Professional Experience

Clinical Research Coordinator

New Horizon Research Center September 2018 - Present Title Clerk

Manheim Ft. Lauderdale Auto Auction 2016 - 2018

• Attention to Detail

• Quality of Work

• Communication

• Collaboration

• Computer Pro ciency

• Problem-Solving

• Strong Work Ethic

• Fluent in English and Spanish

• Strong Organizational and Time

Management Skills

• Coordinating clinical trials conducted by a supervising Principal Investigator in accordance with FDA, GCP and protocol guidelines.

• Reviewing subject comprehensive medical documentation to determine protocol eligibility under the supervision of the Principal Investigator.

• Providing operational and administrative support in the management of patients accrued to multiple research protocols to assure subjects' safety and regulatory compliance.

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

• Ensuring study protocol adherence, including completion of protocol speci c procedures and the completion of protocol speci c documents while obtaining relevant medical information from patient clinic charts /medical records.

• Ensuring that all biological samples; blood and urine specimens, tissue samples, pharmacokinetics samples, etc. collected and processed as per protocol.

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

• Ensuring data integrity and consistency in computer database and written records by entering and reviewing subject data for accuracy.

• Ensuring that randomization and registration of patients are performed in compliance with the study protocol, ICH-GCP, and federal regulations.

• Ensuring timely IRB submissions of initial protocol, continuing reports, amendments, safety reports, AEs, SAEs, UP, deviations, etc.

• Participating in a collaborative, empowered work environment as demonstrated through teamwork and ensuring work environment is organized and functions ef ciently.

• Establishing and maintaining contact with study subjects, CRAs, and study sponsors.

• Responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, SOPs and all applicable regulations and guidelines and ensuring effective data ow associated with research protocols.

• Providing direct communications link to customers to ensure their expectations are met and service issues are resolved.

• Investigates, troubleshoots, and resolves customer problems and issues.

• Receiving payments for purchased automobiles.

• Maintaining contact with dealers, sales department, and service department to resolve any outstanding issues or concerns from customers.

• Processing title requests, and distribution of titles to customers.

• Accounts Receivable, and processing payments from vehicles purchased and sold. Michael

Hernandez

Certi ed Clinical Research

Coordinator

Miramar, Florida. 33027

ad0b5c@r.postjobfree.com

954-***-****

Highly motivated individual

experienced with managing

and conducting clinical

research studies in compliance

with ICH-GCP guidelines, Site

and Sponsor SOPs, Local Laws

& Regulations, Protocol and

associated documents.

Key Skills

Education

Associates of Arts in Business Administration

Broward College at 3501 Davie Rd. Davie, FL 33314 2016 - 2018 Certifications

Certi ed Clinical Research Coordinator • ACRP

2021

Phlebotomy Certification • State of Florida

2018

IATA: International Air Transport Association • Mayo Clinic 2021

GCP: Good Clinical Practice • CITI Program

2021

Recognitions

• Witnessing a lack of patient diversity at my site, I launched an initiative to increase the participation of subjects from communities that are under represented in clinical research. Through intentional subject recruitment efforts such as community outreach, lunch & learns, and focused recruitment initiatives, my site saw a five-fold increase in participation from subjects from these communities due to my efforts.

• Attention to Detail

• Quality of Work

• Communication

• Collaboration

• Computer Pro ciency

• Problem-Solving

• Strong Work Ethic

• Fluent in English and Spanish

• Strong Organizational and Time

Management Skills

Michael

Hernandez

Certi ed Clinical

Research Coordinator

Miramar, Florida, 33027

ad0b5c@r.postjobfree.com

954-***-****

Highly motivated individual

experienced with managing

and conducting clinical

research studies in compliance

with ICH-GCP guidelines, Site

and Sponsor SOPs, Local Laws

& Regulations, Protocol and

associated documents.

Key Skills

• Provides administrative support to ensure ef cient operation of of ce.

• Answers phone calls, schedules meetings and supports visitors.

• Carries out administrative duties such as ling, typing, copying, binding, scanning etc.

• Maintains supplies inventory by checking stock to determine inventory level, anticipating needed supplies, placing and expediting orders for supplies. Administrative Assistant

Gastroenterology Associates 2015 - 2016

Association of Clinical Research Professionals

through its independent affiliate, the Academy of

Clinical Research Professionals, bestows upon

Michael Hernandez

THE DESIGNATION OF

Certified Clinical Research Coordinator

for having satisfied the standards of ethical and responsible clinical research, including substantial professional experience performing role- specific essential duties, demonstrating proficiency through a comprehensive examination, and committing to ongoing professional development in the practice of clinical research.

Steven Ziemba, MBA, PhD, FACHE, FACRP, CCRC,

ACRP-PM

Chair, Academy of Clinical Research Professionals

This program meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

Apr 26, 2021

May 31, 2025

CERTIFICATION DATE:

EXPIRATION DATE:

Contact this candidate