Course Developer - Clinical Research, Regulatory Affairs, and Biotechnology - UC Berkeley Extension

Position overview

Salary range : A reasonable estimate for this position is $3,500 - $5,000 per online course development project. Course developer compensation is determined by the number of online course modules, budgetary considerations, and other factors.

Percent time : Part-time temporary appointments are offered by agreement on a project-by-project basis.

Anticipated start : Position is expected to begin in fall 2024.

Review timeline : Review of applications begins immediately and will continue as needed through November 2024.

Position duration : Appointment length is based upon project milestones, course design(s), and deliverables. Appointments may be renewable based on need, funding, and performance.

Application Window

Open date : August 7, 2024

Next review date : Monday, Sep 16, 2024 at 11 : 59pm (Pacific Time)

Apply by this date to ensure full consideration by the committee.

Final date : Monday, Nov 25, 2024 at 11 : 59pm (Pacific Time)

Applications will continue to be accepted until this date, but those received after the review date will only be considered if the position has not yet been filled.

Position description

Job Type

Academic - Non-Tenure Track

Job Summary

UC Berkeley Extension, the professional and continuing education division at the University of California, Berkeley, seeks dynamic part-time online course developers with a commitment to undergraduate, professional, and continuing education in Clinical Research, Regulatory Affairs, and Biotechnology to serve as subject matter experts in developing one or more online courses.

We are seeking online course developers who possesses current subject matter expertise and / or teaching knowledge in the following course subject(s) :

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)

Online Teaching Experience

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

General Duties

For each online course, the general duties include but are not limited to :

• Redevelop / refresh an existing asynchronous online course and / or develop a new asynchronous online course.
• Collaborate with the academic department and Instructional Design Team on course design, roadmap and framework and determine the number of course modules for each course.
• Collaborate with Academic Department, Instructional Designer and Media Team to create a media plan for the course.
• Collaborate with the Instructional Design Team on design of learning activities and learning strategies.

For each course module, develop and provide original raw content for the following common elements :

• Learning Objectives;
• Online course topic outline and syllabus;
• Lecture segments, including but not limited to video, PowerPoint slides, and audio recordings using University-provided software;
• Narrative textual content;
• Reading assignments;
• Learning Activities, including but not limited to discussion prompts, quizzes, assignments with instructions; and
• Assessments, including course midterm or project and two final exam versions with answer keys or a final project.

Produce course media with direction and collaboration from the academic department and Instructional Design Team :

• Write scripts for all media two weeks prior to recording
• Recordings
• Provide imagery examples or descriptions for each script to produce media

All duties are performed remotely. Meet weekly or biweekly (twice a month) with the Instructional Designer over zoom.

Review completed course content within LMS and provide content quality assurance including media content.

Clinical Research, Regulatory Affairs, and Biotechnology Courses : https : / / extension.berkeley.edu / academic-areas / sciences-and-biotechnology / #!?

programStream Life%20Science%20Business%20and%20Biotechnology

Qualifications

Basic qualifications

required at time of application)

Advanced degree

Additional qualifications

required at time of start)

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.

Preferred qualifications

• Doctorate degree or equivalent international degree in clinical research, regulatory affairs, biotechnology, or related field.
• 3 or more years of professional and / or academic experience in clinical research, regulatory affairs, biotechnology, or related field.
• 3 or more years of professional or undergraduate-level teaching experience (as the primary instructor).
• Experience teaching at a U.S. college / university institution.
• Experience teaching and / or developing academic content for online courses.
• Experience in creating original academic content such as syllabi, learning objectives, lectures / presentations / scripts, learning activities, assignments, assessments, exams, and quizzes.
• Ability to convey conceptual and complex ideas and information.
• Ability to collaborate with colleagues and work within a team environment.
• Ability to commit time to approximately 10-15 hours a week over 6-9 months (specific delivery schedule determined by mutual agreement).
• Ability to participate in regular phone / video conferences M-F between 9am-5pm (USA Pacific Time).
• 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).

• Effective verbal / written communication and presentation skills (English).
• Effective organizational skills with attention to detail.

Application Requirements

Document requirements

Curriculum Vitae - Your most recently updated C.V.

Cover Letter

Reference requirements

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

Apply link : https : / / aprecruit.berkeley.edu / JPF04551

Help contact : [email protected]

About UC Berkeley

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.

Job location

Berkeley, California, U.S.A.