Course Description

This course will focus on more complex and challenging issues affecting the Clinical Research Associate with management/leadership responsibilities. Current hot topics and trends will be discussed. Participants will analyze case studies to identify how monitors/study leaders could have identified, managed, and followed up on under performance or non-compliance issues. Corrective and preventive action plans (CAPA) will be developed as part of the course activities. Training and mentoring techniques will be included to assist training/mentoring sponsor/CRO and site staff.

Learning Objectives

• Explain the most recent regulations and guidance documents that govern clinical research
• Discuss current issues that affect clinical monitoring
• Describe effective mentoring techniques
• Discuss ways of assessing monitor skills
• Develop techniques to manage stakeholders
• Define techniques to promote successful site management
• Identify, manage, and report study-related issues
• Describe how to manage situations involving fraudulent data
• Discuss FDA’s BIMO program for sponsor and investigator inspections

Who Should Attend

• CRAs with management responsibilities that include mentoring and assessing monitoring skills and complex issues involving site management, study management, sponsor/ CRO challenges

Instructor

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

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.

Lily Romero, P.A., C.C.R.C.

Elizabeth Weeks-Rowe, LVN, C.C.R.A.

Click here for complete trainer biographies

Course Outline

Day One

• Regulatory Update: The latest FDA Guidances will be reviewed
• Monitoring Visits Update: Risk-Based Monitoring Approach
• Monitoring Plans: Writing, evaluating, implementing, and assessing effectiveness
• Mentoring, Communication, and Negotiating Skills: Tips for making the most of “mentoring” opportunities
• Co-Monitoring/Assessing Monitoring Skills: Techniques for assessing monitors in the Sponsor/CRO environment

Day Two 

• Managing Stakeholders: Developing and communicating realistic expectations; reaching stakeholder agreement
• Site Management (Performance)  
• Identifying, Reporting and Managing Study-Specific Issues/Corrective and Preventive Action Plans
• Managing Situations Involving Fraudulent Data
• Regulatory Compliance: Discussion of sponsor and investigational site inspections by FDA; current information regarding FDA and regulatory authority inspections/audits; practical tips for preparing your site for an audit

Interactive Activities

• Reviewing Reports and Study Documentation
• Case Studies/Scenarios: Assessing Monitoring Skills, Site Issues, Stakeholder Relations
• Detecting Fraudulent Data

Registration Fees

Accreditation Information

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#: 0778-0000-24-006-L99-P. Released: 3/24. 

                Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.