Christina Lafferty Email and Phone Number

Helping to address global public health challenges.

Responsible and accountable for the management of the Clinical Operations team with particular emphasis on teamwork, quality, timelines, budget, metrics and compliance with the project plans and SOPs.Develop the strategy, plans, tools and training to oversee and assess performance of the clinical team, in the conduct and compliance of site visits (on site and remote), including, but not limited to: Pre-Study Visits, Site Initiation Visits, Routine Monitoring Visit, Motivational Visits, Close-out Visits, Audit support Visits.Proactively communicate with CRAs and other members of the clinical operations team to follow up on all open issues, drive patient recruitment and retention, in order to meet the project timelines.Ensure that all study related, clinical related documents are tracked, filed and reviewed (QC check) and complete according to the SOPs, regulatory requirements and protocol.Responsible and accountable for understanding and managing the clinical operations budget for the project, and ensuring that the activities are within budget and scope of work, and to discuss with the project team to support financial progress, and team utilization.Communicate effectively with all members of the project team and client as applicable, to support the study completion per company and client requirements and timelines, including risk identification and mitigation, issue escalation and working with Quality and the project team on Corrective and Preventative Actions.Participate and oversee the site selection process, the regulatory/ethics committee submissions, tracking and documentation.Support new business with active participation in Bid Defense preparation and meetings, as required.Perform other duties as required by the Department or Project Team.

Collaborates with the central study team for final selection of sites to participate in the trial.Ensured local/country team is meeting requirement targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents, and applicable regulations. This can require development of local trial specific procedures and tools, recruitment planning, contingency and risk management.Acted as a primary company contact for assigned trial at the country level, attended/participated in Investigator Meetings as needed.Drived study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. When necessary, initiated corrective and preventative actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams.Contributed to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research targets.Delivered competent vendor management at the country level to support the study and submit requests for vendor services and support vendor selection. This included reviewing and approving site and local vendor invoices as required. As required, managed the local study supply.Ensured high standards for study monitoring by conducting quality local trial team meetings and facilitating SM training, when needed (i.e. implementation of study amendment and changes in study related processes).Contributed to patient understanding of protocol and patient safety by preparing country specific informed consent in accordance with procedural documents/templates. This included reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.

Performed investigator recruitment activities utilizing phone, scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites.Utilized the Clinical Trial Management System (CTMS) to ensure investigator recruitment activities are accurately tracked.Performed essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory and Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements.Performed study tracking via CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete.Documented site and Sponsor contact and study interactions in a timely and professional manner.Assisted with resolution of investigational site/data queries.Liaises with project team members regarding study site issues.Provided quality review of the informed consents including direct contact with sites on negotiation of language Performed study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other requirements stipulated in the study.Followed up with sites for trial invoices and ensures CTMS is accurately updated to allow the timely processing of Investigator Payments.Performed other duties as assigned.Member of Emergency Response Team Conducted interviews of potential new hires

Tracked and analyzed project details and maintained internal systems for assigned projects within a therapeutic area.Assured compliance with local regulations, Code of Federal Regulations/International Conference of Harmonization (ICH), Good Clinical Practices (GCP) guidelines, and Company and Sponsor Standard Operating Procedures (SOPs) Kept Project Leadership and Clinical Research Associates (CRAs) fully apprised of sites and study status. Recorded the status of Key Performance Indicators (KPIs) in assigned systems. Assess and communicate KPIs for associated job tasks to the PM with a proposed action plan. Prepared and provide status reports to customers Assisted in planning and was a presenter at Investigator meetingOversees regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. Global Project Specialist managing PS’s in all regions including development of PS metricsVendor Management including authorizing IP release Interviewed potential new hire Project SpecialistsProvided quality review of the Confidentiality Agreement

Assisted PM and Clinical Research Manager in preparing project status reports for the sponsor.Responsible for documenting, finalizing and distributing all project team and sponsor agenda and meeting minutes.Supported PM, Clinical Research manager and CRA’s throughout the length of study.Interviewed potential new hire Project AssistantsAssisted with training of new Project Assistants in addition to mentoring.Assisted in the preparation for Kick off and Investigator meetings.Provided sponsor training on PRIMA GatewayPrepared IP-Release for new site locationsExperienced in startup and closeout activities for clinical trialsReviewed regulatory documents received from sites for accuracyCoordinated IRB submissions