Sarah Shern

Experience

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  Wausau Insurance

  May 2004 - Oct 2005

  Case Manager
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  PRA International

  Oct 2005 - Jun 2007

  Clinical Operations Specalist

  • Performs Investigator Evaluation and Recruitment• Performs Essential Document Collection, Review, and Maintenance and Close Out activities• Performs Study Tracking to ensure that the study files are current, accurate, and complete• Liaises With Internal and External Customer to meet project specific goals• Supports Lead CRA/Clinical Team Lead/LCOS/CRA in the management of investigational sites to ensure compliance with the trial protocol, ICH-GCP and applicable regulations• Supports Lead CRA/Clinical Team Lead/LCOS to resolve internal and external clinical issues for client research projects managed by PRA• Supports Lead CRA/Clinical Team/LCOS/CRA in management of clinical budget and evaluation of study processes.• Conduct co-monitoring visits as requested by the Lead CRA Show less

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  Quintiles

  Jun 2007 - Mar 2016

  • Manage a caseload of visit report reviews for assigned studies, ensuring compliance to the protocol, processes, timelines, Quintiles/applicable SOPs, and GCP guidelines.• Review assigned visit reports in order to ensure all site issues are adequately documented, reported and followed up to resolution, as well as, assuring a high quality of SVRs.• Provide guidance to the CPM at project start-up and throughout the study, in development of visit report annotations, guidelines, and assure efficient completion of visit reports by the CRAs:o Assist CPMs in the utilization of the standard annotations to limit unnecessary customization.o Collaborate with CPMs on training of SVR annotations, completion and submission per SOP.• Identify and track the project team compliance to SOPs for submission and approval of the visit report through direct communication with the CRA and/or if necessary their Line Manager.• Prepare and escalate issues noted in the site visit report which could impact subject safety, regulatory compliance and/or data integrity to the CPMs and CRA LM and/or Clinical Site Monitoring Quality Manager (CSiMQM), as necessary.• Review the visit reports to ensure identification and implementation of findings or focused site visit observations requiring corrective and /or preventative action plans.• Attend regular teleconferences with CPMs to discuss any SVR review issues illustrative of quality/performance deficiencies across PIs/sites and CRAs in a given project. Assist the CPMs with review of the trends emerging from the Issue Escalation Log.• Partner with the project team members to decrease the level of corrections/additions needed on reports by providing ongoing mentoring, coaching and better understanding of the SVR annotations.• Provide additional team SVR support through other activities such as quality checks, data trending, providing back up support and mentoring and coaching of junior SRSs. Show less • Collect, track and review study site critical documents used to monitor interest for enrollment of investigative sites.• Ensure compliance with protocol guidelines and requirements of regulatory agencies, including the provisions of the Anti-Kickback Statute (USA) and the False Claims Act (USA).• Work with Project Coordination Center (PCC) Lead to provide guidance on study protocol for study site personnel; if applicable, schedule and conduct teleconference training sessions for study site personnel.• Assist the PCC Lead with the development of project specific scripts, and completion/analysis of data collected from investigator sites, with the Clinical Management Plan (CMP), the Site Management Plan (SMP), and other related documents/agreements for assigned projects.• Manage the work of various principal investigator (PI) site(s) with minimal lead oversight. Establish and monitor site specific patient recruitment plans with assigned study sites.• Ensure established guidelines in the collection and tracking of clinical data and resolution of data queries are followed, evaluate and assure quality of data collected; ensure that all data and study documents are handled consistently with study plans and client preferences and with the demands of regulatory agencies with respect to data protection.• Identify problems and/or inconsistencies; monitor site and subject progress, including documentation and reporting of adverse events; recommend corrective actions as appropriate; escalate to PCC Lead or line manager• Respond to questions or escalated questions on study procedures/protocol via the study hotline.• Liaise and work in conjunction with CRAs monitoring on-site as needed. Serve as a mentor to PCC Clinical Assistant staff and iCRA’s. Provide training on procedures as needed. Show less • Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.• Manage 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.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.• Act as a mentor for clinical staff including conducting co-monitoring and training visits.• May provide assistance to the CTL with design of study tools, documents and processes. Show less • Assist Clinical Team Lead(CTL)/CRA with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines• Collaborate with CTL on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures• Manage and perform quality control audits on trial master file and investigator site files • Assist with the tracking and management of Case Report Forms, queries, and clinical data flow• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation• Participate in sponsor and project team meetings providing study status updates • Accompany CRAs on site visits to assist with clinical monitoring duties Show less

  • Associate Site Report Specialist/ Clinical Research Specialist

    Apr 2012 - Mar 2016

  • Senior In-House Clinical Research Associate

    Aug 2011 - Apr 2012

  • Senior Clinical Research Associate

    Jun 2008 - Aug 2011

  • Senior Clinical Trials Assistant

    Jun 2007 - Jun 2008
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  ICON plc

  Mar 2016 - now

  DMC Project Manager, IDEA