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Clinical Research Trials

Location:
Miami, FL
Posted:
October 05, 2023

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Resume:

MARIA TERESA FERRER GUERRA

CURRICULUM VITAE

Mailing Address: 7701 Camino Real Apt A218, Miami, FL 33143

Phone number: +1-786-***-****

Email: adz6lo@r.postjobfree.com adz6lo@r.postjobfree.com

Maria T. Ferrer Guerra

Digitally signed by Maria T. Ferrer Guerra

Date: 2022.11.15

13:42:53 -05'00'

I am currently Clinical Research Coordinator for University of Miami (Fox Cancer Research Center) with 2 years of experience in research, and more than 20 years on the Health Industry.

I have worked for Alliance for Multispecialty Research (South Florida Research), conducting Phase I, II, III and IV Clinical trials.

Foreign Physician (Medical Doctor) graduated from Cuba in 2003, and with years of experience in the Health Industry. Foreign Certified General Practitioner, Family Medicine Specialist, and Ophthalmologist.

Excellent communication skills and proven patients satisfaction record. Team player with diligent work habits: strong initiative, goal oriented, organized and focused attention to detail. Bilingual (English and Spanish).

WORK EXPERIENCE:

Clinical Research Coordinator (CRC)

UNIVERSITY OF MIAMI FOX CANCER RESEARCH CENTER

November 2022 to Present

Assists the Monitors and PIs in the organization and preparation of Site Initiation Visits (SIV) and in providing the patients and their families with a thorough description of the research protocol.

Attends site disease group tumor board meetings and site disease group collaborative meetings.

Assures that all protocol revisions, informed consents, continuing reviews, serious adverse events are submitted to the appropriate IRB of record in a timely manner.

Compiles patient data and presents those to the PI for their determination of patient eligibility for protocol enrollment. Ensures eligibility forms are completed as required.

Assists PI in obtaining informed consent and documents the informed consent process as required. Enters required protocol enrollment report to CRIS Office and JHS CTO according to established procedures. Complete sand submits to the CRIS Office and/or JHS CTO Office protocol specific forms as required per UM and/or JHS policies.

Ensures study protocol adherence, including completion of protocol specific procedures and the completion of protocol specific documents while obtaining relevant medical information from patient clinic charts/medical records.

Establishes and maintains contact with patients/participants, health care providers, community agencies, study sponsors. Updates appropriate agencies such as sponsors, IRB, etc. regarding current status of research projects as required and under the supervision of the PI.

Maintains /logs progress reports to track both currently enrolled as well as follow-up participants.

Provides protocol specific study documentation required in the management of study patients as per the protocol, federal regulations, sponsor requirements, SOPs and UM policies while maintaining logs to track progress reports to both currently enrolled as well as follow-up participants.

Enters data onto case report forms and/or into computer database. Completes corrections/queries required at audits/monitor visits in a timely manner. Ensures data integrity and consistency in computer database and written records by reviewing entered data for accuracy.

Execute the plan developed for collection of protocol specific subject specimens, i.e. pharmacokinetics samples, blood specimen, tissue samples, etc. as per protocol.

Ensures that protocol lab kits and study specific supplies are obtained/ordered as necessary.

Responsible for the entry of and maintenance of the patient calendars. Ensures protocol specific data is entered into Velos.

Records and reports AEs, SAEs and UPs in compliance with federal regulations, the protocol and UM policies to the sponsor and/or IRB as directed by the PI.

Maintains logs including but not limited to the following: screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs and actively participates in monitoring visits and site audits.

Ensures that randomization and registration of patients are performed in compliance with CRS and UM policies, the protocol, ICH-GCP, and federal regulations.

Updates SCCC Business Office staff as requested about patient accruals/completed cycles for billing of Industry Studies and for calculation of RVUs for in-house studies and provides support with study related procedures as required, i.e., EKG, laboratory and tumor assessment studies.

Ensures timely IRB submissions of initial protocol, continuing reports, amendments, IND safety reports, AEs, SAEs, UP, deviations, etc. with support from the Sr. Regulatory Specialist.

Communicates all IRB and Sponsor related approvals, changes, information, etc. to the PI and study team and adapts to physician schedules to perform protocol specific patient visits and/or procedures including, but not limited to early AM and /or early evening hours as required.

Participates in a collaborative, empowered work environment as demonstrated through teamwork and ensures work environment is organized and functions efficiently.

Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center and provides coverage for other CRS SDGs as needed. Other duties as assigned.

ALLIANCE FOR MULTISPECIALTY RESEARCH (AMR - Miami, FL)

September 2021 to November 2022

Clinically manages an average of six clinical trials.

