Summary
Overview
Work History
Education
Certification
Research Experience
Data Reporting/Capturing
Computers
Timeline
Generic

Patricia Gonzalez

Redondo Beach,CA

Summary

Goal-driven bilingual healthcare professional offering over 19 years of refined clinical and administrative experience, well-versed in study protocols, standard operating procedures, and general trial oversight. Excellent problem-solving abilities with a detail-oriented nature. Efficient and highly adaptive working in fast paced settings with diverse patient populations, physicians and project directors. Authoritative clear communicator that provides operational excellence and organizational development with proven success in leadership that inspires team members to excel in a creative work environment.

Overview

15
15
years of professional experience
1
1
Certification

Work History

Lead Medical Assistant

Pacific Health & Wellness Agency
Redondo Beach, CA
05.2013 - Current
  • Provide clinical, administrative support and skills to Facey, PSJH Torrance, Providence City of Hope, Torrance Memorial, Encino-Tarzana, Hoag, Dignity Health, Axminster, Alta-Med, Healthcare Partners, Providence Medical Group
  • Professionally and courteously verify appointment times and go over any special instructions with patient prior to visit.
  • Train and mentor new and existing staff on new equipment, systems and/or processes to ensure smooth adaptation.
  • Maintain accurate records of patient care, condition, progress and concerns via EMR.
  • Obtain information about clients' medical history, complaints and allergies. Recorded in systems (Epic)
  • Perform clerical duties, such as word processing, data entry and answering phones.
  • Perform monthly inventory and maintain office and medical supply counts/PAR levels.
  • Monitor vital signs, such as blood pressure, temperature, pulse, EKG, pulse oximetry, body composition analysis, bone density, biometric screenings, venipuncture and injection administration.
  • Enforce department policies and procedures to keep team operating effectively and delivering top-notch care.
  • Maintain positive relationships with all clinics, facilities, support marketing and big developments.

Clinical Research Coordinator /Clinical Operations Associate

PinPoint Staffing
Downey, CA
02.2021 - 07.2021
  • Strategic planning with principle investigator, director, project manager, CRA, CRO, IRB, and data management team to create and implement protocol and source documents.
  • Collaborate with physician, management, and research team to promote and recruit for all studies. Responsible for recruitment for 6 out of 7 sites, increased recruitment by 200%.
  • Participated in site initiation visits and weekly investigator meetings, implementing trials in accordance with study timelines and budgets.
  • Created spreadsheets using Microsoft Excel for daily, weekly and monthly reporting to insure recruitment goals achieved.
  • Managed quality assurance program, including on-site evaluations, and internal audits.
  • Collaborated in continuous improvement by generating suggestions and engaging in problem-solving activities to support teamwork.
  • Worked with principal investigator and sponsors to facilitate daily trial activities while complying with research protocols.
  • Maintained compliance with regulatory documents and protocols covering patient care and clinical trial operations.
  • Schedule and attend study visits, complete assessments, device training, device calibration, and maintain electronic case report forms.
  • Report to IRB any findings and allegations of non-compliance.
  • Followed informed consent processes, collected data, maintained records, operations manuals and case report form requirements.

Certified Medical Assistant/Clinical Research Assistant

Ablon Skin Institute & Research Center
Manhattan Beach, CA
01.2018 - 02.2021
  • Lead Study Coordinator for 8 studies, back up for all other trials, with an average of 120 patients; supervise new hires and manage study pool.
  • Screen patient records, databases and physician referrals to identify prospective candidates for research studies.
  • Manage initiation visits and investigator meetings, implementing trials in accordance with study timelines, budgets, and protocols.
  • Complete internal sponsor audits, as a result of being the highest enroller, with no findings
  • Onboard new hires with no clinical research background and trained on IIT's, Phase II and III studies
  • Schedule and attend study visits, complete assessments, maintain source, photography, obtain vital signs, perform EKG's, venipunctures, gathered, processed and shipped lab specimens / 98% accuracy
  • Collaborate with research team and PI to promote and recruit for all studies.
  • Report to IRB any findings and allegations of non-compliance
  • Work with principal investigator, clinic director and sponsors to facilitate daily trial activities and comply with research protocols.
  • Managed quality assurance program, including on-site evaluations, internal audits and customer surveys.
  • Helped generate $2.0M in revenue via 100% study compliance and protocol adherence.
  • Strategic planning with principle investigator, director of clinic, project manager, CRA, CRO, IRB, clinical team leader, and data management team to implement the transition to virtual visits due to Covid-19. IRB approval Study Participant Memo regarding 'Modifications to Study Visits / Source, as a result of Covid 19', Re-consenting process, home photography protocols, and source data verification for accuracy.
  • Blinded / non blinded IP dispensation
  • Interview potential new hires

