No prior experience is required to begin the certificate, but a bachelor's degree is recommended, preferably in a science or technical field. The curriculum is designed to provide foundational and advanced knowledge for individuals entering the field as well as for professionals seeking to expand their expertise.
The Certificate Program in Clinical Research Conduct and Management is designed for individuals seeking to enter or advance in clinical research careers, including clinical research coordinators, clinical research associates, research assistants, healthcare professionals, nurses, life sciences professionals and recent graduates interested in the clinical research field.
Yes. Many students enter the program from health care, public health, biotechnology, pharmaceuticals, laboratory sciences and other related fields. The certificate provides a strong foundation in clinical research principles, regulations and operations to support a career transition into the industry.
This program prepares students for a variety of roles within the clinical research industry, including clinical research coordinator, clinical research associate, clinical trial assistant, research assistant, study coordinator and other positions supporting clinical trial operations, compliance and research management. Career opportunities vary based on an individual's education, experience and professional background.
Students develop knowledge and practical skills in clinical trial design, Good Clinical Practice (GCP), regulatory compliance, FDA regulations, protocol development, clinical operations, data management, research ethics, quality assurance and project management.
Yes. All courses in the Certificate Program in Clinical Research Conduct and Management are offered in a fixed-date format online, providing flexibility for working professionals and students located throughout the United States and internationally.
Yes. Many students complete the certificate while working full time. Courses are offered online in a fixed-date format, allowing working professionals to balance their studies with personal and professional responsibilities.
Students have up to five years to complete the certificate requirements. Most students complete the program within one to two years, depending on their course load and schedule.
No application is required. Students may register for the certificate program at any time. A one-time, nonrefundable certificate registration fee is required to declare your intention to complete the curriculum and earn the certificate.
While courses are not required to be taken in sequence, the curriculum is intentionally designed so that each course builds upon concepts introduced in previous coursework. Students are strongly encouraged to begin with Introduction to Clinical Research: Clinical Trial Phases and Design.
Courses are offered throughout the spring, summer and fall terms. Course schedules may vary by term. Please visit the program webpage or contact biotech_online@berkeley.edu for the most current schedule information.
The program provides foundational knowledge in clinical research regulations, operations and best practices that supports preparation for professional certifications offered by organizations such as the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SOCRA).
The certificate program includes 180 instructional hours, and students may apply these hours to replace a portion of the total work experience hours needed to meet eligibility requirements to apply for the Certified Clinical Research Professional Certification by the Society of Clinical Research Associates (SOCRA). Students may also opt to apply course credit from this certificate program toward maintenance of their certification through the Association of Clinical Research Professionals (ACRP) organization.
Certification eligibility and maintenance requirements are established by the certifying organizations and are subject to change. Students should review current requirements directly with ACRP and SOCRA.
Demand for skilled clinical research professionals continues to be driven by growth in biotechnology, pharmaceuticals, medical devices and healthcare innovation. Employers increasingly seek professionals with knowledge of clinical trial operations, regulatory requirements and data management and Good Clinical Practice (GCP).
Clinical research coordinators typically manage study activities at research sites, including participant recruitment, study visits and regulatory documentation. Clinical research associates generally work for sponsors or contract research organizations and monitor research sites to ensure compliance, data quality and protocol adherence.
Students learn from instructors who are experienced industry professionals and engage with classmates from a variety of professional backgrounds. These interactions provide opportunities to build professional connections and gain insights into current industry practices. UC Berkeley Extension also maintains a LinkedIn community that allows students and program completers to connect with peers, instructors and staff.
The program does not provide internship or job placement services. However, students gain industry-relevant knowledge and skills that can strengthen their qualifications for clinical research positions. Networking with instructors and peers may also support career development opportunities.
While our students are not eligible for federal financial aid programs related to FAFSA, students may consider private education loans. More information about financial assistance options is on the website.
If you have any additional questions or would like to learn more about whether the Certificate Program in Clinical Research Conduct and Management would be a good fit for you, please email us at biotech_online@berkeley.edu. In addition, you may also attend an online information session to learn more about the curriculum, career pathways and student experience and to ask staff questions in real time.