Medical Assistant Quality Assurance

Maria S. Gonzalez, RMA, CCRC.

*** ** *** ******

Pembroke Pines, Fl 33029

Phone 954-***-****

Email: ********@*******.***

Objective:

To find a challenging CCRC position that will take advantage of my extensive experience as a ACRP Certified Clinical Research Coordinator with over 12 years of experience.

Qualifications and Skills:

• 12 years of experience as Clinical Research Coordinator

• ACRP Certified since 2008

• Able to work independently with minimal supervision

• Excellent time management skills

• Highly organized and detail oriented

• Able to work effectively and efficiently on multiple projects

• Thorough understanding of, FDA, GRP/GCP, and IRB regulations

• Proficient in Microsoft Word, Excel and PowerPoint

• Sound knowledge of medical terminology and clinical monitoring process

• In depth therapeutic and protocol knowledge as provided in company training

• Review and track essential study documents, which include Regulatory Files, Informed Consents, Safety assessments (AEs/SAEs) and Protocol Violation documents.

• Oversee trial progress by reviewing participant eligibility documentation, reviewing drug accountability records, verifying source documents (including source to eCRF) and managing data queries in the Electronic Data Capturing system (InForm).

• Supervise study staff in core research principles such as Quality Assurance procedures, study documentation procedures, GCP/GRP guidelines and IRB policy and procedures.

• Generate QA tools (QA plan, Report Templates and Participant Tracking Tools) to assist in the monitoring of protocols.

• Attend and participate in Investigator Meetings.

Education:

1990 Job for Progress Technical School

Nursing Assistant

Miami, FL

2000 American Registry of Medical Assistants

Registered Medical Assistant

Westfield, MA

Professional Experience:

2006-Present Certified Clinical Research Coordinator

Broward Research Group

Pembroke Pines, FL

Responsible for having in depth knowledge of protocol requirements for phases II, III, IV and good clinical practices as set forth by federal regulations. Act as liaison between the investigators, primary care providers, the Institutional Review Board (IRB), and the sponsor. Along with the investigator; screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while subjects are on study. Responsible for all data and source documentation, QA of all studies in charge of, adverse experience reporting, and maintenance of regulatory files. Also over 12 years of experience in therapeutic areas as, Pain Management, Arthritis, Obesity, Neurological Disorders, Woman Health, Gastrointestinal ect.

2004-2006 Clinical Research Coordinator

Miami Research Associates

Miami, FL

2003-2004 Medical Assistant

The Coupeville Clinic

Coupeville, WA

1998-2003 Research Assistant

Miami Research Associates

Miami, FL

1988-1998 Medical Assistant

Cardiology Associates

Aventura, FL

Research Experience:

Sanofi-Aventis, Alzheimer’s 2011

Merck Pharmaceuticals, Primary Insomnia 2011

AstraZeneca, OIC Constipation 2011

Novartis, Elderly Flu Vaccine 2010

Merck, Menstrual Migraines 2010

Novartis, Mayor Depression Disorder 2010

Medicus Research, Family Flu 2009

Eli-Lilly, Osteoarthritis Knee 2009

Sanofi-Pasteur, Flu 2009

Cephalon, Closed Traumatic Brain Injury 2009

Centocor, Crohns’s Disease 2009

Neurogen, Restless Legs Syndrome 2009

Sanofi-Aventis, Insomnia 2008

Arena, Insomnia 2008

Arena, Obesity 2008

Takeda, Insomnia 2007

TransOral, Insomnia 2007.

MediciNova, Insomnia 2007.

Takeda, Insomnia 2007.

Wyeth, Fibromyalgia, 2006.

Boerhringer Ingelheim, Hypoactive Sexual Desire Disorder, 2006.

Takeda, Primary Insomnia, 2006.

SimmsWT-2005, Obesity, 2005.

Arena, Obesity, 2005.

Amylin, Obesity, 2005.

PLX Pharma, Osteo Arthritis, 2005.

NFRAG Ltd, Obesity, 2004.

Cort-TV, Obesity, 2004.

CRL, Obesity, 2002.

Novartis, Obesity, 2002.

Merck, Colon Polyps, 2001.

Merck, Migraine, 2001.

Merck, Acid Reflex, 2000.

Sepracor, Primary Insomnia, 2000.

Merck, Flu Vaccine, 2000.

Proctor & Gamble, Heartburn, 1999.

Certifications:

Certified Clinical Research Coordinator #593101423

Nursing Assistant #593101423

Registered Medical Assistant #1337102

CPR & AED for the BLS for Healthcare Providers

Memberships:

American Registry of Medical Assistants

Association of Clinical Research Professionals

Languages: English & Spanish- Written and Spoken

References: Available upon request.

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