Over 20 years clinical research experience in medical device and pharmaceutical studies.
*Proficient in Feasibility (animal and human studies) through Marketing studies in medical device.
*Experienced in Phase I through Phase IV pharmaceutical studies.
*Exceptional knowledge of GCP, GMP, GLP, ICH, FDA 21 CFR, ISO 14155:2011, ISO 80601-2-61:2011 MDD 93/42/EEC.
*Experienced and proficient in site/investigator qualification, study/site initiation, monitoring, and closeout visits.
*Experienced and proficient in writing protocols, informed consents, clinical study reports, and PMA/IDE annual reports.
*Managed clinical projects in life support systems - respiratory/anesthesia and cardiovascular systems; diagnostic imaging (Molecular Imaging and Computed Tomography); ophthalmology; hypercholesterolemia; breast cancer; migraine; septic shock; euvolemic hyponatremia; hyponatremia on subjects with CHF; analgesia study on subjects that undergone total knee arthroplasty; cardiovascular surgery; and electrophysiology.
*Dependable, self-motivated, self-reliant, meticulous, organized, and detail oriented.
*Exceptional verbal and written communication.
*Ability to work as a strong individual contributor within a team environment across multiple business segments and cross functional teams.
*A quick learner with strong, diverse product knowledge and able to function as a subject matter expert.
California State Polytechnic UniversityMarch 1997Bachelor of Science Degree: Foods and NutritionStateFoods and Nutrition
Mount San Antonio CollegeJune 1985Associate Arts Degree: Computer ScienceComputer Science
2016FDA BIMO Compliance and Enforcement of Drugs and Device
2016- Diverse Women in Clinical Trials Webinar Series - Part I: Planning for Diversity
2016- Diverse Women in Clinical Trials Webinar Series - Part II: Recruitment & Retention
2015- Presenting with Impact and Clarity
2015- Thriving in a Matrixed Organization
2014- Effective Protocol Design-Quality Risk Management
2013- Clinical Quality Assurance (FDA)
2012- Project Management at GE
2012- Project Leadership Course
2011Medical Writer Certificate-AMWA [Oct-2011]
2011 - Influencing Skills at GE
2011- CAP Coaches Workshop
2011- GEHC MACA Leadership Skills
2010- Intro to Life Support Solutions Products
2010- Phase Forward InForm (CRA, CRC, PI)
2010- IMPACT and IMPACT/Mysites
2010- ICH E6 - Good Clinical Practices (review)
2006- Project ManagementAdvanced Echocardiography
2001- OCRA, Conducting Successful Clinical Trials under GCP Regulations
2001- Association of Clinical Research Professionals Annual Meeting
2001- Writing courses thru American Medical Writers Association for Certification
2001- Conducting Successful Clinical Trials under GCP Regulations to Facilitate the Product Approval Process
2000- Comprehensive Review of Intraoperative Echo & Transesophageal Echo
2000- Comprehensive Monitoring through Barnett International
1999- Heart Valve Therapy Clinical Research Training
1999- Transmyocardial Revascularization (TMR) Training
1999- Comprehensive Monitoring
1999- Good Documentation Practices under GP1012
1997- Good Clinical Practices
1997- Electrophysiology Training
Johnson, A.; Lauer, C.K.; Cadogan, C. (2016) "How Did You Get Here? Stories of Bench Research, Bollywood, and Stormy Epiphanies." AMWA Journal. 31(3):118-119
PRESENTATION:
Presenter, "Transitioning Intro Medical Writing for Diverse Professionals," AMWA's 75th Annual Conference: Quest toward Brilliance, September 30-October 3, 2015, San Antonio, TX
Presenter, "From R&D to Clinical Trials: Medical Writing Strategies for Global Teams," AMWA's 74th Annual Conference: Shake, Rattle, and RollWrite, October 8-11, 2014, Memphis, TN