resources for clinical trial management Britte BeaudetteZlatanova PhD Clinical Research and Operations Manager General Clinical Research Unit Professional Development Who is a clinical research professional ID: 1043831
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1. Professional development and resources for clinical trial managementBritte Beaudette-Zlatanova, Ph.D.Clinical Research and Operations ManagerGeneral Clinical Research Unit
2. Professional DevelopmentWho 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 interestedThings change all the time, how can we stay current?Training, Newsletters, NetworkingClinical Translational Science Institute (CTSI) and Clinical Research Resources Office (CRRO)http://www.bumc.bu.edu/crro/training-education/clinical-research-seminar/
3. Professional DevelopmentTraining, Newsletters, NetworkingClinical Research Timeshttp://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/
4. Clinical Trials ManagementWhat do you need to manage?PersonnelBudget / FinancesLogistics of getting study doneResources for Managing PersonnelHuman ResourcesID office, Occupational Health, Institutional Biosafety Committee, Institutional Review BoardIT Research Job Connectionhttps://www.bu.edu/ctsi/support-for-research/recruitment-retention/research-job-connection/
5. Clinical Trials ManagementResources for Managing Budget / FinancesBMC Clinical Trials OfficeVELOS Clinical Trial Management System?BU Post Award Financial Operations and Dept Grant ManagersHow can we track and be notified of payments?Start with a smart Clinical Trial AgreementSet up most payments to be automatic upon the enrollment of x subjects or completion of electronic data entry for a subject visitInvoice even though payment should be automatic—REQUIRE that invoice numbers be referenced on paymentsDept grant manager should be notified of all outgoing invoices and all received payments through PAFO or BMC CTOMeet with your study personnel regularly to find out what billable items have occurred
6. Clinical Trials ManagementResources for Managing Logistics of getting study doneGeneral Clinical Research Unithttp://www.bu.edu/ctsi/support-for-research/protocol-implementation/Investigational Pharmacy Services http://www.bumc.bu.edu/crro/files/2017/05/IPS-Overview-2017.pdfBMC Laboratory Medicine Susan.mallard-shea@bmc.org, Office ManagerBMC RadiologyMlavoye@bu.edu, Margaret Lavoye, Research Administrative Director
7. Clinical Trials ManagementResources for Managing Logistics of getting study doneData entry systems http://www.bu.edu/ctsi/tools/Recruitment www.bu.edu/ctsi/support-for-research/recruitment-retention/
8. How do you manage risk and optimize revenue?Spread the risk by having multiple clinical trialsBalance low enrolling studies of scientific interest with high enrolling studies or studies that pay large sums per patientThere is efficiency in scaleReduces chance you will need to lay off staffEmploy students wisely!
9. Moving forward……..Professional development and training must be supportedClinical Research Professionals should work together to improve work flowNeed job titles and responsibilities that are consistent across departments