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Clinical Research Conduct and Management Certificate Information Session
- 1. extension.berkeley.edu Clinical Research Conduct and Management Certificate Online Information Session
- 2. extension.berkeley.edu Hello Richard Louie, Ph.D., FACB Program Director Ask me your questions! 2
- 3. extension.berkeley.edu The Clinical Research Landscape The need for professionals like you! 3
- 4. extension.berkeley.edu About Clinical Trials 4 ● Investigate whether a medical strategy, treatment or device is safe and effective for humans. ● Determine which medical approach works best for certain diseases or groups of people. ● Produce best data available to enable evidence-based health care decision- making.
- 5. extension.berkeley.edu Example Careers in the Clinical Research Profession 5 ● Clinical Research Associate ● Clinical Research Coordinator ● Biostatistician ● Clinical Quality Assurance Auditor ● Drug Safety Monitor ● Regulatory Affairs Specialist ● Medical Writer
- 6. extension.berkeley.edu Example Careers in the Clinical Research Profession 6 ● Clinical Research Associate ● Clinical Research Coordinator ● Biostatistician ● Clinical Quality Assurance Auditor ● Drug Safety Monitor ● Regulatory Affairs Specialist ● Medical Writer
- 7. extension.berkeley.edu Clinical Research Associate—Defined 7 A CRA supervises, monitors and supports the administration and progress of a clinical trial on behalf of a sponsor. The sponsor, whose intent is the research of pharmaceuticals, biologics or devices—may employ these individuals either directly or indirectly via contract research organizations (CROs) or as independent consultants or contractors. Association of Clinical Research Professionals (acrpnet.org), Aug. 2, 2016.
- 8. extension.berkeley.edu Clinical Research Associate—Roles and Responsibilities 8 1. Serve as the liaison between the site investigator conducting the clinical trial and the sponsor. 1. Monitor clinical site activities, ensuring compliance with clinical trial protocol. 1. Make on-site visits, review case report forms and ensure scientific integrity of data. 1. Assure the protection of the subjects’ rights, safety and well-being. 1. Ensure adverse events are correctly documented and reported. 1. Communicate with clinical research coordinators.
- 9. extension.berkeley.edu 9 Job Title Clinical Research Associate I (Entry Level) Clinical Research Associate II Median Annual Salary $70,391 $83,820 Salary Range $61,916–$77,784 $72,534–$96,275 Clinical Research Associate III $110,955 $95,670–$130,595 Clinical Research Coordinator (Entry Level) $73,274 $62,928–$84,652 Clinical Research Manager $118,834 $101,814–$137,038 Salary Range in the San Francisco Bay Area Salary.com, Aug. 31, 2017
- 10. extension.berkeley.edu How to Become a Clinical Research Associate 10 Bachelor’s degree (Recommended in a science or technical field) Build core knowledge on clinical research (Clinical Research Conduct and Management certificate) Participate in internship/practicum to gain hands-on experience Expand work experience Credentialing examination (CCRA, CCRC or CCRP)
- 12. extension.berkeley.edu 12 Certificate Program in Clinical Research Conduct and Management
- 13. extension.berkeley.edu 13 What You Learn Average Time to Completion: ~1 year 4 Required Courses Introduction to Clinical Research: Clinical Trial Phases and Design Clinical Trial Planning: Protocol Development, Data Management and Clinical Site Activities Clinical Trials Implementation: Site Initiation, Subject Recruitment, Monitoring and Safety Reporting Clinical Trial: Data Analysis, Regulatory Audits, Vendor Selection and Project Management
- 14. extension.berkeley.edu Where You Learn: In the Classroom 14 San Francisco Campus in Downtown San Francisco
- 15. extension.berkeley.edu Where You Learn: Online 15 How You Learn ● Reading materials ● Videos ● Podcasts ● Instructor and classmate interactions ● Homework assignments ● Proctored final exam Fixed-Date Start and end date Hybrid 50-percent classroom instruction 50-percent online instruction
- 16. extension.berkeley.edu Getting Started 16 Bachelor’s degree recommended Pay for each course individually ($1,975 each) Pay registration fee of $150
- 17. extension.berkeley.edu Earning Your Award of Completion 17 Create free online student account Start with Introduction to Clinical Research; complete remaining 3 courses Complete courses with grade of C or better; achieve a GPA of 2.5 or better Receive certificate Register for the program and pay fee
- 18. extension.berkeley.edu 18 Expand Your Knowledge! Courses of Interest ● Drug Development Process: An Intensive Seminar ● Pharmacology ● Genomic Medicine ● Principles of Toxicology ● Introduction to Biostatistics ● Principles of Regulatory Affairs ● Principles of Quality and Compliance
- 19. extension.berkeley.edu 19 Internship Opportunities Gain Work Experience. Build Connections. Expand Your Network. ● Stanford School of Medicine Clinical Research Preceptor Program ● Industry Programs: biopharmaceutical, medical device and in vitro diagnostics
