Clinical Trials Project Management ONLINE Courses
Meeting the High Demand for Project Management Personnel for the Human Clinical Trial Process
The Clinical Trials Project Management (CTPM) courses are graduate level academic online credit courses. These four courses are designed to meet the high demand for project management personnel for human clinical trials involving medical devices, in vitro diagnostics, biologics, pharmaceuticals and combination products, with the focus on managing biomedical product development for FDA approval.
The courses are ideal for professionals interested in pursuing a clinical development career. They are designed to help clinical research associates, health care and allied health professionals and professionals involved in the development of a medical product to refine their skills or expand their knowledge. The online format allows for a more flexible schedule for those already in the workforce. Even though the class takes place outside of the traditional classroom, the courses offer real-world experiences involving team projects and case studies.
The four courses incorporate several overall themes: project management, ethics in biomedical product development, data management and global regulatory affairs.
Each CTPM course consists of 3 units of credit; students completing all 4 courses will receive a California State University Certificate Program in Clinical Trials Project Management and 12 units of academic credit.
Download a program information sheet.
Program Benefits
- Learn the process for managing biomedical product development for FDA approval
- Gain an in-depth understanding of the clinical trials process through a modular, operations-focus approach
- Acquire project management skills needed to successfully manage human clinical trials
- Gain a global perspective on clinical trials management to better respond to the growing industry across the globe
- Learn how to respond to ethical issues inherent in clinical trials
- Discover how to use statistical methods to monitor clinical trial outcomes and make decisions
- Gain practical knowledge through real-world case studies and team projects in product development
- Learn from instructors with industry expertise in clinical trials management
SCHEDULE
Please contact Pat Lussier, plussier@fullerton.edu for future offerings.
COURSE DESCRIPTIONS
The first course is the prerequisite for the rest. The courses are listed in the order they will be offered. This is a cohort-based program – students will go through the four courses with the same group of students.
1) Introduction to Food and Drug Law - RA 602 (3 units)*
Please note: This first course will be offered online through San Diego State University but the three remaining courses will be offered online through Cal State Fullerton.
An overview of:
- Regulatory requirements in the U.S. for drugs, biologics, in vitro diagnostics, devices, combination products, dietary supplements and cosmetic products
- Regulations in other countries
- Food and Drug Administration's (FDA) organization, structure and history
- Medical product development process
- Good Clinical Practices (GCP) – standards and regulations, pre-market and post-market
- Requirements and best practices for post market clinical trials
- Ethical concerns and examination of the role of statistics in clinical studies
* This course is offered online through San Diego State University.
2) Clinical Trials Project Management: Setting Up Clinical Trials - BIOL 537 (3 units)
Prerequisite: BIOL 576 or RA 602 or equivalent
A comprehensive overview of:
- Types and phases of clinical trials
- Implementation of Good Clinical Practices (GCP)
- Development of clinical study documents
- Interactions with Institutional Review Board (IRB)
- Identification and qualification of study sites
- Insurance requirements and needs
- Statistical considerations in study design
- Ethical issues
- Setting up clinical trials globally
- Investigator and subject matter recruitment issues
- Inclusion and exclusion criteria
- Project management skills and best practices
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3) Clinical Trials Project Management: Managing Clinical Trials - BIOL 538 (3 units)
Prerequisite: BIOL 537
A comprehensive overview of project management issues such as:
- Successful management, monitoring and closure of human clinical trials
- Preparing for and managing regulatory agency audits
- Balancing business goals with ethical issues
- Managing regulatory and statistical issues related to data management
- Monitoring best practices, from a global perspective
- Maintaining a budget and schedule to meet business goals
- Crisis management and conflict resolution
4) Clinical Trials Project Management: Pre-Market Submission Process - BIOL 539 (3 units)
Prerequisite: BIOL 538
A comprehensive overview of the report process for pre-market submission to the FDA, such as:
- Development of timelines for submissions
- Project management principles followed by Regulatory Affairs professionals employed in the biomedical industry
- Incorporation of clinical data into product labeling
- Best practices for negotiating with regulatory agencies
- Ethical considerations
- Statistical issues in submissions
- Post-market clinical study scenarios.