•Conduct Pre-screen and Screen subjects for eligibility using protocol specific inclusion and exclusion

Criteria, and updated site data base for future clinical trials.

•Followed Informed consent process by agencies regulation, maintains documentation, and provide copy of the signed informed consent to the subject.

•Schedule subject research visits and complete procedures consistent with protocol (i.e., Vitals sings, Phlebotomy, specimen process and shipping, 12-Lead ECG, etc.)

•Collect study data, create, and complete source documents. Ensure integrity of electronic data CRFs, and address queries.

•Communicate with PI, Sub-I to ensure that all laboratory results are reviewed for clinical significance and follow up on file reports in source subject binder.

•Communication with studies vendor and resolve any devise technical issues.

•Receive, maintain, and dispense study product in accounting log following protocol requirements.

•Ensure that AE and SAEs are properly documented and reported to PI, Sponsor and where appropriate.

•Schedule site monitor visits and set up for monitoring visit prior to monitors arrival.

•Maintain good communication with PI, Sub-I, monitors, and sponsor.

•Prepare or get involved in quality assurance audits performed by sponsors and regulatory authorities.

•Arrange space for study equipment and other trial material as deemed necessary.

•Keep track of study assessment to make sure compliance with protocol, ensure that protocols deviation is properly documented and reported to PI, Sponsor, and IRB.

•Take part in Investigator meeting, department meeting, and seminar to update knowledge of clinical research and related issues.

Ophthalmic Technician and Surgical Assistant

CENTER FOR EXCELLENCE IN EYE CARE BAPTIST HOSPITAL

January 2018 to September 2021

•Preparing patients and assisting the physician for examinations

•Explaining medical procedures to patients and calling in prescriptions to pharmacies

•Communication and customer service skills

•Insurance coding and medical terminology

•Assisting Dr. to do minor surgery procedures, and laser surgeries.

•Crosslinking surgery

Medical Assistant and Surgical Assistant

PRIMECARE CORAL GABLES

June 2015 to May 2018

•Preparing patients and assisting the physician for examinations and surgical procedures.

•Drawing blood (phlebotomy), removing sutures, and taking x rays and electrocardiograms.

•Explaining medical procedures to patients and calling in prescriptions to pharmacies.

Referral Coordinator

MIAMI BEACH MEDICAL GROUP - Miami, FL

December 2014 to May 2015

•Communication and customer service skills

•Insurance coding and medical terminology.

•Multi-line phone proficiency.

Physician Resident of Ophthalmology

ICO RAMON PANDO FERRER - HABANA, CUBA

January 2007 to August 2014

•Comprehensive eye exam, skiascopic refractions, lensometry, keratometry, intraocular pressure, corneal topography and pachymetry, specular microscopy, gonioscopy etc.

•Main surgeon in many surgical procedures of Glaucoma, Cataract ad combined techniques. First surgical Assistant in others surgical procedures such as: Oculoplastic, Cornea, Retina, Strabismus in adults and Childs etc.

•Ophthalmology Specialist duties with fellowships in clinical and surgical management of Cataract and Glaucoma.

General Practitioner, Physician Resident of Integral General Medicine (Family medicine)

POLICLINICO DOCENTE UNIVERSITARIO JULIO A. MELLA - Cuba, CA

September 2003 to December 2006

•Taking patient histories, performing or requesting diagnostic tests.

•Making diagnoses, prescribing treatment, administering vaccinations in patients with a wide range of conditions and performing follow-up examinations.

•Educating patients in disease prevention and health maintenance.

•Preparing medical records and clinical reports.

EDUCATION

1.Bachelor's degree

2.Registered Surgical Assistant American Board of Surgical Assistant (ABSA) - Miami, FL 2017 to June 2022 (License Expired)

3.Medical Assistant September 2014 to September 2018 (License Expired)

4.Ophthalmology Specialist Superior Institute of Medical Sciences of Havana - La Havana, Cuba 2009

5.Doctor of Medicine (MD), Superior Institute of Medical Sciences Of Camaguey, Cuba.2003

SKILLS

•Phlebotomy

•Communication skills, Bilingual

•Microsoft PowerPoint, Microsoft Word, Excel

•Hospital experience

•Medical terminology

•Customer service

•Ophthalmology

•Medical imaging

•Microscopy

•Medical records

•EKG

•Surgery

Maria T.

Digitally signed by Maria T. Ferrer Guerra

Date: 2022.11.15

13:43:41 -05'00'

Ferrer Guerra



Contact this candidate