SOPITA LAPSOMPHOP, M.S.

**** ***** ***** ****. #****

San Diego, California 92122

703-***-****

Email: abnf5j@r.postjobfree.com

EDUCATION

University of Maryland, May 2008

Major: Masters of Science in Management/Health Care Administration

Masters of Business Administration, expected Dec 2010

George Mason University, May 2003

Major: Bachelor of Science, Biology

Concentration: Microbiology/Infectious Diseases

Minor: Psychology

THERAPEUTIC EXPERIENCE

Cardiovascular: Congestive Heart Failure

Dermatology: Chronic Skin Conditions, Hypotrichosis

Infections/Parasitic Diseases: Human Immunodeficiency Virus

Endocrinology/Metabolism: Diabetes mellitus

Pulmonary/Respiratory: Asthma, Allergy

Nervous System: Multiple Sclerosis

Transplants: Liver, Kidney

Urology: Androgen, Benign Prostatic Hyperplasia

RELEVANT EXPERIENCE

Senior, Clinical Research Associate November 2009-Present

Allergan (contract via Adecco), Irvine, California

Prepares, collects, and tracks master study level documents and site non-regulatory documents

Administers key clinical systems, produces reports on key clinical metrics, and supports clinical operations

Performs the activities associated with the evaluation, initiation, monitoring and collection of data, and closeout of

clinical pharmacology trial sites

Aligns execution activities with agreed upon project priorities, timings and quality specifications

Review study Case Report Forms (CRFs) completed by the investigative sites, and verifying entries by validating accurate source

documentation to support CRF entries

Document site visits and issues in reports and follow-up letters to the site

Facilitate effective communication between investigative sites, the client and vendors

Identify potential countries, sites and investigators in collaboration with the study team

Respond to company and federal regulatory requirements/audits

Contribute to the project team by mentoring new members, assist in preparation of project communications and tools, and sharing ideas

and suggestions with team members

Manage all required clinical study protocols, amendments or deviations

Manage clinical trial sites and develop clinical program timelines, budgets and strategies

Assure timely initiation and completion of clinical studies.

Ensure essential regulatory documents are present and up to date

Assist in the completion and collection of regulatory documents

Ongoing and continual communication with the clinical site and study team/personnel throughout the duration of the study

Clinical Research Manager/Medical Writer III February 2009-September

2009

Johnson & Johnson (contract via Apex Systems), San Diego, California

Able to assume high level R&D operational oversight of global clinical trials from protocol design to Clinical Study

Reports

Serves as the primary interface between Clinical Research & Development and Site Management/Monitoring Organization and ensures

consistency across studies in a program

Operational contact to the Core Team and able work in partnership with Clinical Program Lead

Design, develop and write protocols, informed consent forms, source documents, CRF/eCRF guidelines, study guides,

subject leaflets and project specific forms to be utilized during the study

Provide input to clinical development plans, timelines, resources and assists with obtaining feasibility information with

regard to study design and site eligibility and selection

Leads all study management team and clinical sub team meetings while facilitating communication between cross- functional teams

Identify, recruit and select new investigators, sites, contract research organizations and outside vendors

Assist in the compilation/writing of clinical sections of regulatory submissions for IND and CTA for Health Authorities

Provide protocol, cost drivers and assumptions, and study task list to site management organizations

Contribute to specification development for trial execution and data management

Coordinates post-database lock activities related to statistical analysis and report writing

Coordinate the activities associated with the evaluation, initiation and management of clinical trials

Coordinate clinical and regulatory activities with company ex-US offices

Lead in the selection and implementation of clinical sites

Contribute to the preparation of clinical protocols and amendments

Support the preparation and submission of regulatory reports and clinical study reports

Provide technical, scientific, and administrative assistance to the department

Manage vendors and communicate with sites and others within the company, both in, and outside the department.

Coordinate the organization of investigator meetings

Track CRO and third party vendor activities

Identify, select, and implement clinical sites

Coordinate the activities associated with start up and management of clinical sites

Ensure budgets, schedules, and performance requirements are met

Monitor progress of studies identifying delays and initiation of corrective actions when necessary

Clinical Research Associate June 2008-November 2008

Pharmaceutical Product Development, Inc., San Diego, California

Identified potential investigators in collaboration with the client company to ensure the acceptability of qualified

investigative sites

PPD Clinical Foundation Program: Global Learning and Performance. Wilmington, NC June 2, 2008 – June 13, 2008

Performed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs

to assess the safety and efficacy of investigational products and/or medical devices

Conducted pre-study, study initiation, routine monitoring, and study closeout visits

Developed collaborative relationships with investigative sites and client company personnel

Created monitoring tools and contributed to the project team

Assisted in preparation of project publications/tools and sharing ideas/suggestions with team members

Developed source documents, CRF/eCRF guidelines and project specific forms to be utilized during the study period

Clinical Project Manager/Health Specialist November 2004-May 2008

National Institute of Health/National Institute of Allergy & Infectious Diseases, Bethesda, Maryland

Monitored progress of studies identifying delays and initiation of corrective actions when necessary

Liaison with the clinical sites in order to answer protocol related questions and guide the implementation process.

