Purchase contact hours here
Speaker:
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Sophy Yohannan, MMBS, CCRC – Clinical Research Associate, II, Boston Scientific
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Sergey Nikitin, BSc, MBA, President and Director, Prime Site Research Solutions Inc.
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Jessica Pinder, BSc, CCRP, PMP, Project Manager, Prime Site Research Solutions Inc
Program Agenda:
- 8:45-9:00 am Virtual Sign-In
- 9:00-11:00 am - Presentation of Recorded Sessions
Program Description:
“Building Relationships & Collaboration: Sponsors and Sites”
Sophy Yohannan, MMBS, CCRC – Clinical Research Associate, II, Boston Scientific
Description: How would you describe your CRC-CRA relationship? Do you see opportunities to improve your communication and collaboration? Then this webinar is for you! We invite all CRCs, CRAs, Project Managers, Regulatory Liaisons, and other study personnel to join this webinar for a review of our responsibilities and a discussion of these relationships. Feedback from high performing sites on strategies for collaboration and relationship building will be shared and open forum for discussion provided.
Learning Objectives:
- To review Sponsor and Site Responsibilities as outlined by FDA and ICH
- Define common goals and pain points
- Discuss feedback from high-performing sites and brainstorm methods to improve relationships and collaboration moving forward
“How to Create a Culture of Quality at Research Sites”
Sergey Nikitin, BSc, MBA, President and Director, Prime Site Research Solutions Inc.
Jessica Pinder, BSc, CCRP, PMP, Project Manager, Prime Site Research Solutions Inc.
Description: Sites are busy and often overlook quality assurance (QA) and only focus on QA when issues arise or when faced with an audit. This presentation will describe our experience creating a culture of quality using an integrative approach in a team.
Learning Objectives:
- After the presentation, participants will be able to take ownership of their culture of quality using practical tools and advice. Participants will have practical tools to help their site own quality.
- Participants would better understand quality assurance and its challenges.
- Participants will be able to use info presented to implement site quality management system.
Target Audience:
- CRCs
- CRAs
- Investigators
- Auditors
- Project Managers
- Regulatory Affairs/Compliance
- Data Managers (Site, Sponsor, CRO)
- Medical Monitor, Medical Officer, Project Physician
- Quality Assurance
- Clinical Research Administrators
Contact hours: 2.0 Contact hours have been applied for through ACRP.
Membership is not required for online registration of contact hours.
To receive contact hours: Purchase the contact hours, sign in at the event, and attend the program. Log on to the ACRP website then “My Courses” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Contact Hour Cost:
- $0 Chapter Members
- $15 ACRP Members
- $30 Non-Members
Registration Cost:
- $5 Chapter Members
- $5 ACRP Members
- $5 Non-Members
Refund Policy: Not applicable
Level: Basic to Intermediate