Michelle Hirsch Email and Phone Number

• Perform all duties of a CRA as listed in job title below, serving as the primary contact with individual investigative sites that conduct clinical research for PPD• Track enrollment status reports to ensure study stays on track to meet enrollment goals• Track study-specific status reports to ensure all required information regarding site issues, deviations, and CRF status were kept current by the monitoring team• Conduct routine performance assessment visits for less experienced CRAs to ensure monitoring meets PPD standards• Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues• As an approved accompanier, conduct sign-off authorization visits for new CRAs on pre-study, initiation, interim and close-out visits• Provide direct support to the Clinical Team Manager by assisting with monitoring visit report review and other managerial tasks• Perform study-specific training with project team• Develop study-specific monitoring tools and forms for use by monitoring team to assist in efficient review of study data• Perform Serious Adverse Event reconciliation and work with sponsor, study sites and CRAs to resolve discrepancies• Review outstanding data reports and work with CRAs to ensure data collection is met per contractual guidelines• Assist sponsor, study sites, and CRAs with audit preparation/responses and quality issues

Provide site support and management from a regional location while ensuring site data entry, and the resolution of queries. Manage assigned sites by performing regular telephone contact, ensuring site compliance, and performing remote regulatory binder review while adhering to GCP/ICH Guidelines, SOPs, and all other applicable regulatory requirements. Primary contact for the support of Investigational Sites. Provide training to all Investigational Site staff, including the Principal Investigator. Ensure that sites have proper regulatory documentation, IRB approval, and updated Informed Consent documentation. Work to close out sites and study while complying with close out visit procedures. Provides support for electronic CRF data entry, and query response. Report to project team, client, and site personnel any findings noted during telephone contacts, or site visits. Significant issues noted must be reported to appropriate personnel immediately. Complete quarterly newsletter to support site communication. Enforce Serious Adverse Event compliance and respond to all SAE queries from data management team and/or the safety department. Manage time, finances and client deliverables in accordance with the contract, while ensuring financial profitability.

• Source verified data against multiple data sources• Transcribed source document data onto CRFs• Worked in Express EDC System• Query creation• Query resolution

Coordinated daily acquisitions, receiving and distribution of material resources for the unit. Participated in planning and implementing cost effective changes in material systems through inventory management and alternative purchasing. Established and maintained a stock inventory of all supplies on the unit. Performed inventory counts using a hand held computer and submitted data. Interfaced with Vendors. Acted as a unit liaison in value analysis process. Reviewed all shift reports for supply/inventory issues and trends, and resolved problems. Participated in the budget process and achieve targets set for supply budget. Maintained cost savings of 15% annually. Justified overages. Annually identified material resource trends and made recommendations based on data, adjusted supply quotas and equipment inventory as needed. Prepared requisitions for repairs. Weekly accounted for all unit equipment (beds, computers on wheels, telemetry packs and tablets). Created newsletter in Microsoft Publisher. Supported administrative assistant when needed. Answered unit phones, and transferred calls to nurses’ zone phones. Reported critical values from the laboratory to nurses.

Gave and documented direct patient care. Assisted patients to complete activities of daily living, maintain mobility, and assure safety. Obtained EKG’s demonstrating and maintaining proper technique, skill and competence. Applied telemetry monitoring including assuring completion of requisition, transmission to monitoring station and assuring proper placement of leads and battery intact. Obtained blood specimens on all patients, maintaining proper technique, skill and competency. Ensured correct procedure was followed while labeling and sending specimen to Lab. Inspected skin integrity and reporting findings to RN. Electronically documented vital signs, intake and output.

Monitored and disseminated information regarding study protocols. Reviewed source documents and case report forms as well as regulatory, informed consent, investigational product, and clinical supply accountability documents. Ensured immediate reporting of any serious adverse events related to study projects. Updated and maintained internal training records, SOPs, calendars, and time and expense reporting. Maintained tracking list of all site issues identified and assured accuracy of Site Monitoring Visit Reports prior to sponsor review. Supported sites with query process. Trained all Investigational staff. Conducted co-monitoring visits and advised project team on task status completion and site activity as needed. Created monthly newsletter in Publisher and distributed to staff, clinical sites and Sponsor

Recruited study sites based on Sponsor directive. Oversaw and managed IRB submission process (both local and central IRBs). Prepared, negotiated changes to, and accurately tracked recruitment, agreement/budget, and other essential documents in accordance with specified plans, guidelines, and time lines. Assembled and distributed regulatory binders. Managed sites through the investigational product shipment approval process. Oversaw and communicated site initiation activities to project teams. Assisted in identifying and implementing best practices and continuous improvement initiatives