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:

Gary B. Freeman, M.S.

Marla Hoelle, R.N., B.S.N., C.C.R.A.-PM, P.M.P.

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

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Course Outline

Day One: 8:30 a.m. – 5:00 p.m.

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: 8:30 a.m. – 5:00 p.m.

Managing Stakeholders: Developing and communicating realistic expectations; reaching stakeholder agreement
Site Management (Performance) Regular Copy
Identifying, Reporting and Managing Study-Specific Issues/Corrective and Preventive Action Plans Regular Copy
Managing Situations Involving Fraudulent Data Regular Copy
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

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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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#: 0778-0000-18-007-L01-P. Released: 1/18.

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