Evelyn Huang, MPH, CHRC, CCRA, CCRC

New York, NY 917-***-**** acebhg@r.postjobfree.com

EDUCATION

Lehman College, The City University of New York, Bronx, NY

• Master of Public Health, 2006-2009; Specializing in Public Health Policy and Administration

• Select course work include: Biostatistics, Epidemiology, Public Health Policy and Administration, Research Methods, Program

Planning and Evaluation, Community Assessments, Grant Writing, Nutrition and Chronic diseases, Statistical Analysis ( SAS,

SPSS) and more

Guangzhou Medical College, Guangzhou, China

• Medicine, 1993-1998

• Course work include: Human Anatomy, Pathologic Anatomy, Biochemistry, Physiology, Histology & Embryology, Immunology,

Pharmacology, Preventive Medicine, Medical Statistics, Internal Medicine, Surgery, Obstetrics & Gynecology, Pediatrics,

Neurology & Psychiatry, Infectious Disease & Epidemiology, Ophthalmology, Dermatology, Radiology, Diagnostics and more

New York University School of Medicine, New York, NY

• 2002, course work in “Introduction to Medical Interpretation”

Borough of Manhattan Community College, The City University of New York

• 2002, course work in Sociology and English Composition

AREAS OF EXPERTISE

• Experience and knowledge working with a wide range of research regulatory compliance areas including GCPs, IRB,

OHRP, FDA IND/IDE requirements and inspections, New York State law, grants financial management, conflicts of

interest, HIPAA privacy & security, standard operational procedures, study vendor and investigational product

compliance

• Over 7 years of experience in clinical research design, protocol development and implementation, and study conduct

• More than 3 years of implementation of GCP auditing and IND monitoring programs

• Solid experiences in root cause analysis

• Excellent skills at drafting auditing reports and presenting analysis results

• Excellent analytical skills including problem solving, risk assessment, and impact analysis

• Excellent conflict management and interpersonal skills

• Executive report and paper/abstract writing and professional presentations

• Proficient in metrics development and quantitative and qualitative analysis (SPSS) including trend analysis

• Proficient in PC, Microsoft Office and Adobe Programs such as Professional and Photoshop

CERTIFICATIONS

• CHRC- Certified Healthcare Research Compliance Professionals

• CCRA- Certified Clinical Research Associate, accredited by Association of Clinical Research Professionals

• CCRC - Certified Clinical Research Coordinator, accredited by Association of Clinical Research Professionals

• Certificate for Chinese/English Medical Interpretation – Course taught by NYU School of Medicine, I was later hired as an

instructor for this course

PROFESSIONAL EXPERIENCE

North Shore-Long Island Jewish Health System, NY – Manager, Office of Research Compliance, Auditing and Monitoring

Division 2011-Present

• Proficient with GCP, ICH, OHRP, NIH, DOD and FDA regulatory requirements. Provide comprehensive regulatory guidance to

the research community to ensure the responsible conduct of research;

• Involve in reviewing and developing of written standards of conduct, as well as written policies and procedures compliant with

institutional, state and federal regulations;

• Conduct auditing and monitoring of research including regular or for-caused Good Clinical Practice (GCP) reviews for human

subject research in research throughout the entire health system’s 15 hospitals;

• Focus on the Research HIPAA Privacy and Security Compliance, facilitate the Research Information Security Committee and

Conduct regular or for-caused focused reviews of HIPAA compliance related to research projects, vendors involving the use of

Protected Health Information;

• Respond to allegations or audit findings of improper/illegal activities and the enforcement of appropriate disciplinary action

against employees who have violated internal research polices, applicable state law, regulation or federal requirements;

• Provision of regulatory support for investigator-initiated, sponsor-investigator studies, including developing risk-based

monitoring plan and providing monitoring services for the conduct of multicenter clinical trials at local and national sites;

• Respond to concerns from faculty, staff, research participants, and federal agencies with the adoption of procedures to protect the

anonymity of complainants and to protect whistleblowers from retaliation;

• Assure consistency and appropriateness of audit observations, reports and /or compliance assessments for GCP audits. Present

major significant issues to the IRB review committee and health system leadership.

