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ANA LIZA YANGCO CHEN
Clinical Research Coordinator
Irvine,CA
Summary
Versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities.
Overview
26
26
years of professional experience
12
12
years of post-secondary education
17
17
Certifications
2
2
Languages
Work History
Clinical Research Coordinator
Orange County Research Center
Tustin, CA
05.2022 - Current
- Followed informed consent processes and maintained records.
- Gathered, processed, and shipped lab specimens.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
Senior Clinical Research Coordonator
Hawaiian Gardens Clinical Trials
Hawaiian Gardens, CA
12.2012 - 12.2019
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Followed informed consent processes and maintained records.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Maintain study records, drug dispensation record, any case report forms as per FDA /IRB guidelines
- Developed and maintained accurate and up-to-date case report forms and source documents.
Senior Research and Regulatory Coordinator
Epilepsy Clinic Of Southern California
Newport Beach, CA
03.2007 - 12.2012
- Prepared and submitted regulatory file applications and supporting documentation.
- Reviewed documents and data to assess compliance with IRB regulations.
- Prepares and submits regulatory documents to Sponsor and IRB and works with clinical research team to ensure submission documents are up-to-date.
- Manages regulatory activities for all stages of clinical trials for assigned department
- Maintains a working knowledge of all federal, state, and institutional guidelines regarding clinical trials
- Provides guidance and training to research staff to ensure compliance with rules and regulations associated with clinical research studies.
- Prepare and submit start-up regulatory packets to Sponsor and IRB
- Monitor approval status of open studies by completing timely reviews
- Serve as a liaison to Sponsors/CRO/IRB/Investigators assuring continuity of service and problem resolution
- Perform study procedures in accordance with GCP and study protocols
- Mentor and lead less experienced coordinators and/or research assistants
- Organize and maintain paper and electronic study data in a complete and correct manner
Clinical Research Coordinator
B.P. Center Clinical Trials, Inc
Buena Park, CA
06.2003 - 02.2007
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Gathered, processed, and shipped lab specimens.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Ensure protocol adherence and accuracy of research data and transcription into data capture systems where appropriate
- Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study by working with the PI, SI, department, sponsor, and company
- Organize and conduct clinical study using good clinical practices (GCPs
- Upload documents such as labs, other clinical documents, informed consent documents into established clinical trial management systems and/or electronic trial master file
Surgical Coordinator
Montebello Surgical Center
Montebello, CA
06.2002 - 06.2003
- Coordinated with facilities to set up surgeries.
- Educated patients about surgeries and provided treatment plan documentation.
- Checked patients in and out and collected payments.
- Verified insurance coverage and obtained pre-authorizations.
- Answered telephone calls to offer office information, answer questions, and direct calls to staff.
- Expertly managed planning, scheduling, and coordination of outpatient procedures.
- Arranged pre-operative and post-operative appointments for surgical patients.
- Prepped operating rooms and booked necessary equipment and supplies.
- Took pre-operative orders from surgeons and anesthesiologists for smooth operation planning.
- Communicated surgery requirements to nursing teams for smooth operation delivery.
- Obtained pre-authorizations and pre-certifications ahead of scheduled surgeries.
- Collated pre-operative lab and imaging results to facilitate surgery planning.
- Updated patient records to reflect upcoming surgeries and medical histories.
- Updated daily operating room calendars with accurate appointment schedules.
Medical Assistant
HANA Medical Group
Buena Park, CA
06.2002 - 06.2003
- Called and faxed pharmacies to submit prescriptions and refills.
- Completed clinical procedures and gathered patient data for interpretation by physician.
- Collected and documented patient medical information such as blood pressure and weight.
- Taught patients about medications, procedures, and care plan instructions.
- Directed patients to exam rooms, fielded questions, and prepared for physician examinations.
- Kept medical supplies in sufficient stock by monitoring levels and submitting replenishment orders before depleted.
- Documented vital signs and health history for patients in clinic and hospital environments.
- Scheduled appointments, registered patients, and distributed sample pharmaceuticals as prescribed.
