Foreign Medical Graduate
25 Years in the medical Field
18 Years in clinical research working as a clinical research coordinator/ Business development/Project Manager/ Site Manger
Profound understanding of clinical research methodology and regulations
Excellent project management skills
Responsible for all procedures required for a study start-up: regulatory documents, pre-site visits.
Initiate study contacts within the industry
Responsible for initiation and communication with referring physicians
Handle the day to day operations at the office. Initiate patient recruitment, Co-manage scheduling for clinic and research study visits
Managed multiple patient recruitment projects in various stages of development/implementation.
Developed/implemented/managed patient recruitment strategies, tactics and materials for local advertising campaigns.
Responsible for resource procurement, budgets and planning key project reports and management of communications between clinical trial manager and vendors.
Managed project coordinators
Coordinated selection of investigators and negotiated contracts
Coordinated and facilitated clinical trial working group meetings discussing study activities, issues and milestones
Contracted and managed outsource vendors
Training on Protocol, CRF, Data Listings, Study Specific Processes/Procedures/Forms
Training on PSV, IV, IMV and COV
Responsible for central IRB submission
Responsibility for clinical study budget with budget oversight responsibility for
Coordinates clinical trials in several indications
Responsible for 4 independent sites in the Miami/ Hialeah area
Procuring studies for several independent sites
Monitor enrolling site performance for subject accession
Serve as a primary source for all regulatory aspects of the study
Monitored local clinical trials within facilities
Responsible for payments submission to facilities affiliated to me
Responsible for budget/Contract submission to Sponsor/Sites/ CRO
