Jessica Masarek

Quality assurance consultant providing subject matter expertise and services in the following areas: • Clinical audits for investigator sites, vendors, regulatory submissions, and internal processes • Full service quality assurance consulting, team support, and auditor training • Trial master file system and process development, implementation, and remediation • Risk management and implementation of risk-based approaches within quality and clinical operations • Regulatory inspection support, facilitation, and response assistance

• Initiated and supported continuous improvement, special projects and compliance initiatives for US Clinical Operations • Managed audit review for US Clinical Operations, including review and assessment of US site audit reports, identification of compliance trends, proposal/implementation of CAPAs and stakeholder training • Process Lead role for global Trial Master File initiative: supported development of system to manage regulatory documentation in support of clinical trials. Identified process needs with key stakeholders, developed and implemented process for system launch in November 2011. Identified process and technology risks, implemented process changes, documentation and user support needs. • Drove development and implementation of SOPs, local processes and training • Root cause analysis, assessment of compliance issues and development of risk mitigation plans as part of deviation management.

• Lead high volume of investigator site, vendor, regulatory submission and system audits. • Quality Lead for neuroscience, cardiovascular and oncology products, providing subject matter expertise in CFR, GCP and SOP interpretation, risk identification, management of mitigation activities, and identification of continuous improvement. • Management of compliance cases under suspected significant deviations process, including establishment of review team, eliciting case information, root cause analysis and CAPA development. • Development, writing and editing of departmental and corporate guidance documents

• Managed and developed a small team of quality assurance staff • Facilitated and responded to inspections/audits • Implemented CAPA management and improved the quality of services and compliance across departments • Performed and managed internal system, investigator site and vendor audits • Worked with multiple departments to facilitate the establishment of and adherence to training programs and internal process improvements • Provided GCP, inspection readiness and QA training, internally and to investigator sites • Developed and managed quality system documentation, including extensive SOP writing. • Validated CRF systems, including software, hardware and databases (local and EDC)

• System validation, including requirements development, authoring and execution of test scripts • Key involvement in development of CTMS for imaging core lab • In-house monitoring of imaging data and site interaction • Quality control and analysis of oncology medical imaging data • Project-related technical writing • Data management and study close-out activities for global studies

As part of a partnership between The United Way and Americorps, worked with a portfolio of 30+ nonprofit organizations on technology based projects, helping them to thrive in an increasingly technology-driven environment.