Sharon Warren Email & Phone Number

Burlington, North Carolina, US

Responsible for management of Clinical Operations team with emphasis on teamwork, quality, budget, metrics and compliance with the project plans and SOPs. Develop plans, tools and training to oversee and assess performance of the clinical team. Responsible for managing the Clinical Operations budget for the project and ensure that the activities are within.

Durham, NC, US

• Provide oversight regarding site management and monitoring via oversight of CROs to ensure study deliverables and timelines are met.
• Proactively manage recruitment, compliance and quality issues at investigational sites.
• Review, reconcile and remote monitor subject data in electronic Case Report Forms and vendor systems in real time for completeness and accuracy.
• Monitor subject compliance with patient-entered electronic clinical outcome assessment devices.
• Ensure adequate supplies are maintained at sites to support screening and study execution.
• Ensure monitoring visits are scheduled and reports submitted and finalized within the clinical monitoring plan.

Thousand Oaks, CA, US

• Collaborating with functional team members to drive study deliverables such as enrollment, data quality, and ICH GCP compliance
• Manage process for planning and procuring ancillary clinical supplies
• Facilitate and collate country recruitment plans
• Create and manage study specific tools such as recruitment and retention materials and study newsletters
• Responsible for reconciling data for Primary Analysis and presenting comprehensive conclusions.
• Review subject data and comment on findings within eLog

Durham, North Carolina, US

• Conduct general site contacts in accordance to the study specific Monitoring Plan, which may include:o Review recruitment plan and enrollment updateso Collaborate with CRA; address/resolve issues pending from the.
• Follow up on data entry, query status and Serious Adverse Events (SAEs)
• Generate contact reports in accordance with departmental timelines
• Conduct remote visits (initiation, monitoring, termination)
• Perform regular reviews of site level data (e.g. Clinical Trial Management System (CTMS), Trial Management System (TMS), EDC, Interactive Voice Response System) and ensure timely and high quality data entry compliance.
• Train site team members on study specific tasks

Leopardstown, Dublin, IE

Durham, North Carolina, US

• Collected, tracked and reviewed study site critical documents used to monitor interest for enrollment of investigative sites.
• Ensured compliance with protocol guidelines and requirements of regulatory agencies.
• Assisted the Project Coordination Center (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.
• Thoroughly documented and tracked all communication (e-mail, voice, fax, call reports) with all study site personnel and any client interaction
• Managed the work of various principal investigator (PI) site(s) with minimal lead oversight. Established and monitored site specific patient recruitment plans with assigned study sites.
• Ensured established guidelines in the collection and tracking of clinical data and resolution of data queries were followed, evaluated and assured quality of data collected.

Durham, North Carolina, US

• Collected, tracked and reviewed study site critical documents used to monitor interest for enrollment of investigative sites.
• Ensured compliance with protocol guidelines and requirements of regulatory agencies.
• Thoroughly documented and tracked all communication (e-mail, voice, fax, call reports) with all study site personnel and any client interaction in accordance with study plans.
• Assisted in the development of site specific recruitment, retention and follow-up plans/processes in line with the project strategy provided by Project Coordination Centre (PCC) Lead. Ensured the site were recording.
• Followed established guidelines in the collection and tracking of clinical data and resolution of data queries in accordance with study plans and client preferences. Evaluate and assure quality of data collected.
• Identified problems and/or inconsistencies, monitored site and subject progress, including documentation and reporting of adverse events; recommended corrective action as appropriate, escalated to PCC Lead or line.

US

 Conducted Site Initiation Visits, Interim Monitoring and Closeout Visits to determine protocol and regulatory compliance. Co-monitored with CRO assigned to study to ensure sites were compliant with protocol and study guidelines. Prepared site visit reports and follow-up letters to accurately identify site activities and actions requiring follow-up..

Research Triangle Park, NC, US

 Co-monitored for local sites to ensure compliance with protocol and study specific guidelines. Assisted with expedited identification, retrieval and review of study documents, particularly those required for site activation/study startup. Reviewed site visit trip reports (PSV, SIV, IMV and COV) for accuracy and requested clarification of discrepant.

US

 Site Management: Managed study process to ensure adherence to protocol, Standard Operating Procedures (SOPs), GCP/ICH Guidelines, applicable regulatory requirements and other documentation requirements. Conducted Site Initiation Visits and Closeout Visits via webex. Co-monitored for Phase II and Phase III studies for local sites to ensure compliance.

Foster City, CA, US

 Assisted in document collection and tracking for study start-up activities. Setup and maintenance of study database through Siebel eClinical CTMS system. Creation and management of study specific timelines utilizing GANTT charts. Created and implemented tracking systems to document study progress. Assisted with investigator meeting planning to.

Foster City, CA, US

 Received and reviewed routine adverse event forms for completeness and performed initial data entry into safety database. Contacted sites to obtain follow-up information on SAEs and pregnancy outcomes. Generated lab reports for initial and follow-up SAEs. Maintained Safety mailbox and routed incoming individual case safety reports (ICSRs). Generated.