- 20. extension.berkeley.edu Who You’ll Learn From 20 Marianna Lenoci, M.A. Regulatory Compliance Gilead Sciences Inc. Karim Sajwani, M.P.H., CCRA Senior Clinical Program Manager Gilead Sciences Inc. Bonnie Miller, M.S., RN Clinical Research Consultant ACRP President, Northern California Chapter Munaza Jamil, CCRA, CCRP Clinical Trials Manager North York General Hospital Radhika Sivaramakrishna, Ph.D., PMP, CCRP, Senior Director, Clinical Finance and Operational Excellence Dynavax Technologies David Leonard, DHSc, MMS, PA PA Educator and Clinical Research Consultant University of Birmingham Daniel Redline, CCRP Director, Clinical Affairs NeuroVision
- 21. extension.berkeley.edu Our graduates go on to do big things! 21
- 22. extension.berkeley.edu A look at where some of our graduates end up: Jennifer Brandl Associate Manager, Clinical Trials at Immune Design Marcella Fasso Clinical Scientist at Genentech Joyce Nortey Project Manager at Nektar Therapeutics 22
- 24. extension.berkeley.edu 24 Thanks! Find me at biotech_online@berkeley.edu (510) 642-1062 extension.berkeley.edu/cert/clinical.html
Editor's Notes
- Hello, this is Dr. Richard Louie at UC Berkeley Extension, and Welcome to the Informational Session on the Certificate Program in Clinical Research Conduct and Management. In the next 20-30 minutes I will share with you information about UC Berkeley Extension, the Professional Certificate Prorgram in Clinical Research Conduct and Management, a programmatic overview, how to earn the certificate, other programs of interest and then conclude with a question and answer segment.
- Richard, do we have any information about the job growth/opportunities post-certificate?
- Screen needed?
- Richard, do we have any information on types of positions post-certificate?
- Richard, do we have any information on types of positions post-certificate?
- Screen needed?
- Screen needed?
- Is this screen needed?
- Now how can UC Berkeley Extension help you achieve this career goal? When you enroll in a UC Berkeley Extension course, you are guaranteed a real-world professional education, and on top of that, you’re also getting Berkeley-quality education—without the application process or student loan! UC Berkeley Extension is the continuing education college of UC Berkeley and we’ve been assisting students in reaching their professional goals since 1891. Currently, we offer more than 65 professional certificates and specialized programs, and more than 2,000 classroom and online courses and 38,000 enrollments each year. We pride ourselves on academic excellence. All of our courses and certificates—such as this Clinical Research certificate—are approved by the appropriate main campus department. You can take a course online or in the classroom. Our classroom courses are available at our Berkeley, San Francisco, and Belmont facilities. Our courses are UC Berkeley approved and instructors carefully vetted with extensive teaching and academic experience. The advisory board comprises life-science and education leaders and working professionals with the respective disciplines.
- The Clinical Research Conduct and Management Certificate program is designed to provide the foundational knowledge that will help prepare you for a career in clinical research. The program covers a number of topics including study design, the regulatory agencies. Good clinical practices. The program also covers the operational aspects of planning and implementation clinical studies. Data Management. Human Subjects Research/Informed Consent, Project management, Data management and Analysis, and Study closeout – clinical study report. This program is suitable whether you pursue a career in academic research institutions, diagnostic/therpeutic companies, or contract research organizations. This professional certificate was first introduced in 2004 and we have awarded over 600 certificates to date. For this program, we recommend that you have bachelor’s degree, preferably in the science or technical field. The curriculum/coursework meets the continuing education requirements for nurses and clinical research professionals.
- These are the four courses that you will need to complete the certificate. We recommend that students complete the courses in the order of the sequence, as subsequent courses builds upon the prior course. For example, here are some of the topics covered in the first course (X400.2) Introduction to Clinical: Clinical Trial Phases and Design. This first course covers Good Clinical Practice, Regulations (FDA, ICH), Clinical Trial Design, Medical Devices, and Medical Terminiology, among other topics In the second course (X400.3), we cover topics including Clinical Trial Protocol Development, Data management, Data Capture,, Informed Consent, operational elements in the planning and initiation of clinical studies. The third course (X400.4) covers, topic including regulatory documents, clinical trial implementation, study monitoring, subject recruitment The last course covers topics including quality assurance, inspections and audits; project management, data analysis, and clinical study report Students typically complete the program within a year.
