Clinical Trial Management Resources and Professional Development
Discover professional development opportunities for clinical research professionals and resources for managing clinical trials effectively. Learn about training programs, networking platforms, financial management, and personnel resources to enhance your clinical trial management skills.
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PROFESSIONAL DEVELOPMENT AND RESOURCES FOR CLINICAL TRIAL MANAGEMENT Britte Beaudette-Zlatanova, Ph.D. Clinical Research and Operations Manager General Clinical Research Unit
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/
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/
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/
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
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!
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
