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
- Describe effective mentoring
- Discuss ways of assessing monitor
- Develop techniques to manage
- Define techniques to promote
successful site management
- Identify, manage, and report
- Describe 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
B. Freeman, M.S.
Marla Hoelle, R.N., B.S.N.,
Lily Romero, P.A., C.C.R.C.
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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
- 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
Two: 8:30 a.m. – 5:00 p.m.
- Managing Stakeholders: Developing and communicating realistic expectations; reaching
- 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
- Reviewing Reports and Study Documentation
- Case Studies/Scenarios: Assessing
Monitoring Skills, Site Issues, Stakeholder Relations
- Detecting Fraudulent Data
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#: 0778-0000-18-007-L01-P.
this course at your company! For more information, contact Naila Ganatra at +1