Clinical Manager

Sharon Ruben, MS; BS

***** ******** ****

Dumfries, VA 22026

Phone: 571-***-****

E-mail: ***************@***.***,

EXECUTIVE SUMMARY

Extensive experience in clinical trial management spanning protocol development, Case Report Form

(CRF) Design, site monitoring, data collection, safety report writing, drug accountability and training of clinical site staff. Passionate about medical writing, and working with study investigators to advance science through the clinical research process. Authored and fast-tracked HIV/AIDS protocol for NIH which became the first expedited clinical trial to get to the field. Record of a high degree of quality work, exceptional presentation skills and ability to assemble and work with doctors, nurses, clinical site staff and other clinical management executives.

CORE COMPETENCIES

• Translation of scientific information into publications, medical writing/editing;

• Exceptional research skills; very knowledgeable about health and disease-related topics;

• Clinical trial protocol development – cardiovascular, HIV/AIDS (adults & pediatrics), oncology;

• Flexible writing style suiting reading audience from layman’s terms to technical;

• Knowledge of PubMed and research;

• Ability to read, interpret and summarize tables, charts and graphs;

• Clinical trial monitoring and all aspects of study site management;

• Effective time management skills;

• Ability to work independently or on a team, high degree of output; organized and detail oriented;

• Self-motivated and driven by the interest of science and research;

• Highly proficient in Microsoft Office: Excel, Word, Power Point WORK EXPERIENCE

Lollipop Listening and Learning Center, - Owner, CEO Present

Opened premier listening center to retrain the ears and brain to listen better for children with autism, ADD/ADHD, dyslexia and other developmental delays using my Lollipop Listening Therapy. www.LollipopListeningandLearningCenter.com.

Sound Therapy Systems, LLC – Owner, CEO 2007 to Present

• Developer of revolutionary listening therapy for children with autism and developmental delays, on- line business; consultant to parents of children with autism, ADD/ADHD, dyslexia and other developmental delays. Hold boot camps to train parents, therapist and doctors in listening therapy. www.LollipopListeningTherapy.com.

Author of published Autism book 2003 and Revised 2010

“Awakening Ashley: Mozart Knocks Autism on its Ear” – the story of my daughter’s full recovery from autism. Amazon.com, www.AwakeningAshley.com.

Medical Writer/Editor 2001-2005

• Life Extension, Inc – Protocol Developer for Disease Prevention and Treatment protocol book

(home-based position).

• Parexel International – Edited Clinical Monitoring and Safety Reports (home-based position). Clinical Trial Manager 1996-1998

• Advanced Biomedical Associates - Developed clinical trial protocols for drug studies, Case Report Form (CRF) design and development, monitored and audited clinical trial studies. Trained clinical site personnel. (monitored 3 sites simultaneously). Clinical Trial Manager 1992-1994

• Westat – Wrote clinical monitoring sections of RFPs, monitored and audited clinical trial studies, data management and data query reconciliation. Presented at Investigator meetings, trained clinical site personnel. (monitored 3-4 sites simultaneously). Protocol Specialist 1992-1996

• Social and Scientific Systems - NIH/DAIDS – Protocol Specialist - AIDS research. Worked with team of doctors, statisticians, data managers and clients at DAIDS (Division of AIDS – NIH) to write clinical trial protocols. Carried a high workload of protocols at a time (ie: worked on no fewer than 7 protocols at a time). Responsible for developing one of the fasted clinical trial protocols for an AIDS trial. Headed up weekly calls with protocol team to develop, edit and approve protocols). Clinical Research Associate 1989-1992

• Otsuka Pharmaceutical - Monitored and audited clinical trials and collected data, responsible for data entry of CRFs into data management system and reconciling data queries, developed Standard Operating Procedures (SOP) for the clinical group, developed Case Report Forms

(CRFs). Trained clinical site personnel. (monitored 4 sites regularly, sometimes more to help other CRAs).

EDUCATION

MS – Biotechnology Management – University of Maryland University College, College Park, MD – 1996 BS – Biology - Mary Washington College, Fredericksburg, VA - 1987 AREAS of RESEARCH and STUDY

Cardiovascular, HIV/AIDS (Adult and Pediatrics), Oncology, Autism and Developmental Delays ACHIEVEMENTS

• Guest on Today Show (NBC) with Katie Couric, Soap Talk with Lisa Rinna, Woman’s World Magazine, Exceptional Parent Magazine, Spectrum Magazine. (See Media Page on Website)

• STAR Author – Iuniverse - 5 out of 5 star CLARION/FORWARD Review of published book,

“Awakening Ashley: Mozart Knocks Autism on its Ear”

• Breast Cancer Survivor – 11 years

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