Liz Dean Email & Phone Number

Homebased

Homebased

Home-Based, San Diego, Ca

• Conduct the remote clinical monitoring in accordance with State and Federal Regulations, Good Clinical Practices and Standard Operating Procedures for a phase III 3 study of an investigational product for COPD• Perform remote clinical monitoring activities (issue resolution, patient enrollment management, drug supply management, and ensuring timely data entry at a site level)• Management of protocol, informed consent, and contract amendments• Create and distribute study document (e.g. eSignature Agreement, Amendments, etc.)• Responsible for the completeness and quality of the in-house site specific files • Update all relevant tracking system on an ongoing basis, including the maintenance of site staff details• Perform regular reviews of data according to data review/monitoring guidelines (CTMS, EDC, IVRS, ISIS)• Conduct remote visits (initiation, monitoring, termination)• Serve as primary site support by conducting outbound and receiving inbound calls from study sties to: - Review recruitment plan and enrollment updates - Address/resolve issues pending from the previous visit - Check on site staff assignment - Assess drug/study supply status - Request outstanding documents - Review site payment status - Follow-up on data entry, query status and SAEs - Follow-up on appropriate site related questions• Build relationships with investigators and site staff• Collaborate with study team on a daily basis to ensure resolution of and outstanding issues

San Diego, Ca

• Monitor multiple investigational sites in accordance with State and Federal Regulations, Good Clinical Practices and Standard Operating Procedures for a phase III 3 study of an investigational product for Goucher’s Disease.• Independently schedule and prioritize workload to meet project deadlines for 3 protocols at one time.• Mentor CRA’s on monitoring, internal procedures, protocol-specific procedures, therapeutic area, and query resolution• Communicate effectively with investigators and the project team, providing a concise message regarding project expectations, status updates, and cross-functional team responsibilities• Perform source document verification of CRFs according to SOPs and study specific requirements• Ensure appropriate reporting of adverse events by investigators according to GCP and SOPs• Train on-site team, including the investigator and other site personnel, in proper conduct of clinical studies• Monitor SAE reporting and request primary and follow-up information according to SOP• Review protocol violations with the investigator and ensure site(s) take corrective actions to ensure future compliance• Responsible for the reconciliation of drug accountability records at sites• Responsible for the reconciliation of all regulatory documents at sites• Document study site progress and escalate issues/concerns to the project team in a timely manner. Address study site issues/concerns with the investigator and offer resolution strategies, documenting follow-up activities and outcomes• Maintain familiarity with FDA regulations and ICH/GCP guidelines as well as company SOPs • Provide accurate and timely monitoring reports in accordance with Study Monitoring Plan• Participate in clinical study team meetings• Assist Data Management in the resolution of data queries• Ensure availability of all study supplies at sites and participate in other tasks as needed

Home Based Out Of San Diego, Ca

• Monitor multiple investigational sites in accordance with State and Federal Regulations, Good Clinical Practices and Standard Operating Procedures for a phase III 3 study of an investigational product for Goucher’s Disease.• Independently schedule and prioritize workload to meet project deadlines for 3 protocols at one time.• Mentor CRA’s on monitoring, internal procedures, protocol-specific procedures, therapeutic area, and query resolution• Communicate effectively with investigators and the project team, providing a concise message regarding project expectations, status updates, and cross-functional team responsibilities• Perform source document verification of CRFs according to SOPs and study specific requirements• Ensure appropriate reporting of adverse events by investigators according to GCP and SOPs• Train on-site team, including the investigator and other site personnel, in proper conduct of clinical studies• Monitor SAE reporting and request primary and follow-up information according to SOP• Review protocol violations with the investigator and ensure site(s) take corrective actions to ensure future compliance• Responsible for the reconciliation of drug accountability records at sites• Responsible for the reconciliation of all regulatory documents at sites• Document study site progress and escalate issues/concerns to the project team in a timely manner. Address study site issues/concerns with the investigator and offer resolution strategies, documenting follow-up activities and outcomes• Maintain familiarity with FDA regulations and ICH/GCP guidelines as well as company SOPs • Provide accurate and timely monitoring reports in accordance with Study Monitoring Plan• Participate in clinical study team meetings• Assist Data Management in the resolution of data queries• Ensure availability of all study supplies at sites and participate in other tasks as needed

• Responsible for monitoring at investigator sites for GCP compliance according to PharmaNet SOP’s and/or client guidelines for a phase IIb and phase III studies in chronic low back pain and chronic kidney disease• Audit Trial Master file to ensure compliance with SOP’s and all regulatory requirements• Generate study specific documentation including monitoring trip reports, telephone contact reports, and site correspondence• Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites• Prepare and process Serious Adverse Event (SAE) reports, according to plan• Resolve queries of CRF data with study site personnel on a daily basis as well as any other questions site may have• Maintain screening and enrollment data in excel tracking spreadsheet• Ensure all outstanding issues are followed until resolution

Warrington, Pa

• Responsible for the unblinded monitoring of 26 U.S. sites for pediatric respiratory trial• Trained site personnel on unblinded procedures at site initiation visit• Review site pharmacy regulatory binder for completeness• Ensure study is conducted according to protocol, GCP and ICH Guidelines• Complete unblinded monitoring trip reports, follow-up letters and expense reports in a timely manner• Review unblinded monitoring reports for ex-US sites • Monitor unblinded portion of electronic Case Report Form• Maintain screening and enrollment tracking systems in excel and electronic data capture (EDC)• Create and present PowerPoint presentations for study training• Train site personnel on EDC system• Assist in clinical supply shipment requests for US and ex-US sites• Participate in project team meetings and provide status updates on responsibilities for study• Compose newsletter for study to be distributed to all participating sites

Warrington, Pa

• Coordinated Medical Science Liaison (MSL) team activities in cooperation with the Vice President of Academic and Medical Affairs• Responsible for the operational and organizational support for MSL training and deployment • Provided accurate and on time management of MSL expense reports• Managed reference library, including all company-wide research requests • Provided operational management of meeting activities such as a “Cyber Café” at major conferences, including the Pediatric Academic Society Congress, the Pediatric Pharmacy Advocacy Group Congress, and Hot Topics in Neonatology• Provided planning, management and operational support, including poster production, for all conference exhibits created by Discovery Labs since 2008 • Managed abstract, poster and manuscript reviews• Collaborated and directly involved with all company departments • Performed unblinded monitoring for 5 U.S. sites

Norristown, Pa

• Effectively implemented educational pharmaceutical web events in cooperation with Program Development Managers• Assessed project requirements and developed action plans, timelines, and standard operating procedures (SOP) for creating and implementing a web event• Developed effective action plans to ensure the creation and implementation of web room events per client needs • Resolved conflicts and implemented clients’ last-minute change requests during on-going events • Developed enhanced professional communication skills to build relationships and gain rapport with clients

Horsham, Pa

• Scheduled speaking programs for physicians on behalf of Merck for various pharmaceutical drugs and vaccinations• Built and maintained strong relationships with the physicians and drug representatives• Managed numerous local and national physicians’ speaking schedules• Extensive use of Microsoft Office®: proficiency in Microsoft Word® and Excel®