Christine Jerome

Senior Director of Quality Assurance and Education @Sidney Kimmel Comprehensive Cancer Center At Jefferson

Philadelphia, PA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

May 2016 — Present

Senior Director of Quality Assurance and Education @Sidney Kimmel Comprehensive Cancer Center At Jefferson

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Ensure that the clinical trials conducted at the Sidney Kimmel Cancer Center (SKCC) locations are being conducted according to FDA regulations, ICH-GCP and CTMB guidelines -Conduct internal auditing and monitoring of Investigator Initiated, NCTN/ETCTN and Pharmaceutical trials -Coordinate on-site Sponsor, ETCTN, NCTN audits and FDA inspections -Manage and coordinate the Data and Safety Monitoring Committee -Participate in the orientation of new SKCC staff -Provide training to SKCC employees -Develop and revise standard operating procedures (SOPs) for the SKCC -Ensure adherence to the SKCC CRO SOPs and the protocols -Chair the protocol feasibility committee -Represent the SKCC on the Jefferson Research Compliance Committee

EDUCATION

2014 — 2018

Temple University

Masters of Science, Regulatory Affairs and Quality Assurance

1996 — 2000

Salisbury University

Bachelor of Science (BS), Biology, General

1996 — 2000

University of Maryland Eastern Shore

Bachelor of Science (BS), Marine and Environmental Science

SKILLS

Cancer ResearchHealthcare Information TechnologyHospitalsU.s. Food and Drug Administration (Fda)Quality AssuranceClinical ResearchCase Report FormsProtocol DevelopmentSopClinical MonitoringHealthcare Information Technology (Hit)PowerpointFdaClinical Data ManagementMicrosoft ExcelEmrManagementProtocolHealthcare ManagementElectronic Medical Record (Emr)Regulatory AffairsAuditingIch-GcpClinical Site ManagementHealthcarePublic HealthSop DevelopmentOncologyStandard Operating Procedure (Sop)VisioClinical TrialsGood Clinical Practice (Gcp)

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