/or collective bargaining agreements, as may be amended from time to time. Federal, state, or local government directives may impose additional requirements.