Resourceful and detail-oriented Healthcare professional with 19 years in the industry. Proven skills focused
on clinical trial monitoring, site initiation, electronic medical record review, data abstraction, case report
form review, database management, GCP/ICH and FDA regulation compliance, and regulatory submission.
Therapeutic areas of expertise include: Oncology, Phases I - II Oxygen Therapeutics, Phases I - II Cardiac
medical device, Phase III
Skill Highlights
Clinical Trial Monitoring
Medical Record Review
Data Abstraction
EMR Systems
Auditing
Medical Terminology
Project Management
FDA regulations
Good Clinical Practice
Regulatory submission
Database Management
SOP Development
MS Office
MS Excel
Education and Training
University of Massachusetts, Expected in 1986 ā āMaster of Arts:Applied Sociology - GPA:Applied Sociology
Eastern Nazarene College, Expected in 1983 ā āBachelor of Science:Biology - GPA:Biology
Professional Experience
Abm - Appen Meridian, ID, 08/2015 - 12/2016
Provided social media support utilizing platforms such as Facebook and Twitter to improve the
relevancy of the news feed.
Conducted research, performed evaluation and feedback of web search engine results of pre-defined
queries.
Acumen Pharmaceuticals Inc. - Field Coordinator Austin, TX, 09/2014 - 11/2014
Project management responsibilities representing Ipsos and Reuters during a state election.
Conducted surveys with local elected officials.
Trained and supervised a group of Election Agents working in the field responsible for gathering
accurate election results utilizing a new smartphone application.
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Acumen Pharmaceuticals Inc. - Life Skills Therapist Gilbert, AZ, 05/2009 - 09/2014
Provided training and supervision to adults with traumatic brain injuries in a residential setting.
Focused on helping individuals gain Independent Living Skills.
Provided instruction according to individualized plans.
Acutus Medical - Clinical Research Associate Boston, MA, 02/2002 - 03/2008
Responsible for extensive travel to monitor Phase I - II Oncology clinical trials.
Performed site initiation and routine monitoring visits.
Educated Principal Investigators and investigative site personnel about protocol requirements.
Audited electronic medical record systems.
Abstracted data from medical records and source documentation to ensure patient safety and veracity
of data.
Ensured clinical trial compliance with GCP/ICH and FDA guidelines.
Cancer Treatment Centers Of America - Clinical Research Associate City, STATE, 07/2001 - 12/2001
Responsible for extensive travel to monitor Phase I - II oxygen therapeutic clinical trials.
Performed site initiation and routine monitoring visits.
Screened and recruited patients for studies.
Abstracted data from electronic medical record review systems to correct data discrepancy listings.
Prepared documents for IND regulatory submissions.
Ensured clinical trial compliance with GCP/ICH and FDA regulations as well as sponsor protocol
requirements.
Boston Medical Center - Clinical Research Associate City, STATE, 01/1997 - 06/2001
Responsible for extensive travel to monitor Phase III clinical trials for a Cardiac medical device
indicated for usage in patients prior to heart transplantation.
Performed site initiation, routine monitoring and study close-out visits.
Reviewed medical records and abstracted data to correct data discrepancy listings.
Prepared Investigator Brochures and related study documents.
Ensured clinical trial compliance with GCP/ICH and FDA regulations and protocol requirements.
Medical And Technical Research Associates, Inc - Clinical Research Coordinator City, State, 03/1991 - 12/1995
Coordinated all phases of clinical trials from study start-up to study closure.
Coordinated and maintained study documentation including source documents, case report forms, and
regulatory binders.
Served as a liaison between study sponsors and investigative site personnel.
Maintained study database and entered clinical data into tracking system.
Developed data tracking standard operating procedures.
The Children's Hospital - Research Study Coordinator City, State, 01/1987 - 01/1991
Managed a research project under the direction of a physician entitled: "Functional Outcomes and
Behavior Indicators of Sexually Abused Children."
Recruited eligible participants and reviewed medical records to determine study eligibility.
Conducted research interviews with parents and children.
Abstracted data to complete case report forms and administered psychological testing.
Trained and supervised research assistants to perform control group recruitment and research
interviews.
Skills
Auditing, Brochures, clinical trials, database, Database Management, direction, documentation, forms, Functional, GCP, Good Clinical Practice, IND, instruction, Medical Record Review, Medical Terminology, MS Excel, MS Office, Oncology, patient safety, personnel, Project Management, recruitment, research, Reuters, SOP, supervision, surveys
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