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 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
- 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:
Marla Hoelle, R.N., B.S.N.,
C.C.R.A.-PM, P.M.P.
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.
Click here for complete trainer
biographies
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
- 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.
Click here for our seminar
cancellation policy
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.
The New Jersey State Nurses Association is accredited by the ANCC Commission on Accreditation of the American Nurses Association as an approver of continuing education for nursing. As an accredited body, NJSNA has approved this program for: Contact hours competed: 14.25 Approval Number: 7892-1/19-21
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.