Certificate in Biotechnology
Clinical Trial Design & Management
I was recently hired for a position with a Bay Area biotech company as the Clinical Information Manager of Investigator-Sponsored Trials, in the Medical Affairs group.
I'm really excited about my new position, and I'm convinced that had I not taken any Clinical Trials classes, I would not have been considered for the job.
I'm thrilled that the program helped me get into the industry. It will be really nice to be able to immediately relate the lectures to my day-to-day work, and I also feel it's important for me to continue taking classes, not only for my professional growth and to complete the certificate, but to also be part of a support network of instructors and fellow students.
- Brenda H., Clinical Trials Student, Fall 2005
Clinical Trials Design & Management
Certificate Graduation Application
Download the application below:
Clinical Trials Design & Management
Certificate Requirements
There is no application to begin this program. Students may take classes individually to enhance their personal goals or complete a full certificate. A certificate of completion will be awarded upon successful completion of a minimum of ten classes, including all required courses and a choice of electives, totaling a minimum of 180 hours (18 CEUs). The total cost of the program depends on the electives chosen. Course fees are listed with each course in the catalog and online. Course materials are included in the course fees. Certificate requirements must be completed within a three-year period.
Applications for Certificate of Completion are due, along with a $50 non-refundable fee and an unofficial transcript once all courses have been completed and grades have been posted. Mail all completed applications/transcripts to the Downtown Campus, attention Dylan Romero.
If you have questions, contact program coordinator Dylan Romero at dromero2@sfsu.edu.
Enroll Early
To ensure you will receive course materials at the first class meeting, please enroll at least three weeks before the class begins. Students enrolling on the first day of class will be subject to late registration fees. See Fees & Refunds.
Policies
See Extended Learning Information & Policies and Fees & Refunds.
Clinical Trials Design & Management Curriculum
Take the seven required classes and electives to complete the minimum of 180 hours (18 CEUs).
Required Courses:
- Medical Terminology
- Introduction to the Clinical Trials Process
- Good Clinical Practices
- Clinical Trials Monitoring
- Clinical Trials Design
- Clinical Data Management
- Biostatistics
Electives:
- Adverse Events
- Ethical & Legal Issues in Clinical Trials
- Case Report Form Design
- Compliance Audits & FDA Inspections
- Quality Compliance GXP
- Regulatory Processes & Issues
- Clinical Operations: Study Start-up
- Clinical Operations: Study Conduct
- Clinical Operations: Study Close-out
- Medical Devices: Regulation & Development
- 21 CFR Part 11 (Online)
About Classes
Medical Terminology, Introduction to the Clinical Trials Process, and Good Clinical Practices are the prerequisites for all other classes. Students with proven experience may test out of Medical Terminology by contacting Dylan Romero to set up a test appointment.
Please note: Dates subject to change
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