ERICA M. FELIX
Buena Park,CA
Summary
Skilled Regulatory Affairs Coordinator with deep understanding of global regulatory requirements and procedures. Strong background in coordinating documentation, preparing submissions, and tracking regulations for compliance within the pharmaceutical industry. Demonstrated strengths in project management, effective communication, and team leadership; known for driving process improvements to enhance efficiency and accuracy. Proven ability to contribute positively to cross-functional teams while ensuring adherence to all relevant regulatory standards.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Clinical Research Associate II, Specialist - TMTT
Edwards LifeSciences
Irvine, CA
06.2021 - 02.2024
- Performed study start-up and conduct activities including ICF review that meets regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities
- Identified and investigated discrepancies in study documentation by applying clinical protocol and GCP knowledge, develop processes to mitigate recurrence throughout study phases
- Conducted in-house and site (if applicable) reviews of associated documentation and participate in internal and competent authority, audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Edwards internal SOPs, and US and OUS regulations
- Assess current processes, identify opportunities and propose solutions to improve process efficiency within and across related functional areas
- Partnered with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution
- Assisted with clinicaltrials.gov updates
Regulatory Affairs Coordinator I
Long Beach Medical Center/ Miller Children's & Women's Hospital
Long Beach
03.2019 - 06.2021
- Coordinated regulatory activities for multiple clinical research projects across multiple therapeutic areas from site selection to closure
- Managed and oversee new study initiation process and provide regulatory guidance/support including consent form development, HIPAA authorization form and other IRB required forms/submissions
- Oversees reporting of AEs, SAEs, IND safety data, violations, deviations and submission of other study documents to support regulatory compliance, and troubleshoots processes and procedures when issues are identified
- Prepared and assisted in submission of protocol amendments, IND safety reports, consent form changes, and continuing reviews
- Working knowledge of internal SOP's, FDA/lCH guidelines to GCP's and regulatory compliance
- Worked closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory authorities
- Created, reviewed and revised all functional group SOP's
- Maintained current and accurate documentation in the eTMF and CTMS
Regulatory Coordinator
American Institute of Research
Whittier, CA
12.2014 - 03.2019
- Managed departmental regulatory aspects for clinical trial and research activities
- Provided reporting of all regulatory activities to department leadership
- Assisted in formulating departmental policies and guidelines
- Developed, maintained, and updated all internal and external protocols, data collection sheets, spreadsheets, and databases for use in gathering and compiling information specific to each research process
- Serves as the site regulatory contact for sponsored projects and assists with all site initiation and monitoring visits
- Completed and maintained regulatory documents for all study personnel, including curriculum vitae, license, bio sketches, financial disclosures, Form FDA 1572, confidentiality agreements, and delegation of duties logs
- Collaborated with departmental staff and faculty to develop and complete necessary documentation for continuing renewals, amendments, and modifications, including the writing of consents, querying of systems to determine enrollment, and review of data safety monitoring reports
Personal Lines Insurance Agent
Arrowstar Insurance Services
Burbank, CA
06.2011 - 04.2013
- Promotes and sells personal lines insurance products and services to existing and prospective clients
- Provides excellent customer service over the phone and in person for personal lines client
Customer Service Representative
Wholesale Insurance Services
Santa Ana, CA
03.2007 - 05.2011
- Provides customer service for the personal lines of insurance
- Interacts with customers by phone or in person to ensure the best service possible
- Process information concerning pricing, changes in coverage, and discontinuance
- Investigates and corrects errors, following customer and company
Education
Licensed Vocational Nursing -
Advance College
South Gate, CA01.2009
Caregiver Program -
Philippine Women's University
Philippines08.2005
Bachelor of Science - Business Administration Major in Management
Ateneo University
Philippines03.2001
Skills
- Attention to detail
- Organizational skills
- Ability to prioritize
- Regulatory knowledge
- Familiarity with Code of Federal Regulations and state laws
- Familiarity with institutional policies and procedures
- Good Clinical Practice Guidelines
- Ability to handle confidential information
- Self-motivated
- Excellent interpersonal skills
- Verbal communication skills
- Written communication skills
- Familiar with online software's such as CTMs, EDC, Veeva Vault, eTMF
- Familiar with e-reg platforms such as Complion, Florence etc
Certification
- LVN Certificate
- CITI Biomedical Certificate
- Good Clinical Practice Certificate
Languages
Tagalog
Full Professional
References
References available upon request.
Timeline
Clinical Research Associate II, Specialist - TMTT
Edwards LifeSciences
06.2021 - 02.2024
Regulatory Affairs Coordinator I
Long Beach Medical Center/ Miller Children's & Women's Hospital
03.2019 - 06.2021
Regulatory Coordinator
American Institute of Research
12.2014 - 03.2019
Personal Lines Insurance Agent
Arrowstar Insurance Services
06.2011 - 04.2013
Customer Service Representative
Wholesale Insurance Services
03.2007 - 05.2011
Licensed Vocational Nursing -
Advance College
Caregiver Program -
Philippine Women's University
Bachelor of Science - Business Administration Major in Management
Ateneo University
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