Fairplay Consultants, Inc. - Advanced Training for CRAs and CRCs

Advanced Training for CRAs and CRCs

Description:

Case studies, work groups, interactive sessions, and computer-lab EDC experiences.

Course Level:

Advanced

Overview:

This one week session provides stimulating learning experiences to senior-level, experienced monitors, and research personnel at study sites. Through lecture and interactive workshops, role-playing, and case study scenarios, the participants will apply their past knowledge and newly learned information to on-the-job realistic scenarios.

Who Should Attend:

Senior level personnel conducting clinical trials at the Sponsor location, the study site, or industry vendor provider location.

Objectives:

Demonstrate the ability to apply past knowledge and newly learned information to real-life clinical trial applications.

Identify metrics,training, retention tactics for clinical research coordinators and study support staff

Discuss communication skills - handling difficult people and impossible situations effectively

Describe data management, query resolution, and the differences between paper-based trials and electronic data capture (EDC) trials

Show ability to use budgeting tools and manage clinical trial projects and investigative site financials

Explain the process of negotiating budgets and contracts at the sponsor and site level

Map out a process of expanding site operations and infrastructure

Clarify methods for filling site pipelines with more trials & research grants

Demonstrate the ability to create a SOP for Adverse Event Reporting

Explain the necessity for SOPs, training, and written documentation

Discuss the historical aspects, current trends, and regulatory aspects related to human safety protection

Explain the preparation, conduct, and follow-up to an FDA audit

Agenda:

Morning session: Lecture Afternoon session: real-life clinical trial applications Evening session: Case Study/Group Discussion

Course materials: Lessons from a Horse Named Jim textbook Lessons from a Horse Named Jim CD-Rom and exam

Please note:

If you would like to see this course offered in your area, please contact us for scheduling opportunities and fees.

For further training in this subject area, please consider:

Human Research Protection Workshop

Notes:

Consider joining an on-line session for The Least of My Brothers ethics course to participate in an in-depth review of research ethics and clinical trial professional's responsibilities