TAMYKA LASSITER

• Effectively managed 21 sites, across 3 protocols
• Assisted the Clinical Operations team in the execution of clinical trial deliverables, and development of study plans, work instructions and guidelines
• Conducted site feasibility assessments, participated in the site identification and selection process, and analyzed patient recruitment and retention rates
• Functioned as the primary point of contact with sites, including traveling to, managing, and monitoring them, by performing Site Initiation Visits and training activities, Periodic Monitoring Visits, and Closeout Visits
• Performed souce data verification within electronic data capture systems
• Identified, reviewed, and managed Adverse Events/Serious Adverse Events, other unanticipated events, protocol deviations, and reporting them in the appropriate study systems and to required stakeholders
• Managed project risk by identifying, quantifying and monitoring potential threats.
• Followed drug storage procedures, and accountability, to comply with protocols and SOP requirements.
• Organized and monitored investigator study files, within paper and/or electronic document management systems (eTMF, eRegulatory portals, etc.), to assist with site inspection readiness efforts
• Maintained knowledge of company strategic direction, goals and objectives and aligned site activities appropriately
• Maintained working knowledge of ICH/GCP Guidelines, other applicable guidance, relevant regulations, and company SOPs/processes
• Trained and mentored new staff, when needed, on the study protocol, study vendors/processes and operating procedures

NOTE: Company decision to layoff Clinical Operations department, due to financial/business matters

• Conducted all aspects of study site monitoring and management, including conduct of pre-study and initiation visits, monitoring and close-out of clinical sites, and maintenance of study files, as prescribed in project plans
• Created and maintained site recruitment and retention plans, over the life of assigned studies, achieving agreed upon recruitment goals
• Independently performed CRF review, and query generation and resolution, against established data review guidelines
• Prepared accurate and timely trip reports
• Completed process of Serious Adverse Event (SAE) reporting and follow up
• Adhered to Sponsor metrics related to monitoring visit timelines, trip report submission, data verification, and query resolution
• Reviewed progress of projects, and initiated appropriate actions to achieve target objectives, by interacting with internal work groups to evaluate needs, resources and timelines
• Participated in the Sponsor's mentoring program, assisting new hires with achieving requirements, to perform independent monitoring, within the required timelines
• Conducted, reported on and followed up on Quality Control Visits, when requested

• Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion
• Monitored sites, to ensure studies are performed according to the protocol, company SOPs, applicable regulations, and principles of ICH-GCP
• Provided staff training and monitoring competence to inexperienced/less experienced colleagues.

• Performed site qualification, initiation, interim and close-out visits, ensuring regulatory and protocol compliance for up to 10 studies simultaneously
• Utilized risk-based monitoring, while performing on-site or remote visits, with monitoring intervals dependent upon site enrollment, site issues/risk, and data review needs
• Managed site-level activities to establish project objectives, expectations, deliverables, and timelines, and ensuring they were met
• Evaluated execution of study protocol at site-level to determine overall performance of site and site staff
• Provided recommendations regarding site-specific actions, and escalated serious issues to project teams, which included corrective action plans (CAPs) and audit responses

• Provided site management for a variety of protocols, sites and therapeutic areas for Global Functional Resourcing and Clinical Site Management
• Administered protocol and related study training to assigned sites and established regular lines of communication with sites to manage ongoing project expectations and issues
• Evaluated quality and integrity of study site practices related to protocol and adherence to applicable regulations
• Escalated quality issues to Clinical Project Manager (CPM), Clinical Research Specialist (CRS), and Line Manager
• Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
• Lead a CRA team to assist sites with new data entry requirements, and resolving data issues, in anticipation of database lock.
• Mentored and trained less experienced staff, including performing assessment visits to identify areas of improvement, and providing feedback to line and project management

• Supervised a team of CRAs, which included managing day-to-day monitoring activities for assigned trials, and acted as the primary point of contact for the monitoring team
• Ensured appropriate allocation of CRA resources and determined site assignments
• Conducted regularly scheduled CRA team teleconferences and protocol training
• Developed monitoring plans, study binders, study guidelines, study management and tracking tools and trip reports
• Reviewed trip reports and provided feedback, per project plans, study guidelines, and SOPs
• Coordinated materials and instructions for on-site study staff based on protocol, SOPs, and established guidelines
• Liaised with vendors to develop and execute scope of work and project plans
• Lead a team to help mitigate issues related to cardiovascular events adjudication
• Reviewed study progress and escalated issues reported by the CRA team
• Monitored an assigned site, ensuring inspection readiness
• Conducted co-monitoring visits when needed for non-compliant sites and CRA training.
• Trained, mentored, and developed new and junior employees

• Promoted from Senior Clinical Research Associate role to manage, lead, motivate, and support assigned project Clinical Research Associates and assume financial responsibility for allocated projects
• Communicated with Sponsors, third party vendors, and internal departments to carry out project activities
• Coordinated and attended study meetings (i.e
• Project team trainings/teleconferences)
• Reviewed and approved monitoring reports and assisted with maintenance of tracking reports and listings.

• Senior Clinical Research Associate at Theorem Clinical Research, 2005-2008
• Regional Clinical Research Associate at Scirex Corporation, 2002-2005
• Clinical Application Specialist at Araccel Corporation, 2001-2002
• Clinical Research Associate at Quintiles Inc., 2000-2001
• Clinical Research Assistant at Quintiles Inc., 1999-2000
• Operating Room Staff Nurse at Duke University Medical Center, 1997-1999