The course will take place on Friday, November 4, 8-9:30 am, Friday, November 11, 8-10:00 am, and Friday, November 18, 8-9:00 am. Breakfast and coffee will be provided. You must apply to participate.
In the class, Shraddha Desai, PhD (former Duke postdoc and president of DUPA; current Project Specialist II, Clinical Project Management, INC Research) will discuss the principles and practice of clinical trials management.Topics to be covered include:
- Clinical operations and trial management
- Drug discovery and development
- FDA regulations, ICH-GCP guidelines, IRB requirements
- IND applications
- Clinical trials career paths and career progression
Speaker: Shraddha Desai, PhD, is Project Specialist II, Clinical Project Management, at INC Research, where she works on Oncology and HemOnc Clinical Trials. Shraddha is experienced in all aspects of clinical trial project management processes including developing project plans; regulatory authority submissions; site and study management; budget management; investigator recruitment and feasibility; safety; TMF reviews and audit preparation; and supporting medical monitoring and patient recruitment teams. Shraddha received her PhD in Biochemistry from the University of South Florida and did a postdoc in the Duke University Department of Medicine-Oncology. Shraddha is past President of the Duke University Postdoctoral Association (DUPA) as well as past President of the Graduate Women in Science (GWIS) RTP chapter.
Application Instructions: Email a bio and brief statement explaining why you are interested in this course (no more than 2 pages total) to firstname.lastname@example.org and email@example.com. Class size limited to 20; please do not apply unless you can commit to attending all of the sessions! Deadline to apply: Mon Oct 24, 12 noon. Questions? Email Molly Starback, Director of Duke Postdoctoral Services, at firstname.lastname@example.org
LocationNanaline Duke Building, Room 252-B Map and Directions
- Professional Development