Alex Nelson Email & Phone Number

Seattle, Washington, United States

Manage multiple clinical trials staged in multiple testing facilities across the United states for the laboratory’s Specialty Clinical Trials (SCT) business unit. Lead briefings for clinical sites, detailing study criteria, demographics, and study specifics. Manage studies that range from 180 days to 60 months with budgets of up to $1.3M.• Collaborate with clients to design and execute scope, budget, and timelines of clinical trials based on contractually stipulated guidelines and requirements.• Improve study protocols and SOPs through the redesign and introduction of new patient sample tracking procedures, including revenue tracking as compared to the revenue goal of $10M.• Execute studies, product testing, and data analysis completion within stringent timelines, while concurrently managing other studies and developing accurate product insights.• Plan and provide group and 1:1 onboarding and training to new employees in the Seattle laboratory.• Serve as key point of contact for clients, many of whom participate in multiple projects simultaneously.• Ensure that all studies were following clinical trial guidelines (GCLP, CAP/CLIA, FDA)

Greater Seattle Area

Drove all stages of concurrent cancer-related studies, from design, scheduling, and implementation through to maintenance and conclusion, using iterative and waterfall methodologies. Managed collaborations with internal and external (on/offshore) teams, including partners at the federal level. Oversaw adherence to quality standards set by governing bodies (FDA and NIH). Directed setup, testing, and custom programming support for studies, created reports for clinical data and project metrics, and updated documentation /practices for standard operating procedures (SOPs).• Completed the most maintenance on clinical studies of all Project Specialists in the Applications Development group for five (5) years in a row. In 2021, delivered 63 revisions across 25 active cancer studies, 47 on studies overseen by the FDA and requiring significantly more documentation and attention to detail.• Reduced average number of bugs found in testing per eCRF designed by .05 (.5 to .45) from 2020 to 2021, lowest in the department for each year.• Selected to oversee maintenance for 76% of SWOG’s (National Cancer Institute-supported organization conducting clinical trials) FDA studies due to higher level of experience and status as longer-tenured member of department. - Built tables in separate database with different external oversight from the FDA. - Manage change to studies that need separate validation paperwork requiring internal and external approval before it can be released to production. • Promoted to Project Specialist II level in under 24 months; trained six (6) new hires and oversaw management of most clinical trials for five (5) straight years. Received outstanding performance appraisals in annual reviews.

Greater Seattle Area

Conducted and oversaw laboratory testing and analysis including PCR, SNP, genotyping, DNA sequencing, mass spectrometry, and DNA extraction/isolation. Ensured adherence with safety and regulatory guidelines. Delivered training to less-experienced technologists on lab procedures and practices.• Chosen as sole tech assigned to non-standard sample testing which entailed processing samples beyond the standard mouth swabs sent (e.g., toothbrushes, hair, tissues), work that required a higher level of precision.• Tapped to draft, maintain, and update SOP documents as company grew and more techs were hired.