- Global perspective on the premarket submissions process
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COST
The cost of the first course will be $522 per unit for a total of $1566. The remaining three courses will be $495 per unit, which totals $1,485 per course.
REGISTRATION PROCESS
If you have questions regarding these courses, please contact Pat Lussier at plussier@fullerton.edu.
FREQUENTLY ASKED QUESTIONS
What types of career opportunities are available?
Clinical researchers, biomedical engineers, health care and allied health professionals can benefit by getting the training they need to transition into clinical product development, specifically for products needing regulatory approval.
What are the eligibility requirements?
Students must have successfully completed an undergraduate degree; it is preferred that students have a Bachelor's degree in science or healthcare related field. Students must maintain a GPA average of 3.0 or above throughout all course work.
What are the course prerequisites?
Courses 2, 3 & 4 have prerequisites. For course 2: BIOL 537 Setting Up Clinical Trials the prerequisite is BIOL 576 (Regulatory Affairs for the Biotechnology Industry) or RA 602 (Introduction to Food and Drug Law) or equivalent. “Equivalent” can be comparable course work and/or industry experience. If you have questions about your eligibility please send an email outlining the comparable course work and/or work experience to David Dyer, PhD., Director, Program for Applied Biotechnology Studies (PABS), Dept. of Biology, College of Natural Sciences and Mathematics at Cal State Fullerton at ddyer@fullerton.edu.
What is the projected pattern of the courses?
The first course is a 10-week session. The other three courses will be offered in 8-week sessions, with a 1-week break between each course. All four courses can be completed in less than a year if taken continuously.
What confirmation of participation in the program will I receive?
At the conclusion of each course, students can access their University transcript to verify successful completion of a course.
Can these units be transferred to a master's degree program?
Credits earned may be applied toward a master's degree, depending upon program approval.
Who is the advisor for the Clinical Trials Project Management Courses?
David Dyer, PhD., Director, Program for Applied Biotechnology Studies (PABS), Dept. of Biology, College of Natural Sciences and Mathematics at Cal State Fullerton who can be reached at ddyer@fullerton.edu.
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What GPA must I maintain?
As with any graduate courses, you must maintain a GPA average of 3.0.
Is there any financial aid?
No financial aid is offered. Check with your employer – some offer tuition reimbursement programs. Check your company's website or federal financial aid websites for information. Since grades are assigned in these credit courses, they qualify for state/federal financial aid consideration. Educational loans are also available through private banks.
Can I get a refund if I decide to withdraw from the class?
Please check UEE's refund policy for online classes.
What are the equipment requirements needed for these courses?
Review this list of requirements to make sure that your equipment is adequate for these online courses.
Once I'm registered, how do I begin?
Once your registration is confirmed, you will receive an email with instructions in how to access the course. Students will have access to the course beginning the first day of each course.
I've never taken an online class, what can I expect?
TITANium (Moodle) LOG-ON INFORMATION
In order to access TITANIUM students will need log-on information. Log-on can be requested via phone to our Student Services staff at 657-278-2932.
Business hours (CALIFORNIA TIME)
M-Th 8 a.m. – 5:30 p.m.
Fri 8 a.m. – 5 p.m.
Sat 8 a.m.-12 noon
OR
714-741-9161 (CALIFORNIA TIME)
M-Th 8 a.m.-7:30 p.m.
Fri 8 a.m.-5 p.m.
Sat 8 a.m.-12 noon
Students who are successfully registered in the course will receive a fee receipt confirmation and a Welcome Letter from our Distance Education staff.
If you have not previously used a Moodle Learning Management System, it is highly suggested that you access one of tutorials to become familiar with the site: http://oasis.fullerton.edu/tutorials.aspx
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INDUSTRY ASSOCIATIONS
For other life science programs offered through the CSU, refer to www.csubiocompass.org
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