New position with the Cardiovascular Research Department.

Site management of multi-clinical trial projects in accordance with GCP/ICH Guidelines and FDA Regulations. Conducted protocol visits of Site Feasibility, Site Initiation, Interim Monitoring, Close-out; Ensured study staff training/certifications; Performed subject study visits, collected assessments, collected/ processed/ shipped specimens; IATA Certified; Source document/CRF completion; EDC management; Query Resolution; Maintenance of Trial Master Files; Regulatory Documents; AE/SAE reporting.

Largest Central Florida infectious disease practice with specialized treatment of HIV/AIDS, viral Hepatitis, STDs, post-exposure prophylaxis, high resolution anoscopy clinic, clinical research and out-patient infusion clinic. Managed staff and clinic operations; Provided patient care coordination, case management. Educated patient on disease management, treatment adherence, risk reduction. Florida State Certified HIV pre/post testing counselor. Completion of FMLA, Short/Long-term disability, ADAP, housing/food assistance forms. Formulated appeal letters for denied medication and services. Managed practice employee health: Annual TB Screen/Vaccines/ CPR/OSHA recertification. Performed EKGs, phlebotomy, IV insertion - Lead role in emergencies. Back-up clinical research coordinator.

Subject screening/enrollment; Performed informed consent process; Source document/CRF completion; IP dispensation/accountability; Collected/processed/shipped specimens; IATA Certified; State of Florida Certified pre/post-test HIV counselor.

Site management; Regulatory & IRB Document Files; Staff training; Marketing/PI recruitment.

New SMO Initiative: Design of clinic; Facility set-up/supply; Project feasibility; Development of SOPs; Marketing/PI recruitment.

Cardiovascular clinical trials site manager; Appointed to Compliance Task Program; Supervisor for 12 medical assistants; Cardiac Stress Test Assistant.

Hospital inpatient and outpatient cardiovascular clinical trials; Screening/enrollment/ICF; Conducted all study specific activities; Collected/processed/shipped specimens; Data collection/submission/reporting.

Perioperative