project Manager/ Site Director / Regulatory Specialists

Mayracezl Rodriguez

**** ***** ***. ***** **** CA 90620 / Tel. 626494920 / Email : adqugm@r.postjobfree.com

PROFESSIONAL SUMMARY

Over 10 years of experience in Research. Dependable and accomplished professional with extensive healthcare experienced educating and providing continuity of care to patients. Excellent in problem solving and interpersonal skills. Proven in adaptability and to deal in high paced and stressful environments.

PROFESSIONAL EXPERIENCE

Site Director, Regulatory Specialists/ Quality Assurance and Lead CRC November 2015 – January 2022

Core Healthcare Group with Dr Francisco Badar

Cerritos CA

Knowledgeable in FDA regulations and GCP guidelines

Recruiting, screening, enrolling, and conducting the follow-up of study participants Meet enrollment and retention goals

Schedule and participate in monitoring and auditing activities

Experienced in preparing, submission and maintaining IRB approval materials Working knowledge of MS Office suite, Electronic Data Capture Systems Point of contact for the sponsor and monitoring visits

Managing a team of 3 other Clinical Research Coordinators

Primary contact for all upcoming studies presented by Sponsors Work closely with PI to go over budget and negotiated protocols

Decides the timeline and ensures all studies and protocols are completed within timeframe

Led site operations for up to 10-12 protocols a year

Creates source documents for each protocol and study

All regulatory such as IRB submissions, consent forms, protocol reports and amendments, 1572s, start up paperwork and close-out paperwork, and updated regulatory binders when needed

Lead Clinical Research Coordinator July 2013 – November 2015

Capstone Research with Dr. Francisco Badar

Cerritos CA

Knowledgeable in FDA regulations and GCP guidelines

Recruiting, screening, enrolling, and conducting the follow-up of study participants Meet enrollment and retention goals

Schedule and participate in monitoring and auditing activities

Working knowledge of MS Office suite, Electronic Data Capture Systems Point of contact for the sponsor and monitoring visits

Creates source documents for each protocol and study

Clinical Research Coordinator January 2012 – July 2013

Skyline Research with Dr. Francisco Badar

Cerritos CA

Knowledgeable in FDA regulations and GCP guidelines

Recruiting, screening, enrolling and conducting the fo1low-up of study participants Meet enrollment and retention goals

Schedule and participate in monitoring and auditing activities

Working knowledge of MS Office suite, Electronic Data Capture Systems Working knowledge of MS Office suite, Electronic Data Capture Systems Point of contact for the sponsor and monitoring visits

OTHER EXPERIENCE

Medical Doctor 2008

MMC Clinic

Valenzuela, Philippines

Family Medicine 2010

Amosup Hospital

Intramuros Manila, Philippines

EDUCATION

Project Management Professional 2022

Veterans and Youth Career Collaborative

Long Beach, CA

Logistics and Supply Chain Specialists 2022

Veterans and Youth Career Collaborative

Long Beach, CA

General Industry OSHA30 2022

Veterans and Youth Career Collaborative

Long Beach, CA

Our Lady of Fatima University 1990-1994

Bachelor of Science in Zoology

Valenzuela Philippines

Our Lady of Fatima College of Medicine 1995-2004

Bachelor of Science in Zoology

Valenzuela Philippines

Amosup Hospital 2009-2010

Family Medicine

Intramuros Manila, Philippines

LICENSES AND CERTIFICATES

Project Manager, Accredited Certification IO4PM

ClTI training

Basic Life Support Training Licensed MD (Philippines)

General Industry OSHA 30

Logistic and Supply Chain Specialists

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