Resume May 2009 - HMJ

Helga M. Jones

**** ***

Pasadena, TX *****

Home 713-***-****

Cell Phone 281-***-****

E-mail: **********@*****.*** or *********@*********.***

Summary of qualifications

 Five years experience with a local IRB (Institutional Review Board)

 Three years regulatory compliance experience in Oncology (phase I, II and III trials)

 CCRP Certified

 Familiar with applicable federal, state and local regulations regarding conduct of human subject research

 Submissions to the IBC (institutional biosafety committee), FDA (food and drug administration), RAC (recombinant DNA committee at National Institute of Health)

 Strong verbal communication skills.

 Initiate and complete tasks with minimal supervision.

 Computer literate including Word, Excel, PowerPoint, BRAIN (Baylor College of Medicine IRB submission System), MORTI (The Methodist Hospital Research Institute IRB submission system)

 Maintain meeting minutes

 Provide excellent customer service.

Work experience

September 2, 2008 – January 27, 2009 Baylor College of Medicine

Office of Clinical Research

Regulatory Analyst (Research Coordinator III)

Responsibilities:

 Prepare protocol submissions to the IRB and FDA (approximately 20 studies)

 Maintain the regulatory binders for clinical trials

 Interface with governmental agencies on project/products as identified by the regulatory manager

 Set up regulatory files for monitoring visits and interact with monitors

 Participate in submissions of INDs (investigational drug)

February 1, 2008 – August 29, 2008 The Methodist Hospital

Genitourinary Oncology Program

Quality Improvement Specialist

Responsibilities:

 Providing internal auditing for the Genitourinary Oncology Program (GUOP) for Phase I & Phase II Investigator Initiated trials.

 Write formal audit reports to the director of the GUOP

 Write and update Standard Operating Procedures as needed

 Provide staff education regarding federal and institutional requirements regarding human subject research

 Participate in submissions of INDs and federal grant submissions

February 2006 – February 1, 2008 The Methodist Hospital

Genitourinary Oncology Program

Senior Regulatory Compliance Specialist

Responsibilities:

 Prepare protocol submissions to the IRB, FDA, IBC and RAC (approximately 20 studies)

 Administrator for the GU Oncology DSMB

 Attend DSMB meetings

 Maintain the Regulatory Binders for all clinical trials

 Interface with governmental agencies on project/products as identified by the Regulatory manager

 Set up regulatory files for monitoring visits and interact with monitors

July 16, 2005 – February 2006 The Methodist Hospital

Genitourinary Oncology Program

Regulatory Compliance Specialist

Responsibilities:

 Prepare protocol submissions to the IRB, FDA, IBC (approximately 20 studies)

 Maintain the Regulatory Binders for all clinical trials

 Interface with governmental agencies on project/products as identified by the Regulatory manager

 Set up regulatory files for monitoring visits and interact with monitors

August 1, 2004 – April 30, 2005 MD Anderson Cancer Center Houston TX

Research Administrative Compliance Specialist

Responsibilities:

 Review of all chart review and laboratory protocols to ensure all pertinent information is present prior to sending to the Vice-Chair of the IRB (approximately 80 studies per month)

 Respond to e-mails and phone calls related to the chart review and laboratory protocols

 Send memos to the investigators regarding their protocols

 Maintain files (federal and accrediting agency files, communications, etc.)

October 11, 1999 – July 30, 2004 Baylor College of Medicine Houston, TX

Assurance Coordinator / Administrative Support Coordinator

Responsibilities:

 Maintain working knowledge of applicable institutional policies, federal, state and local regulations regarding conduct of human research

 Act as a point of contact for the community

 Provide support to all 6 IRB’s and analysts (approximately 150 studies a month)

 Teach monthly BRAIN-Training class (Online IRB submission program)

 Offer one-on-one BRAIN instruction to the community

 Respond to all incoming IRB e-mail and phone calls

 Provide continuing education to board members

 Establish anticipated quorum for each meeting

 Draft and send post-meeting memos to investigators

 Administrative review and approval of minor amendments

 Review protocols to ensure all pertinent information is present prior to the IRB meeting

 Review consent forms to make sure it is written in understandable language to subjects

 Type variety of forms, correspondence and other documents from rough notes and drafts

 Maintain files (federal and accrediting agency files, communications, etc.), especially electronic files via BRAIN.

 Maintain office supplies for office function; identify Audiovisual/technical solutions to electronic review difficulties.

Accomplishments

 Developed institutional SOP for BRAIN system

 Developed community education program for BRAIN system

1997 – October 5, 1999 J. A. Majors Co. Houston, TX

Accounting Specialist

 Accounts payable, filing weekly cash reports with corporate office, responsible for credit card processing, match vendor credits with debts, some filing. Responsible for maintaining the computer programs.

1991-1996 White's Concrete & Pottery Pasadena, TX

Accounting / Customer Service Representative

 Accounts receivable-Accounts payable, sales, Lotus, 10-key touch, light typing, EDI, answering phones, invoicing, collections, customer service, ordering supplies.

Certification: CCRP

Education

 2002 - Present San Jacinto Community College Pasadena, TX

 Currently Enrolled

 1983 Graduate – Pasadena High School

 Seminar – How to monitor Clinical trials for GCP compliance (May 1&2 2008)

 Attended numerous education sessions regarding research compliance.

References Available upon request.

Volunteer experience/other interests

Photography

 Some work displayed in www.houstoncameraexchange.com/ (zoo workshop July 2008)

 Taken Portrait Photography; Introductory/Intermediate Professional Photography at San Jacinto College

 Member of the Pasadena Citizen Police Academy since August of 1999. Elected to the secretary position May 2001 to May 2003. Reelected secretary November 2007. Certified with the Search and Rescue Team for the Pasadena Police Department.

 Volunteer for The Periwinkle foundation, which develops and provides programs that positively change the lives of children, young adults and families who are challenged by cancer and other life threatening illnesses and are cared for at Texas Children's Hospital.

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