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

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) http://www.bumc.bu.edu/crro/training-education/clinical-research-seminar/ 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,

Professional Development Training, Newsletters, Networking Clinical Research Times http://www.bu.edu/crtimes/ Research Professionals Network http://www.bumc.bu.edu/crro/research-professional-network/ Association of Clinical Research Professionals (ACRP) and Society of Clinical Research Associates (SOCRA) https://www.acrpnet.org/ https://www.socra.org/ 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

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 https://www.bu.edu/ctsi/support-for-research/recruitment-retention/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!

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?

Clinical Trials Management Resources for Managing Logistics of getting study done General Clinical Research Unit http://www.bu.edu/ctsi/support-for-research/protocol-implementation/ Investigational Pharmacy Services http://www.bumc.bu.edu/crro/files/2017/05/IPS-Overview-2017.pdf BMC Laboratory Medicine Susan.mallard-shea@bmc.org, Office Manager BMC Radiology Mlavoye@bu.edu, Margaret Lavoye, Research Administrative Director

Clinical Trials Management Resources for Managing Logistics of getting study done Data entry systems http://www.bu.edu/ctsi/tools/ Recruitment www.bu.edu/ctsi/support-for-research/recruitment-retention/

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

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