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.
- Explain the most recent regulations and guidance documents that govern clinical research
- Discuss current issues that affect clinical monitoring
- Describe the 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
- Understand how to manage situations involving fraudulent data
- Discuss FDA’s BIMO program for sponsor and investigator inspections
- CRAs with management responsibilities that include mentoring and assessing monitoring skills and complex issues involving site management, study management, sponsor/ CRO challenges
The course will be led by one of the following instructors:
Nikki Christison, B.S., C.C.R.A.
Gary B. Freeman, M.S., C.C.R.A
Marla Hoelle, R.N., B.S.N., C.C.R.A., P.M.P.
Lily Romero, P.A., C.C.R.C.
Liz Wool, R.N., B.S.N. C.C.R.A., CMT
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Day 1: 8:30 a.m. – 5:00 p.m.
- Regulatory Update: The latest FDA regulations 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
- Managing Stakeholders: Developing and communicating realistic expectations; reaching stakeholder agreement
Day 2: 8:30 a.m. – 5:00 p.m.
- Site Management (Performance)
- Identifying, Reporting and Managing Study-Specific Issues/Corrective and Preventive Action
- 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
- Reviewing Reports and Study Documentation
- Case Studies/Scenarios: Assessing Monitoring Skills, Site Issues, Stakeholder Relations
- Detecting Fraudulent Data
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# 0778-0000-15-006-L01-P. Released: 1/15.
This continuing nursing education activity was approved by the New Jersey State Nurses Association, an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation.
Approval Number: 7448-12/13-15. 14 Contact Hours
Participants will receive 14 hours of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.