Laurie Berkowitz Email & Phone Number

Perform biomarker sample management activities for oncology clinical trials for LabConnect client Takeda.

Remote From Portland, Oregon, Usa

* Co-manage employee COVID-19 screening at 5 locations of client organization, Amgen, in USA and Puerto Rico.* Coordinate with 3rd party staffing firm and laboratory who support the program.* Develop workflows and guidance materials to align with client requirements and changes to requirements.* Train 70 staff working at the testing sites in testing workflows. * Oversee data quality. Develop and manage routine reporting. Train and oversee other staff in reporting and data quality assurance.* Assure data quality for ~3,000 tests per week* Assure inventory of testing supplies per site* Provide ad-hoc special testing support to client for special events and VIPs

Remote From Portland, Oregon

Former titles: Sr. Data Manager. Oversaw team of 6 performing database set-up for digital forms used for tracking clinical research samples. Assisted VP of 40 person department to assure efficient workflows, training and inter-department coordination. Assured sample tracking data quality and database functionality. Participated in development for client-facing custom application including user stories, detailed user requirements, acceptance criteria, testing and coordination with development team.Sample tracking database oversight and system enhancements:* Identified and tracked system enhancement needs and bugs, defined business user and testing requirements, coordinated with on- and off-shore IT to implement. * Oversaw digital form design requirements, ‘building’, mapping, tracking and metrics.* Provided quality oversight for digital form review and sample accessioning.Data Quality Incident Handling - Technical Lead:* Ensured data quality incidents were thoroughly researched. Assisted team members to ensure all compromised data was corrected and preventive measures implemented.Quality:* Monitored data-related processes to identify quality gaps and inefficiencies and worked to improve the related systems, workflows and associated documentation and training.Management/Administration:* Coordinated job descriptions, hiring and training for three position types and managed 6 staff.* Assured workload balancing and metrics management.

Portland, Oregon Area

Data Management* Professional small-scale database design and management* Data cleanup and analysisBusiness Process Improvement* Workflow review, assessment and process documentation* Form design/improvement* Microsoft Office training (Word, Excel, Access and Visio)

Portland, Oregon Area

* Researched and documented operational procedures* Worked with management to clarify operational procedure expectations, simplify procedures and to build in quality control steps to ensure work results meet company expectations* Developed and managed interim process for ensuring accurate billing of client usage of company services while company transitioned to a new accounting system

Portland, Oregon Area

* Conducted clinical database audits* Performed quality reviews of study documentation* Developed process maps and edited/wrote SOPs in conjunction with the development of a new company Quality Management System* Provided support in the conduct of sponsor audits

Portland, Oregon Area

* Internal procedure workflow analysis, standardization and documentation* Developed a departmental SharePoint site* Maintained study binders/documents following Good Clinical Practices (GCP)

Portland, Oregon Area

* Designed, built and maintained an MS Access/SQL database of billing information for over 14,000 medical providers that updated EPIC when OHSU was customizing EPIC for initial implementation.* Communicated with hospital staff when their requests to update provider information could not be processed due to incomplete or incorrect information* Assisted in writing policies related to updating provider information in EPIC* Trained and supervised staff assisting with data validation

Portland, Oregon Area

* Coordinated timely accurate compliance reporting to state and financing agencies on 80+ tax credit properties in 18 states, each with unique reporting requirements* Designed databases to maintain and track tax credit reporting information* Developed automated forms in Excel that calculate the rent and income limits of prospective tenants to assist in accurate and legible data collection. Forms were used by 80+ property managers with limited computer skills* Trained and supervised new employees using company databases and forms

White Salmon, Wa

(1997-1998 the position was as an AmeriCorps volunteer; 1998-1999 the position was on staff)* Developed and implemented various water quality restoration projects in the White Salmon River Watershed* Designed and maintained databases to manage restoration project site data

Trout Lake, Wa

Worked with a 12-person crew doing a variety of community enhancement, educational, and environmental restoration projects in communities throughout the mid-Columbia Gorge