Responsible for safe and correct implementation of clinical trial protocols and ensuring that protocols are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
Telephonically contacts study patients / subjects and schedules study participants daily.
Enters all subject appointments on the site appointment calendar on a timely basis on the same day the appointment was scheduled.
Answering daily incoming telephone calls from individuals inquiring on enrolling studies. Identifies callers, participates in the pre-screening process of potential subjects to assess suitability and schedules appointment daily.
Maintains records and other documentation of training.
Works closely with Investigators.
Assists with study materials including but not limited too: Case report forms (CRFS), enrollment logs, and drug/device accountability logs.
Conducting laboratory procedures, performs specimen processing and shipment of biological specimen duties.
Obtains vital signs and EKGs and performs all other procedures and assessments required by each protocol.
Completes the Case Report Forms (CRF) of subject visit. All applicable sections of the CRF are accurately completed in their entirety. CRF’s are also signed and dated, as required.
Maintains Temperature logs, all logs according to protocol.
Performs safety and efficacy assessments per protocol.
Establishes and organizes study files, including but not limited to: study source documentation and other documents and records as required.
Works collaboratively with other members of the clinical research team and administrative support teams to ensure that protocol compliance and the timely and accurate documentation and submission of study data.
Maintenance of updated Crash Cart.
Medical Assistant
Coral Reef Medical Group
Miami, FL
03.2014 - 04.2018
Create requisitions for laboratory exams
Enter patient vital signs
Put injections
Phlebotomy
Ear irrigations
Call patients to schedule appointments
Wound care
Autoclave use
Electronic Medical records
Minor surgeries procedures
Assist in Pap-Smear procedures
Assist with medication refill requests
Handle incoming calls from Lab Corp and Quest Diagnostics
Assistant to Doctors in need
Administrative Assistant
Unlimited Property Management
Miami, FL
11.2011 - 01.2013
Accounts payable using QuickBooks for 504 residential units.
Solved any concerns or problems that tenants had
Placed work orders and followed up
Clerical duties included: Typing, filing, faxing and answering phones
Front Desk Supervisor
Continental Group Inc. at Asia
Miami, FL
03.2008 - 09.2011
Greeted residents, visitors and vendors
Oversaw all the front desk staff and their schedules
Provided training to all new hires on their assigned properties
Reviewed all daily logs, incident reports, package and guests log
Monitored emergency response system and responded to emergency situations in a timely and efficient manner
Sr. Staff Assistant
University of Miami HIV Clinic
Miami, FL
09.2006 - 12.2007
Assisted in the preparation of Medical charts
Checked for patient funding source and determined who can be seen by the PAVARNP
Clerical duties included: typing, filing, faxing, answering phone calls, sorting and delivering mail
Education
Medical Assistant Program - undefined
Fortis Institute
Miami, FL
05.2014
Associates - Communication
Universidad Sagrado Corazon
Puerto Rico
01.1989
Certification
Certificated Clinical Medical Assistant, Phlebotomist Certificated, Electrocardiograph Certificated, IATA Certified, ICH-GCP Certified, Medical Terminology Knowledge, Substantial experience using computerized information systems, Annual OSHA training, Occupational Safety & Health Administration (OSHA), HIV/AIDs Certification, Domestic Abuse Training Health Insurance Portability and Accountability Act (HIPPA), BLS/CPR Certification, Miami Dade Community College - Child Care Training (45 Hours required by DC) Seminar in ADHD by the Council of Private Schools of Puerto Rico (2000)
LANGUAGES
English
Spanish
Personal Information
Title: CCMA
CLINICAL TRIAL EXPERIENCE
Closely worked with Pharmaceutical companies and IRBs as clinical research coordinator and regulatory personnel with adult subject for multiple therapeutic indications and devices from Phase 1 thru 4. Some of these include Amgen, Bristol-Myer Squibb, Pfizer, Merck, Boehringer-Ingelheim, GlaxoSmith Kline, AstraZeneca, ect.