Barnett International's Core Curriculum courses are comprehensive role-based training programs designed to provide participants with hands-on, in-person training. Held four times a year during Barnett’s “Clinical Research Training Weeks,” courses take place at state-of-the-art corporate meeting centers or in centrally located hotels on the East and West Coasts of the U.S., and offer focused, performance-based training and employee development.
Monitoring Clinical Drug Studies: Advanced
This course offering will take place live via WebEx from 9:00 AM – 4:00 PM Eastern each day. Participants will receive an email confirmation that includes the seminar link to enter the meeting room as well as the audio connection information.
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
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
The course will be led by one of the following instructors:
Marla Hoelle, R.N., B.S.N., C.C.R.A., ACRP-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.
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)
- 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
- 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.
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#: 0778-0000-21-030-L04-P. Released: 3/21.
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.