Buyer

Culinary Arts
Los Angeles, Ca
03.2014 - 01.2016
  • Described product to customers and accurately explained details and care of merchandise.
  • Negotiated pricing with vendors regarding wholesale billing and marketing procedures.
  • Composed outgoing correspondence and reports for managers with daily deadlines.
  • Performed accounts receivable duties including invoicing, researching, discrepancies and reconciliations.
  • Reviewed sales price and operating costs.
  • Complied annual recommendations for end of fiscal year budgets.
  • Ordered and maintain inventory of office/production supplies.
  • Oversaw daily office operations for staff of 100 employees.
  • Reduced overhead by taking on more responsibility with creative and administrative projects.
  • Trained and supported users during new system implementations and upgrades.
  • Ensured exceptional client service and quality product offerings.
  • Developed reputation as an efficient service provider with high levels of accuracy.

Medical Assistant

Pacific Heart Institute
Santa Monica, CA
03.2010 - 12.2011
  • Assisted with clinical research and trials on new pacemaker devices.
  • Performed procedures and operated special medical equipment as delegated by a licensed professional, including blood draws, IV insertion, EKGs, 24 hour holter monitors, Dobutamine/Exersice Echocardiograms, Thallium stress test, CT Scans and EECP.
  • Educated patients and families about pre- and post-operative care, wound care, preparation of healthy meals, independent living and adaptation to disability or illness.
  • Monitored vital signs, such as blood pressure, pulse oximetry, temperature and pulse.
  • Collected blood, tissue and other laboratory specimens and prepared them for lab testing.
  • Changed sterile dressings, suture and staple removal, while providing a comforting environment.
  • Maintained accurate records of patient care, condition, progress and concerns.
  • Performed clerical duties, such as word processing, data entry, answering phones and filing.
  • Took advantage of opportunities for continuing education, quality assurance and performance improvement activities.

Education

Certified Medical Assistant - Medical

Bryman College
Gardena, Ca
2003

Certification

  • Good Clinical Training 12-17-2020
  • NIH Protecting Human Research Participants 01-08-2020
  • Transporting Dangerous Goods Training 01-08-2020
  • Handling/Offering for transportation of dangerous goods training 01-08-2020
  • BLS
  • Privacy & HIPPA

Research Experience

A Prospective, Multicenter, Open-label single-arm feasibility study assessing the tolerability of opioid medication reduction in conjunction with noninvasive peripheral nerve stimulation (NPNS) for patients taking prescription opioids to treat moderate-severe primary RLS


A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection (DAXI for Injection) for the Combined Treatment of Upper Facial Lines (Glabellar Lines, Dynamic Forehead Lines and Lateral Canthal Lines)


A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficiency and Safety of DR220-67 Anti-Aging Serum in the Treatment of Facial Lines in Women Ages 35-60


A Prospective, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of a Combination of 3% Minocycline and 0.3% Adapalene Topical Foam Formulation for the Treatment of Moderate-to-Severe Acne


A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Ability and Safety of a Nutraceutical Supplement with Standardized Botanicals to Promote Hair Growth in Perimenopausal, Menopausal and Post-Menopausal Women with Self-Perceived Thinning Hair


A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa


A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S6G5T-3 in the Treatment of Acne Vulgaris


A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2-Arm, Parallel Group Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris


A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Study to Evaluate the Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects


A Multicenter, Randomized, Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines


A Randomized, No-treatment Controlled, Evaluator-blinded, Multi-center Study to Evaluate the Effectiveness and Safety of Restylane Defyne in the Chin for Augmentation and Correction of Chin Retrusion


A Multicenter, Randomized, Double-Blind, Parallel Group, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 1% and 3% Topical MIinocycline Gel (HY01) in Patients With Papulopustular Rosacea


A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy and Safety Study of KX2-391 Ointment 1% in Adult Subjects With Actinic Keratosis on the Face or Scalp


An Open Label, Multi-Center Trial to Assess the Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines (SAKURA OPEN LABEL SAFETY)

Data Reporting/Capturing

Epic, Medidata (RAVE), eCaselink, AG Mednet, Covance, ERT, Inform, Oracle IRT, iMedNet, ICD-9

Computers

Microsoft Office, Outlook, Word, Excel, Powerpoint, 365, Windows: Vista, 7, 8, 10, Adobe acrobat

Timeline

Clinical Research Coordinator /Clinical Operations Associate

PinPoint Staffing
02.2021 - 07.2021

Certified Medical Assistant/Clinical Research Assistant

Ablon Skin Institute & Research Center
01.2018 - 02.2021

Buyer

Culinary Arts
03.2014 - 01.2016

Lead Medical Assistant

Pacific Health & Wellness Agency
05.2013 - Current

Medical Assistant

Pacific Heart Institute
03.2010 - 12.2011

Certified Medical Assistant - Medical

Bryman College
Patricia Gonzalez