- Assisted with routine checks and diagnostic testing by collecting and processing specimens.
- Obtained client medical history, medication information, symptoms, and allergies.
- Sanitized, restocked, and organized exam rooms and medical equipment.
- Verified patient insurance coverage and collected required co-payments.
- Assisted physicians with minor surgeries, including preparing operating room and sterilizing instruments.
- Collaborated with medical and administrative personnel to maintain patient-focused, engaging and compassionate environment.
- Oriented and trained new staff on proper procedures and policies.
- Prepared lab specimens for diagnostic evaluation.
- Updated inventory, expiration and vaccine logs to maintain current tracking documentation.
- Liaised with patients and addressed inquiries, appointment requests and billing questions.
- Completed EKGs and other tests based on patient presentation in office.
- Collected pertinent data and calculations to aid physician in interpreting results.
- Measured patient spirometry.
- Helped improve patient outcomes by educating and advising on relevant treatments and care.
In House Physician
Rowell Industrial Corporation
Manila, Philippines
01.1998 - 05.2002
- Took leading role in delivery of healthcare services and regularly reviewed services to spot trends or errors.
- Completed basic in-office procedures with local or topical anesthetic.
- Thoroughly examined patients and elicited medical history data to use in assessing health and identifying conditions.
- Delivered emergency treatment on-site and responded appropriately in urgent or emergency situations.
- Assessed, diagnosed and treated emergency and chronic medical conditions.
- Supervised care given by other professional or non-professional personnel and instructed on proper techniques.
- Conducted on-site sick call and chronic care clinics for patients.
- Collaborated with consulting physicians regarding care of patients.
- Accessed patient health through interviews and physical examinations.
- Evaluated patient histories, complaints, and current symptoms.
- Diagnosed and treated patients suffering from chronic conditions.
- Identified serious conditions and emergency situations and immediately referred to hospital for prompt care.
- Volunteered at community health clinic to provide high quality care for low-income and indigent patients.
- Provided emergent medical care and treatment for life-threatening injuries and illnesses.
- Participated in patient education sessions among targeted populations with prevalent health risk factors.
Education
Associate of Science - Nursing
Saddleback College
Mission Viejo, CA 08.2008 - 12.2010
M.D. -
Perpetual Help College of Medicine
Manila,Philippines 06.1991 - 05.1997
Bachelor of Science - Biology
University of Santo Tomas
Manila, Philippines 06.1987 - 05.1991
Skills
Research SOPs understanding
Certification
Disaster Cadre I
Software
Excel
Interests
Interested to learn new things and grow professionally
Timeline
ERT
08-2023
Vault CDMS
07-2023
ICH GCP
10-2022
Clinical Research Coordinator
Orange County Research Center
05.2022 - Current
First Aid
05-2022
CPR
05-2022
CITI PROGRAM (GCP,HIPS for Clinicians)
05-2022
Dangerous Goods Transport
05-2022
Medical Compliance
05-2022
RAVE/Medidata
05-2022
Florence
05-2022
Basic Life Support
01-2022
Pediatric Lifer Support
01-2022
Advance Cardiac Life Support
01-2022
Disaster Cadre I
12-2021
Community Emergency Response Team
05-2015
Senior Clinical Research Coordonator
Hawaiian Gardens Clinical Trials
12.2012 - 12.2019
Associate of Science - Nursing
Saddleback College
08.2008 - 12.2010
Senior Research and Regulatory Coordinator
Epilepsy Clinic Of Southern California
03.2007 - 12.2012
Clinical Research Coordinator
B.P. Center Clinical Trials, Inc
06.2003 - 02.2007
Phlebotomy
04-2003
Surgical Coordinator
Montebello Surgical Center
06.2002 - 06.2003
Medical Assistant
HANA Medical Group
06.2002 - 06.2003
In House Physician
Rowell Industrial Corporation
01.1998 - 05.2002
M.D. -
Perpetual Help College of Medicine
06.1991 - 05.1997
Bachelor of Science - Biology
University of Santo Tomas
06.1987 - 05.1991
PFIZER per protocol
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