Facilitated communication amongst the project team and maintained study timeliness

Reviewed all study related materials and distributed study documents to the clinical sites for submission to the Institutional Review

Board

Provided training to clinical site study staff and participated in pre-study and site initiation visits

Reviewed site-monitoring reports and ensured corrective actions are outlined when protocol violations and/or compliance issues are

identified

Ensured that essential documents are collected from the clinical sites in accordance with GCP and existing Standard Operating

Procedures

Generated progress reports and other deliverable project documentation via spreadsheets and graphs

Tracked, reviewed, and distributed metric updates (regulatory, enrollment, CRF retrieval, subject visits, query, etc.) to directors

Developed protocols, informed consent forms, source documents, CRF/eCRF guidelines, study guides, subject leaflets and project

specific forms to be utilized during the study

Coordinated the organization of investigator and coordinator meetings

Interfaced with task and functional leaders, subcontractors, and support personnel

Responsible for planning, organizing, directing and tracking major aspects of projects, including technology, schedules, costs, and

contract/customer satisfaction

Analyzed the effectiveness of organizational projects and made changes when needed

Reviewed essential regulatory documents prior to transmittal to FDA for release on initial investigational product

Provided leadership and directional management for daily operations

Coordinated clinical trials from protocol development, implementation to close out activities

Performed review of pass-thru travel costs to ensure the most cost-effective travel practices were being utilized by monitoring staff

Managed clinical budget; escalated out of scope activities to the appropriate individuals for inclusion in a contract modification

Managed clinical resources (CRAs/administrative team) according to projections of ongoing clinical activities to ensure maximum

resources were allocated to maintain forward movement of clinical deliverables

Prepared scientific presentation material for meetings, conferences, lectures and study site visits

Manager, Science and Technology July 2003-October 2004

PDA, an International Association for Pharmaceutical and Biopharmaceutical Science and Technology, Bethesda, Maryland

Acted as staff liaison and give support to task groups, subcommittees and interest groups

Scheduled meetings, teleconferences, and appointments for technical and regulatory committees and task groups

Organized and managed the Science Advisory Board, Regulatory Affairs and Quality Committee, Industry Advisory Board and

subcommittees

Maintained and created departmental budget and purchase orders

Edited draft technical reports and other documents prepared by the task groups and subcommittees

Moderated the Pharmaceutical Sci-Tech Discussion Group

Wrote monthly for the PDA letter about Scientific and technical issues

Managed committee and task group support for scientific, technical and regulatory affairs projects including membership and project

lists, communications, distribution of meeting summaries and tracking action items.

Registered PDA members into appropriate conferences and courses

Created and applied batch transactions for registration, membership and UBS wire transfer

Coordinated processing of applications, completion certificates, and re-qualifications for the ARC (Audit Repository Center)

Auditor Training Courses

Distributed and tabulated ballots for PDA’s Science Advisory Board and Regulatory and Quality Committee. Follows up as

necessary to assure timely responses

Provided administrative support for the Vice President of Science and Technology and the Director of Regulatory Affairs

Summarized new scientific, regulatory and technical information as appropriate and assigned

Webmaster with DreamWeaver to post updates to the Science and Technology website section

LICENSES & CERTIFICATIONS

Certified Good Clinical Practices, Eduneering, Fall 2005

PROFESSIONAL DEVELOPMENT

Project Management, Association for Clinical Research Professionals, Arlington, VA, Sep 2006

Fundamentals of Clinical Research, Association for Clinical Research Professionals, Arlington, VA, Nov 2004

Good Manufacturing Practices, Parenteral Drug Association, Bethesda, MD, Aug 2003

PROFESSIONAL AFFILIATIONS

Member of the Association of Clinical Research Professionals since 2003

Member of Parenteral Drug Association since 2003

Member of the Drug Information Association since 2003

COMPUTER EXPERIENCE

Windows XP, Windows Vista, MS Word, MS Excel, MS Access, MS Outlook, Adobe Acrobat Professional

LANGUAGES

Proficient in Thai

Intermediate in Spanish

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