1. Professional development and resources for clinical trial management
Britte Beaudette-Zlatanova, Ph.D.
Clinical Research and Operations Manager
General Clinical Research Unit
Introduce my background—basic researcher, clinical researcher, and then CRC with patient contact—no experience so took Clinical Investigations courses, joined CRP groups, relied on guidance from experienced CRCs, project management

2. Professional Development
Who is a clinical research professional?
A person who conducts some aspect of their work according to good clinical practice (GCP)
Why is professional development important?
Keeps us compliant, keeps us interested
Things change all the time, how can we stay current?
Training, Newsletters, Networking
Clinical Translational Science Institute (CTSI) and Clinical Research Resources Office (CRRO)
Examples of CRPs: Physician PI, nurse, coordinator, data manager, billing analyst
We want to be compliant with federal regulations but we also want to retain top talent
CTSI sends out newsletters with training opportunities,

3. Professional Development
Training, Newsletters, Networking
Clinical Research Times
Research Professionals Network
Association of Clinical Research Professionals (ACRP) and Society of Clinical Research Associates (SOCRA)
RPN goal is to improve the quality of research on campus by making a network, establishing best practices, mentoring
ACRP provide certifications that you have certain competencies, Rachelle will speak about additional training for admins at end

4. Clinical Trials Management
What do you need to manage?
Personnel
Budget / Finances
Logistics of getting study done
Resources for Managing Personnel
Human Resources
ID office, Occupational Health, Institutional Biosafety Committee, Institutional Review Board IT
Research Job Connection
How do you get personnel with BU badges access to BMC space? How do you get health clearance from Occ Health? Need to complete financial disclosures and get staff trained before adding personnel to IRB protocol, need to put personnel working with human blood on IBC protocol
Prob of chicken and egg: How can you hire staff to do start-up work before study starts? RJC!

5. Clinical Trials Management
Resources for Managing Budget / Finances
BMC Clinical Trials Office
VELOS Clinical Trial Management System?
BU Post Award Financial Operations and Dept Grant Managers
How can we track and be notified of payments?
Start with a smart Clinical Trial Agreement
Set up most payments to be automatic upon the enrollment of x subjects or completion of electronic data entry for a subject visit
Invoice even though payment should be automatic—REQUIRE that invoice numbers be referenced on payments
Dept grant manager should be notified of all outgoing invoices and all received payments through PAFO or BMC CTO
Meet with your study personnel regularly to find out what billable items have occurred
VELOS not fully operational –expand capability in the future?

6. Clinical Trials Management
Resources for Managing Logistics of getting study done
General Clinical Research Unit
Investigational Pharmacy Services
BMC Laboratory Medicine
Office Manager
BMC Radiology
Margaret Lavoye, Research Administrative Director

7. Clinical Trials Management
Resources for Managing Logistics of getting study done
Data entry systems
Recruitment

8. How do you manage risk and optimize revenue?
Spread the risk by having multiple clinical trials
Balance low enrolling studies of scientific interest with high enrolling studies or studies that pay large sums per patient
There is efficiency in scale
Reduces chance you will need to lay off staff
Employ students wisely!
If something is of high scientific value but it doesn’t pay well, you’ll have to make that money elsewhere
If you have LOTS of studies, it may make sense to specialize—have one person do regulatory while another sees and schedules participants
. Have lots of grad students who are eager to get patient contact experience, inexpensive and they are temporary –can be used for data entry or recruitment BUT don’t delegate them to tasks they don’t have experience and training to handle

9. Moving forward……..
Professional development and training must be supported
Clinical Research Professionals should work together to improve work flow
Need job titles and responsibilities that are consistent across departments
Can’t have supervisors that won’t dedicate time for their employees to get trained, there should be SOPs (CRRO has been working on)
IT, Billing, Coordinators, HR must all work together—don’t have defined job titles and competencies