Independent Advisory Support (Part-Time) - Sound Medical Research (SMO) - Port Orchard, WA
(2026-03)
- Provided hands-on support to a former employer during a full-time job search, drawing on prior Director-level knowledge of site operations, SOPs, and sponsor/CRO/IRB requirements.
- Modernized SOPs and site-level processes to improve competitiveness for future study selection, including completion of study feasibility questionnaires.
- Delivered site staff training to help sustain GCP-compliant operations during a period of reduced trial volume.
Senior Clinical Research Associate - PPD (Thermo Fisher Scientific) - Seattle, WA
(2023-01 - 2026-01)
- Sustained full compliance across 5–8 concurrent investigator sites in infectious disease, ESKD, and obesity trials, spanning national/regional Western US territories, by independently managing site qualification through closeout visit cycles.
- Closed critical coverage gaps as SWAT CRA, preventing timeline slippage on multi-site protocols, by performing co-monitoring and flexible cross-portfolio support.
- Met sponsor-required corrective action timelines on every assigned site, as measured by zero missed CAPA deadlines, by auditing SDV, informed consent, and AE documentation and issuing monitoring reports on schedule.
- Resolved cross-functional site issues in partnership with data management, medical monitors, and PMs by leading quality-improvement initiatives at the site level.
Clinical Research Associate - PPD (Thermo Fisher Scientific) - Seattle, WA
(2020-08 - 2023-01)
- Continued critical trial oversight through the COVID-19 pandemic by conducting onsite interim monitoring visits at hospitals actively treating COVID-19 patients, including a critical-care infectious disease trial, ensuring uninterrupted data integrity and patient safety when many CRAs shifted to remote-only monitoring.
- Delivered ICH-GCP and 21 CFR Part 50/56/312-compliant monitoring across 7 Phase II–IV trials in infectious disease, renal, and obesity by executing full site-initiation-through-closeout visit cycles, sustaining 60–80% travel across assigned territories.
- Improved site data quality and enrollment performance by delivering hands-on CRF/source document training to site personnel.
Director of Clinical Research - Sound Medical Research (SMO) - Port Orchard, WA
(2016-01 - 2020-12)
- Formalized into the Director role as leadership validated a gradual transition from a bridging position, as measured by the company's decision to eliminate the standalone Clinical Trials Manager role and consolidate it into this position, reflecting confidence in the expanded scope already being carried.
- Delivered 35+ Phase II–IV clinical trials across cardiovascular, diabetes, and renal disease with an exemplary regulatory inspection record, as measured by zero critical findings across tenure, by leading a 7–10 person research operations team.
- Grew the SMO's competitive trial portfolio by owning sponsor relationship management, contract negotiation, and feasibility assessments across government, hybrid, and industry-sponsored studies.
- Standardized site-wide GCP compliance by authoring and rolling out SOPs, QA processes, and staff training curricula.
Clinical Trials Manager / Clinical Research Coordinator (Bridging Role) - Sound Medical Research (SMO) - Port Orchard, WA
(2015-01 - 2016-01)
- Selected to backfill two departing leaders' responsibilities in successive years while still holding a coordinator-level title, as measured by zero disruption to active trial timelines, by absorbing part-time Clinical Trials Manager duties for an outgoing CTM transitioning to part-time status.
- Progressively assumed full Director-level responsibility as the incumbent Director semi-retired, as measured by a seamless leadership transition with no lapse in sponsor or site oversight, by incrementally taking on strategic and operational duties beyond the coordinator scope.
- Coordinated cardiovascular, diabetes, and renal disease trials end-to-end during the transition period by managing patient recruitment, screening, informed consent, and source documentation alongside the expanding managerial scope.
Clinical Research Coordinator - Sound Medical Research (SMO) - Port Orchard, WA
(2011-01 - 2012-12)
- Coordinated multiple Phase II–IV clinical trials in cardiovascular, diabetes, and renal disease, managing all aspects of patient recruitment, screening, enrollment, and retention.
- Obtained informed consent, collected clinical data, performed protocol-specified procedures, and maintained accurate source documentation in compliance with GCP and regulatory requirements.
- Served as primary liaison between study participants, principal investigators, and sponsor monitors to ensure optimal study conduct and participant safety.
- Managed regulatory submissions, adverse event reporting, query resolution, and preparation for monitoring visits and regulatory inspections.