- We offer all of the four courses in each academic term (Spring, Summer and Fall Term) Each course is available in two delivery formats, we offer online and hybrid formats. I’ll discuss about the two formats in the next two slides. Whether you elect to complete the courses in online or hybrid format,… the courses are interchangeable, meaning you could complete the certificate program with a combination of hybrid and online courses. You can complete the program by completing all the courses in the hybrid format, or online, or taking some courses in the hybrid and the rest online. I like to take a moment to describe the difference between the different course delivery options. The hybrid courses consist of 50 percent classroom and 50% online instruction. Hybrid course consists of 4-5 in-person Saturday meetings. Hybrid course allow for students wishing in-person interaction with instructors and peers. The hybrid courses are held at our San Francisco teaching facility. Classroom courses also referred to hybrids in this program are offered in Fall and Spring Semesters. Online courses are offered in Fall, Spring and Summer semesters. Fall semester starts late-August to December Spring semester spans from January to April Summer from May to August. The hybrid format delivery consists of a mixture of online and in-person classroom instruction. About 50% of the course instruction involves online course material and 50% in-person classroom instruction. Our hybrid courses are held at the San Francisco teaching facility. For hybrid courses, students meet on 4 to 5 Saturdays for a full-day classroom instructions, including lectures, assignments, case studies, and exercises. Students are assigned learning modules to complete prior to the next class meeting. The course typically is over a two month period.
- For the online delivery, course materials, learning modules, assignments, and discussions are completed entirely online. Online courses are fixed date, meaning there is a defined start and end date. Online courses are 8 weeks in duration, with assigned weekly modules and associated written and discussion assignments. Both our classroom/hybrid and online course instructors are industry professionals in the management and conduct of clinical studies/clinical trials. There is a define start and end date for our online course. The course instructor will provide a course calendar to define due date for assignments and when each learning module should be completed. A proctored final exam is required for the online format. In the hybrid format, the final exam is taken on the last class meeting.
- Entering the prep program we reocmmend that you have completed a Bachelor’s Degree, preferably in Biology or Chemistry. You pay for courses as you enroll in them. The course fees varies but for 3 unit courses, the course fee is $975-1050 per course. Registration for the preparatory program is a one-time $100 processing fee. The benefits of registering for the program includes: Notification of program updates Notification of courses And an AWARD of Completion (Certificate)
- To earn the certificate: You need to register for the certificate and complete the four-required courses with a C or better. You may register for the certificate even after you have started taking the courses. Once you have complete the course work, please contact our department (SMB) to requrest the certificate. We will have the program contact number at the end of the presentation.
- These are the four courses that you will need to complete the certificate. We recommend that students complete the courses in the order of the sequence, as subsequent courses builds upon the prior course. For example, here are some of the topics covered in the first course (X400.2) Introduction to Clinical: Clinical Trial Phases and Design. This first course covers Good Clinical Practice, Regulations (FDA, ICH), Clinical Trial Design, Medical Devices, and Medical Terminiology, among other topics In the second course (X400.3), we cover topics including Clinical Trial Protocol Development, Data management, Data Capture,, Informed Consent, operational elements in the planning and initiation of clinical studies. The third course (X400.4) covers, topic including regulatory documents, clinical trial implementation, study monitoring, subject recruitment The last course covers topics including quality assurance, inspections and audits; project management, data analysis, and clinical study report Students typically complete the program within a year.
- These are the four courses that you will need to complete the certificate. We recommend that students complete the courses in the order of the sequence, as subsequent courses builds upon the prior course. For example, here are some of the topics covered in the first course (X400.2) Introduction to Clinical: Clinical Trial Phases and Design. This first course covers Good Clinical Practice, Regulations (FDA, ICH), Clinical Trial Design, Medical Devices, and Medical Terminiology, among other topics In the second course (X400.3), we cover topics including Clinical Trial Protocol Development, Data management, Data Capture,, Informed Consent, operational elements in the planning and initiation of clinical studies. The third course (X400.4) covers, topic including regulatory documents, clinical trial implementation, study monitoring, subject recruitment The last course covers topics including quality assurance, inspections and audits; project management, data analysis, and clinical study report Students typically complete the program within a year.
- Note: Can add slide re: instructors if you want
- Students have found this program to be very beneficial to helping them secure their job as a clinical research professional.
- We’ll use your FAQs as “real incoming questions” so that students get the feeling that this presentation is live.