Clinical Research Associate

• Jun 2022 - Present

Board Member - Expedited Review

• May 2015 - May 2022

IRB (Institutional Review Board) Board Member Review and Approval of Human Subjects Research using knowledge of federal and local regulations IRB (Institutional Review Board) Board Member Review and Approval of Human Subjects Research using knowledge of federal and local regulations

Clinical Research Coordinator

• Jul 2012 - May 2015

Managed clinical research trials in a small office. Responsibilities included: •Protocol review. •Accurate completion and documentation of protocol specified procedures. •Developing study visit source documentation for efficient and reliable data collection records •Direct patient care. •Informed consent of subjects. •Assessment and documentation of current and past medical conditions. •Procedure documentation. •Phlebotomy, lab processing and shipping. •Patient training and education. •Review of records and medical history to assess potential trial eligibility. •Collecting, maintaining and submitting documentation of subject data to trial sponsors. •Working with the trial sponsors for quality assurance of data submitted. •Working with site staff including investigators to ensure work is completed in a timely manner. •Working with regulatory authorities to insure subject safety. •Work following ICH-GCP and HIPPA guidelines. •Established a new clinical trial office and all required technology/facilities to provide service to a number of principle investigators in the Puyallup area. •Relocated the Puyallup office when employer’s space management department reallocated office space. Show less

Clinical Research Coordinator

• Oct 2002 - Jun 2012

Manage clinical research trials in a small office. Responsibilities include : • budget and contract review and negotiation, • direct patient care, • informed consent of subjects • assessment and documentation of current and past medical conditions, • procedure documentation, • phlebotomy, IV start and management, lab processing and shipping, • patient training and education, • protocol review and accurate completion and documentation of protocol procedures, • developing study visit source documentation for efficient and reliable data collection records, • review of records and medical history to determine trial eligibility, • collecting, maintaining and submitting documentation of subject data to trial sponsors, • working with the trial sponsors for quality assurance of data submitted, • working with site staff including investigators to ensure work is completed in a timely manner, • working with regulatory authorities to insure subject safety • work following ICH-GCP and HIPPA guidelines. Show less

Orthopedic Assistant

• Jun 1998 - Oct 2002

Assist orthopedist in clinic by: • rooming patients and taking medical histories, • direct patient care including measuring vital signs, ordering x-rays, removing stitches, wound care, casting fractures, • clinic administrative work including scheduling appointments, pre-operative appointment administrative documentation including surgical consent, getting insurance authorizations, calling in prescriptions, scheduling diagnostic testing, maintaining patients' medical records, • patient education on injury or post-surgical rehabilitation, • coordinating research studies, Show less

Certified Athletic Trainer

• Aug 1988 - Jun 1998

Responsibilities included the prevention, immediate care and rehabilitation of athletic injuries and sudden illness as well as the education of coaches and athletes on those subjects. Adjunct responsibilities included: • the training room facility budget, ordering and maintaining supplies; • recruiting student athletic trainers, training them and overseeing their work; • developing school-wide policies and procedures for both emergency management and bloodborne pathogen infection control and conducting related staff training. Show less