Full course description
The Georgia Clinical & Translational Science Alliance- Georgia CTSA andSC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.
An overview of the resources and infrastructure required to successfully operate industry-sponsored, grant-funded, and investigator-initiated clinical trials at an academic medical institution will be discussed.
- Clinical trial life cycle
- Categories of clinical trials performed in academia
- Federally funded
- Successful clinical trial requirements
- Contract and budget
- Regulatory oversight
- FDA: Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH)
- Institutional Review Board (local vs. central)
- Specialty Committee: Biosafety, Radiation Safety
- Regulatory Compliance Requirements
- Safety Oversight: Data and Safety Monitoring Plan
- Resources and infrastructure
- Investigator-initiated trials
- Data management
- Multi-site management
- Academia organizations
- Regulatory affairs unit
- Clinical research operations unit
- Administration business management unit
- Facilities and equipment
- Investigator-initiated trials
Zeno Ashai, MBBS, MPH is the Associate Director of the Clinical Investigations Support Office (CISO) at the USC Norris Comprehensive Cancer Center (NCCC). Mrs. Ashai dedicated over 15 years in oncology clinical research, 13 years of which have been in complex, multi-layered academic environment of the NCI-designated cancer center. Mrs. Ashai has worked in the pharmaceutical industry as Director of Clinical Operations with special focus in oncology in US, India, and Latin America, successfully advancing two oncology compounds through Phase I and II clinical trials. As part of her role, Mrs. Ashai was managing U.S. investigational sites and central laboratories as well as Global CROs, interfacing with FDA, local regulatory and clinical entities to ensure compliant and timely conduct of clinical trials. In 2010 Mrs. Ashai joined the USC NCCC CISO leadership team as Assistant Director for Regulatory working within a multidisciplinary team to further expand the regulatory and PRMS programs. In 2019 Mrs. Ashai was promoted to Associate Director of CISO where she now leads CISO Clinical Research, Regulatory, Business Administration and QA teams ensuring safe and compliant implementation of Phase I, II and III oncology clinical trials conducted at USC. Her areas of expertise include management and implementation of clinical trial operations, quality assurance, FDA regulations, regulatory compliance, and development and implementation of operating policies & procedures for conducting clinical trials in academic setting. She completed medical school at Fatima Jinnah Medical College in Pakistan followed by residency training and holds a Master’s degree in Public Health Administration and Policy from the University of Minnesota. email@example.com
Learner Level: Beginner/Intermediate/Advanced
Audience:This symposium is designed for Clinical Research Assistant/Associates or Clinical Research Coordinators in academia, clinics, hospitals, industry, or CRO with 1- 2 years of clinical research experience. Individuals may be new to clinical research with limited knowledge of clinical trial conduct, good clinical practices, regulations and common terminology associated with clinical research.
Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Credentialing Center’s Commission on Accreditation. Attendees to this CNE activity will be awarded 0.75 contact hours by ENPDC. No conflict of interest has been found with the speaker for this CNE activity nor with the members of the planning committee.
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Program Information: This is the third course in a five (5)-course program. To complete the entire program and earn a badge CLICK HERE.