Identification: 5056
Credits: None available.
Identification: 145
Credits: None available.
In this session, we will explore how to create depth in a Clinical Research Team, a problem which is often faced by Clinical Research sites. Please join Dr. Suzanne Rose as she shares her insight and knowledge on how to create a broad range of research positions on any size clinical research team. In this session, you will learn about best utilizing each team member to their fullest capacity and how to be creative in job sharing and maximizing performance from each team member. Come to this session to learn how to think outside of the box of the typical clinical research team members' defined roles and responsibilities and how to best align your team with your department and organization's goals. In this session, you will have the opportunity to learn about unique job descriptions as well as be provided with justifications for each role. The audience will have full access to job descriptions as well as hiring justifications for these roles as well as tips how to work with your leadership and human resource committee to ensure success in obtaining new hires.
Identification: 117
Credits: None available.
Identification: 5000
Credits: None available.
Join this exciting overview on how the pandemic forced many into decentralization of the site and the effects of site cash flow, workforce safety and increased flexibility. How can we all (Sponsor/CRO/Site) help each other through these challenges and how we as a workforce can maintain compliance while working in a remote environment.
Identification: 132
Credits: None available.
Identification: 124
Credits: None available.
Identification: 5005
Credits: None available.
Identification: 5062
Credits: None available.
Please join David Burrow from FDA's Center for Drug Evaluation and Research as he discusses key opportunities for the clinical research industry to make their FDA inspection experience a positive one. Dr. Burrow will outline the impact inspections have on marketing applications, and will identify key strategies to build quality into clinical research in order to prevent critical compliance issues. When problems do occur, inspected entities should be able to respond appropriately. In this session, you will be able to take away practical approaches to working with the FDA during an inspection, responding to 483s after an inspection, and responding to subsequent regulatory correspondence.
Identification: 123
Credits: None available.
Identification: 5004
Credits: None available.