Académique Documents
Professionnel Documents
Culture Documents
Core Competencies
Clinical Research Studies / Clinical Trials * Informed Consent * Good Clinical P
ractices (GCP)
Participant Screening * Data Management * Study Requirements * Standard Operatin
g Procedures
Instructional Design * Classroom Instruction * Presentations / Public Speaking *
Staff Supervision
Healthcare Regulations - FDA, TPD, EMEA, ICH, MHRA * Staff Training / Procedure
Demonstration
PROFESSIONAL EXPERIENCE
CETERO RESEARCH, Miami Gardens, Florida * 2007-Present
Clinical research organization (CRO) offering phase I-IV clinical pharmacology t
rials.
Clinical Study Manager / Screening Coordinator / Bilingual Medical Screening Spe
cialist
Orchestrate all processes, procedures, and internal / external personnel involve
d in clinical trials for such medical specialties as cardiovascular, dermatology
, and immunology, among others. Direct internal teams and Contract Clinical Staf
f through each stage of the trial. Prepare documentation, including Informed Con
sent Forms, ICH reports, and Case Report Forms (CRF). Allocate Clinical Trial Ma
terial according to study specifications and standard operating procedures (SOP)
. Recommend enhancements to SOPs based on regulations, GCP, and audit results. S
erve as liaison to the Principal Investigator (PI), sub-investigators, and the I
nstitutional Review Board.
Key Highlights:
* Managed clinical research efforts and ongoing client relations with Schering-P
lough, Sanofi-Aventis, Noven, TEVA, Merck, Tris Pharma, Abbot, Mylan, and Solvay
.
* Provided hands-on instruction and demonstrations of various procedures, includ
ing phlebotomy, medical history collection, IV line and pump preparation, and do
se dispensing.
* Secured highly qualified participants through proactive collaboration with Sub
ject Recruitment.
* Executed bilingual participant screening for eligibility in Spanish and Englis
h.