This five day intensive course provides a solid foundation in the principles upon which clinical trials are based. Topics include: drug development process, device development, GCPs (ICH and FDA), Case Report Form design, investigator selection, IRBs/informed consent, trial design & protocol, site and study management, monitoring, regulatory issues, and data analysis.
Other Credits: BRN: 40 CE hours
Note: Intensive Workshop may be taken alone, or as Part 1 of Specialized Certificate in Clinical Trials Administration. Part 2 includes three online courses and a follow-on workshop. Contact Debbie Ortuño at firstname.lastname@example.org for more information on the Specialized Certificate program.
The spring 2023 course starts with a 5-day Intensive Workshop: Monday – Friday, 4/03/23 - 4/07/23, via live Zoom format. (8:30 a.m. to 4:30 p.m. PST).
Course Number: FPM-40273
Credit: 4.00 unit(s)
Related Certificate Programs: Clinical Trials Administration
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4/3/2023 - 4/7/2023
Synchronous web-based class meetings that are scheduled to meet online at published times (time/date).
Agee, Jan, Training Manager and Instructor for Quintiles, Inc
Jan Agee is a clinical trials consultant currently assisting an academic institution organization in conducting Food and Drug Administration-focused clinical trials. With over 30 years of industry experience, Agee has expertise in pre-clinical and clinical drug and device development.
Her background includes clinical operations implementation across all phases of drug development, good clinical practice training and implementation. Her previous position was with a global contract research organization where she taught good clinical practices to new and experienced clinical, project management, medical and regulatory staff. Agee's prior experience also includes more than 13 years as a clinical research monitor (CRA) for numerous pharmaceutical companies across ind...Read More
Paredes Solis, Jenny, Senior Manager, Clinical Operations, PRA Health Sciences
Jenny Paredes has been working in clinical research for over 20 years. She currently provides Clinical Consulting in Clinical Research for companies in Latin America and the USA. She worked in the CRO environment for 14 years where she held various roles as CRA, LCRA, CTM/PM, Clinical Operations Manager and Country Lead.
She has experience working on Phase I-IV studies in multiple therapeutic areas. Additionally, she has vast knowledge in Monitoring, Regulatory, and Quality, which she is passionate about.
Jenny holds a B. A, M.A and Ph.D in Psychology from Atlantic University in Hawaii as well as an Associate’s Degree in Medical Health Science from Mount St Mary's College in Los Angeles CA.
Some of her various hobbies include traveling, reading and going to the...Read More
No refunds after: 4/3/2023.
Part 1 of 2 parts of certificate program. Second part:
section 170727, which includes three online classes and
an in-class two-day workshop on June 15 & 16, 2023.
The spring 2023 program will be offered remotely, via l
ive Zoom format.
There are no sections of this course currently scheduled. Please contact the Healthcare & Behavioral Sciences department at 858-534-9262 or email@example.com for information about when this course will be offered again.