A leader in the clinical research industry in promoting clinical quality systems for sponsors, CROs, technology vendors, and investigation sites, SAM has over 30 years of clinical experience with a MS with a specialization in performance Improvement. She is a subject matter expert in many GCP areas, monitoring, auditing, risk management, vendor oversight, HIPAA, inspection readiness and regulations/guidelines. She authors and presents courses for clinical research pharmaceutical and medical device GCP stakeholders for various functional areas. SAM has led the quality management consulting services for CP with a focus on supporting the synthesis of changing regulations into the client's clinical quality systems while supporting a culture of change. - Management/leadership global experience- CP staff hiring, development and oversight, multiple contractual roles in leadership for clients.- Clinical research services on a contractual basis (Quality Management, Training & Development, Monitoring, Auditing, Process Improvement, Program & Change Facilitation). - Quality management system adaption to promote continuous improvement. - Assist with and/or develop new or revise existing policies, procedures, quality manuals, training programs to meet current industry regulations and industry initiatives, i.e. integration of quality risk management in GCP systems. - Performance Improvement Consultant: analysis of proposed and current organization programs/departments. Conduct performance gap and cause analysis, leading to identifying interventions, implementation and evaluations. - Design, develop, conduct clinical research and soft skills training; audience experience size range experience 1-1500. In-person, online, and eLearning. - Competency based curriculum development and coordination- Client Types: CROs, sponsors, research sites, technology vendors, training organizations, universities.

Training and development for various GCP topics: Risk-BasedMonitoring, Electronic Health Records and Source Documentation, HIPAA HITECH / Omnibus Rulemaking, ISO 14155:2011, many more.

Regulatory lead for CRF Health's electronic consent solution (TRIALCONSENT).

SAM worked within the Medtronic Clinical Research Institute GCO promoting quality standards and training for the monitoring group as the North American trainer. Charged with contributing to MCRI's mission of leveraging globalization, new regulatory change (i.e. Risk-Based Monitoring), economic frugalness with quality and more to support state of the art monitoring services. Responsible for gap analysis of current program, implementation and evaluation of improved standards that include establishing and maintaining training matrix, curriculum, competency testing, evaluation of effectiveness and continuous process improvement.Partner with global service providers (i.e. ACRP) to build and manage the program to promote efficient, compliant, effective and enjoyable performance.SAM continues to work with Medtronic as a training consultant.

Clinical Quality Manager: supporting many functional areas. Development and deployment of site management training curriculum. Later hired as Director of Regional Research: facilitated hiring new regional managers and monitors for a restructured and fast growing device division.

Consulted as a clinical research SME for development and presenting multiple training programs for various Barnett clients (pharma, device sponsors and research sites). Helped develop the training core curriculum for various clients for Monitoring groups. Developed dozens of courses for the web-hosted training line. Presented multiple training courses in person and online.

9 years as a member of the ACRP CCRA exam committee. Served as chair for a portion of the appointment.

Clinical research services provided on a contractual basis including: safety associate, monitoring, coordinating, training, site recruitment, electronic CRF use, site audits and research naive site development.

CRA Field Trainer:➢ Mentor and co-monitor with current CRAs on all study teams.➢ Development, implementation, and performance review of the departmental training➢ Function as a focal point for all clinical training and safety surveillance training➢ Delivers in-house and Field Training➢ Coordinates training on CRO Project Tracking and Report Writing Oracle System➢ Oversees the Training of New clinical employees➢ Evaluates on-site performance of CRAs➢ Monitored Phase II, III and IVSr.CRA: ➢ Project specific field instruction, in-services and mentoring for CRA trainees➢ Review of monitoring visit reports➢ Literature review for potential studies➢ Cross-monitoring multiple studies➢ Assisting project management in protocol-specific tasks➢ Participate in the conduct of multi-center clinical research studies➢ Review of project related materials and literature to develop a basic understanding of protocol and therapeutic areas➢ Participates and presents at investigator meetings for assigned studies.➢ Assist in investigator recruitment➢ Site Management: Evaluates, initiates, monitors and closes out sites according to applicable SOPs and FDA guidelines➢ Review Case Report Forms for completeness, clarity, legibility, conformity to available source documents and adherence to protocol requirements➢ Query resolution: Resolves Case Report Form discrepancies and/or clarifications via site visits➢ Verifying completeness of critical documents and report adverse events➢ Perform sponsor master file and investigator file audits➢ Phase II, III and IV trials

➢ Participates in the conduct of multi-center clinical research studies➢ Review project related materials and literature to develop a basic understanding of protocol and therapeutic areas➢ Participate and presents at investigator meetings for assigned studies➢ Assists in investigator recruitment➢ Site Management: Evaluates, initiates, monitors and closes out sites according to applicable SOPs and FDA guidelines➢ Review Case Report Forms for completeness, clarity, legibility, conformity to available source documents and adherence to protocol requirements➢ Query resolution: Resolves Case Report Form discrepancies and/or clarifications via site visits➢ Perform drug accountability at site visits➢ Verify completeness of critical documents and report adverse events➢ Perform sponsor master file and investigator file audits➢ Phase III trials