• Provide recommendations for corrective and preventive actions development and process. Monitor implementation of CAPAs as

determined through investigations and follow up on CAPAs effectiveness review;

• Assist sites to prepare for and / or respond to external audits from state and federal agencies, sponsors etc. Conduct pre-review

before the external audits as requested;

• Conduct risk assessment for research compliance issues;

• Assist sites to develop, implement and evaluate the internal quality assurance programs as requested;

• Develop and implement regular, effective education and training for all personnel engaged in research;

• Develop and conduct specified Continuing Medical Education (CME) sections focusing on quality assurance such as: Internal

Quality Assurance and Management, Corrective and Preventive Action Plan (CAPA) for GCP noncompliance, and Good

Documentation Practice, etc;

• Develop templates and tools for auditing and monitoring activities, and for conduct of research;

• Coordinate and conduct reviews and investigations related to the following areas: billing and financial and grants management

areas; drug and device accountability; vendor’s services; and research misconduct;

• Serve as the research liaison to North Shore-LIJ Health System privacy and risk committees; Liaise with all components of the

Research Compliance Program and any non NSLIJ health system Institutional Review Board including clinical trials reviewed

and approved under the Biomedical Research Alliance of New York (BRANY); serve as the research compliance liaison to the

Hofstra-North Shore-LIJ School of Medicine;

Monter Cancer Center, North Shore Long Island Jewish Health System, NY – Manager, Data Research 2009-2011

• Supervises implementation of phase II and III Gynecological Oncology trials at 4 different research sites involving Gynecology

Oncology patients

• Coordinates with trial sponsors from site-initiation to study close-out. Responsible for prepping trial teams on protocols, and

managing day-to-day activities of on-going trials

• Monitors patient recruitment & enrollment, protocol adherence, and investigator performance

• Maintains regulatory compliance and reporting (IRB reviews, informed consent form modifications, SAE reports, etc.)

• Develops reporting systems for data collection to ensure data quality and integrity

• Oversees Case Report Forms (CRFs) completion and timely submission to sponsors

• Maintains source documentation and drug accountability

• Tracks financial activities associated with protocols/research projects

• Responsible for training clinical research staff on Federal guidelines for research on human subjects

• Responsible for internal quality assurance; self-audit for identifying any GCP noncompliance and preparing for external audit

and monitoring

Saint Vincent’s Comprehensive Cancer Center, New York – Senior Clinical Research Coordinator 2008-2009

• Managed Phase I to III clinical trials conducted by principal investigators in the Hematology/Oncology division

• Coordinated research activities with Pharmaceutical companies, Biotechs, CROs, and Central Labs from site initiation to

trial close-out

• Responsible for planning activities such as protocol training and preparation for site initiation.

• Developed regulatory reports for the IRB, case report forms, questionnaires, SOPs, and more

• Screened and recruited patients for clinical trials

• Conducted data collection, compilation, documentation, and verification with patient charts

• Collaborated with PIs on data interpretation and preparation of manuscripts for publication

Dobbs Consulting, LLC, New York - Consultant 2010-2010

2006-2010

• Advises clients on issues regarding clinical trial management & monitoring, quality assurance, data management, training, and

medical writing

• Provides input on general inquiries about Oncology trials

• Conducts safety reviews of the source documents against the reported adverse events, and GCP noncompliance

New York University – Course instructor 2010-Present

• Instructor for “Chinese Medical Interpretation” class offered by NYU’s School of Continuing and Professional Studies

• Teaches standard methods of medical interpretation to hospital professionals

• Supervises live clinical interpretation by students

Saint Vincent’s Chinatown Clinic, New York – MPH Intern 2008-2008

• Conducted a patient satisfaction study for the clinic

• Developed and translated the patient satisfaction questionnaires

• Facilitated study pilot with clinic staff and collected survey data

• Summarized survey findings and made recommendations to address areas for improvement

Saint Vincent’s Hospital Manhattan, New York - Patient Educator & Medical Interpreter 2002-2007

• Provided group and one-on-one education to patients to help patients make informed decisions, maximize self-care, and enhance

recovery

• Developed education resources for patients that promoted Health Wellness

• Performed Chinese language interpretation and translation

• Resolved cultural barriers between immigrant patients and healthcare providers

Merck China, Guangzhou, China – Marketing Specialist 1999-2001

• Helped establish and administer a State-Wide HealthCare Net marketing program in Sothern China. The program was similar to

Merck’s “Live Life Well” program in the USA

• Planned quarterly promotional activity targets within budget for marketing team members

• Monitored promotional activities such as city-wide physician conferences, patients lectures in the hospitals and communities,

and training programs for health care professionals

• Coordinated promotional activities with regional sale managers in 4 different cities

The 4th Guangzhou Municipal Hospital – Intern 1997-1998

• Completed the mandatory internship that was a part of my bachelor of medicine degree

• Examined and diagnosed patient illnesses, prescribed and administered medical treatments

• Helped educate patients from different backgrounds on medical terminology, risks of the tests and procedures, precautions and

side effects of medications.

• Participated in medical research activities

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