Gabriel Silver Email & Phone Number

Melbourne, Vic, Au

Melbourne, Victoria, Australia

Victoria, Australia

CPM experience specializing in early phase trials- Phase I FIH HV and Phase 2a.

Melbourne, Australia

Independent clinical trial management in accordance with local regulatory and applicable ICH-GCP guidelines. Including, but not limited to, management of protocol and related documents, resources, recruitment and retention, stakeholders, vendors, financials, data, and internal and external reporting.

Melbourne, Australia

Responsibilities:· Independent preparation and conduction of qualification, site initiation, routine monitoring and close-out visits· Ensuring trials are conducted as per local and global regulatory clinical research requirements (FDA, ICH and GCP), providing GCP training and guidance · Successful completion of numerous national study feasibilities· Consistent conduction of all clinical site activities according to the monitoring plan and in accordance with the study timelines and budget· Motivating and training investigators and site staff to ensure that all study obligations are met and in line with study timelines· Investigator Meeting presentation experience· Experience working on a broad range of therapeutic areas including oncology, cardiovascular, and addiction medicine· Creation of feasibility training presentation made available for global team training · Initiation and running of regular internal recruitment meetings, ensuring optimal site management, recruitment, and oversight· Successful Sponsor audit of 2 sites

Melbourne, Australia

Responsibilities:· Providing oversight, coordination, and training in feasibility, recruitment and site engagement efforts in the Asia Pacific Region, including Australia, New Zealand, Singapore, Malaysia, Philippines, Thailand, Vietnam, Taiwan, South Korea, Hong Kong, China, Sri Lanka, and India· Oversight of all pre and post award feasibility studies coming to APAC Region, ensuring complete and timely responses from cross matrix teams· Creation and development of country specific site and feasibility databases· Increasing Medpace brand visibility· Implementation of Medpace Flagship Site program in APAC Region, increasing Medpace-Site relationships· Liaison and contracting of recruitment vendors

Melbourne, Australia

3 years as Stroke Research Coordinator, 7 years as Senior Stroke Research CoordinatorResponsibilities:· Coordination of numerous Phase 1b-III academic and Sponsored clinical trials· Facilitation, management and co-ordination of start-up activities including study/site feasibility and selection, ethics and governance submissions, budget negotiations, and site initiation · Management of all ongoing trial related activities post start up, including patient recruitment, follow-up, assessment, EDC maintenance, and close-out· Thorough understanding of the local and global regulatory clinical research requirements (ICH and GCP), ensuring all trials conform to these standards· Preparation of financial and progress reports as required by study sponsors/Clinical Research Organizations· Co-ordination of project logistics and training associated with laboratory, radiology, emergency, medical records, and pharmacy requirements· Development and implementation of standard operating procedures as required· Creation and writing of position descriptions, advertisements and interview questions· Interviewing, selecting, training and mentoring of new coordinators· Running stroke research team meetings Initiatives and achievements:· Creation of new staff orientation pack resource, coordinator workload assessment tools, trial task templates, stroke research handbook resource· Management of on-call hours, saving $10,400 pa· Set RMH record- trials coordinated at one time-13 (2013)· Set Sponsor Record-Lead Site (plus 5 sites) Ethics Application Submission Time from Protocol receipt-13 days (2014)· Top national recruiter for numerous academic and Sponsored trials· Nil lost to follow up

Australia

Co-Chair with Prof Sandy Middleton. Leadership of 8 person executive. Provision of numerous education and networking opportunities on a national scale. 350 members. www.asnen.org

Australia

Assistance with the management of the affairs of the Society. Includes conducting an annual national scientific meeting (400+ pax), providing membership awards, providing input to guidelines on stroke care, contributing to the Australian Stroke Coalition, providing representation on federal and state committees which formulate government policy on stroke. 280 members.

Florey Neurosciences

Included EXTEND IV, EXTEND IA, PrePARE, TASTE, STOP-AUST, TIMES. Planning and management of national and international trials. Tasks include management of Protocols, recruitment, site selection and feasibility, Investigator Meetings, Sponsor liaison and negotiation. Spanning 32 sites and 3 countries

Australia

Facilitation of academic and sponsored stroke trials in Australasia, from feasibility to close out. Budget negotiation and template creation. Facilitation of educational and networking opportunities. Administrative management of the Network. Liaison between members, Committee, Sponsors, suppliers, Investigators.

Melbourne, Australia

Leadership of Executive Team. Professional Development, Annual Educational Dinners, Sponsorship and Member Grants introduced. Enterprise Bargaining Agreement negotiations between VMIA and ANMF, research nurses to be recognized for the first time, 87 members.

Parkville, Victoria

Master’S Degree, Health/Health Care Administration/Management

Bachelor’S Degree, Registered Nursing/Registered Nurse, Rn Division 1