Developing CRAs as Site Study Managers

The person that has the most contact with the site is the Clinical Research Associate (CRA); they are the “face” of the sponsor, the purveyor of information, and the person that most influences the site’s performance on a study. In a sense, CRAs are the sponsor’s On-Site Study Managers. It is critical that this individual be in a position to positively reflect the sponsor and ensure the site performs to their full potential through training, knowledge, and support. CRAs must understand the data review process, but they must also havethe skills to train, mentor, and communicate with new and experienced site staff, and to navigate the path through challenging situations. In addition, the CRA needs to be equipped and prepared to communicate with the Principal Investigator (PI) and be able to support the site in recruitment efforts and the documentation process. A better understanding of adult learning techniques, unique and thorough approaches to recruitment and retention strategies, carefully developed and implemented communication plans, and an understanding of project management techniques can make the difference between a site meeting enrollment with minimal deviations, and a site lacking in enrollment with multiple protocol violations. This course will focus on a variety of techniques and training to help CRAs move from monitors to on-site study managers in their skills.

• Evaluate the role of the CRA as the first point of contact and expert on a study
• Explain the importance of live conversations with the site
• Demonstrate advanced monitoring and communication techniques for the challenging site
• Discuss techniques used in adult learning and how to best apply them to clinical research
• Facilitate techniques for preparing for and having conversations with Principal Investigators
• Describe advanced recruitment and retention activities to ensure the CRA is equipped to support the sites in recruitment efforts
• Explain how to develop a solid and reasonable recruitment action plan and how to support the evolution of this document throughout the trial
• Discuss information and support for an on-site study manager
• Evaluate various project management and tracking techniques to provide the CRA with a wealth of tools for managing multiple sites

• Managers of CRAs
• Senior, lead, or advanced CRAs
• Study Managers
• New CRAs looking to develop their skills

The course will be led by one of the following instructors:

Nikki Christison, B.S., C.C.R.A.
Beth Harper, B.S., M.B.A. 

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Day 1: 8:30 a.m. – 5:00 p.m.

• Introductions
• The CRA as a Study Manager
• Regulatory Guidance Documents and Updates: Discussion, Overview and Knowledge Checks
• Risk Based Monitoring: Discussion and Overview
• Case Study on 1572: Hands on Activity
• Proactive Site Management - Managing Challenging Situations
• "Red Flag" Identification: Hands on Activity
• Communicating Effectively with Investigators
• Definition of Roles and Responsibilities: Hands on Activity
• Conversation Techniques: Hands on Activity
• Adult Learning and Development Techniques
• Techniques That Enhance Learning: Hands on Activity
• Trainer Tips and Checklists: Tool Review

Day 2: 8:30 a.m. – 5:00 p.m.

• Review of Building Blocks from Day One
• Root Cause Analysis and Corrective/Preventive Action Planning (CAPA)
• RCA Exercise- Team Exercise
• Recruitment and Retention
• Enrollment Potential Evaluation- Discussion
• Recruitment Action Plan Review and Discussion
• Monitoring Plans
• Development and Prioritizing- Discussion
• Project Management: Tools, Techniques and Practice
• Tool Review, Development Strategies and Discussion

• Hands on development of a recruitment action plan
• Prioritization activity for workload and activity balance 
• Conversation development and techniques practice and discussion

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.

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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE# 0778-0000-15-004-L01-P. Released: 3/15.

Hold this course at your company!

For more information, contact Naila Ganatra at (215) 413-2471.