Jan 15, 12:00 PM - 01:00 PM (ET)
Suncoast Chapter: A Site Management Approach to Study Startup
Event Description:
Site Management Organizations (SMOs) sit at the critical intersection between sponsors, CROs, and research sites—but when roles are unclear, timelines stretch, quality suffers, and frustration rises on all sides.
This session pulls back the curtain on how high-performing SMOs accelerate study start-up while strengthening compliance, data integrity, and sponsor/CRO confidence. Using real-world examples, we will break down the core SMO functions—from study activation and regulatory oversight to budgeting, contracting, education, and CTMS management—and show how clear role delineation drives measurable operational gains.
Participants will walk away with proven quality improvement strategies, practical templates, and technology-driven workflows that reduce start-up delays, streamline communication, and elevate site performance across the trial lifecycle.
Speakers:
Charita Braker, RN, CCRC, ACRP-MDP, ACRP-PM
Manager, Clinical Research Education
HCA Healthcare Research Institute
Jessi Klinedinst, M.A.
Manager, Regulatory Affairs
HCA Healthcare Research Institute
Learning Objectives:
Understanding that site management organizations (SMOs) are essentially the bridge between the sponsor/contract research organization (CRO) and sites, we will demonstrate proven quality improvement practices used by SMOs to reduce start-up timelines. Roles discussed involve study activation, regulatory compliance, contracting and budgeting, clinical education, and clinical trial management system oversight. Participants will understand the function of each role and how the delineation of responsibilities improves site compliance, data quality, and sponsor/CRO satisfaction with a site's clinical trials. We will explore best practices using specific examples from real-world experiences, including technology use and templates covering communication, trial management, study and site specifics, etc.
Registration Information:
Click here to register before 1/15/26. Each attendee is required to have their own registration – only one registration per transaction.
Chapter Member: $0
ACRP Member: $15
Non-Member: $30
After registering, please visit the event's community page to find the login information or any additional event updates, and to communicate with the event organizer.
The educational portion of this event may be self-reported as 1 point toward an attendee’s Maintenance of Certification. These points are subject to review and acceptance by the Academy of Clinical Research Professionals in accordance with the criteria established. Attendees should keep a record of event participation in case they are randomly selected to participate in the maintenance verification process. The Chapter can provide a certificate of attendance upon request.
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