philadelphia, PA30+ days ago
Process and ship blood, urine and tissue as required per trialConduct initiation, monitoring and closeout visits with sponsors and/or CROsEnsure proper screening and enrollment of all study participants, including administering informed consent and confirming subject study eligibility prior to participation Ensure proper reporting of serious and non-serious adverse events to the Sponsor and all applicable institutional or study related committees and personnel (e.g., IRB, DSMC, DSMB/Medical Monitor) according to applicable regulations and policiesCoordinate the administration of the investigational product and study related medications including obtaining orders, scheduling administration dates, administration of investigational and study related medications (as applicable), monitoring subjects for post-administration adverse events or reactionsManage scheduling and coordination of subject study specified treatment, follow-up visits and proceduresMeet with Principal Investigator routinely to discuss study related issues and to ensure completion of study related procedures (e.g., determination of causality for adverse events, deviation/exception requests)Manage collection of data from source documents pertaining to study visits and transcribe to case report form, including concomitant medications and adverse eventsEnsure preparation of study related document templates (e.g., visit guides, source document templates), subject study binders, regulatory binders (hard and electronic version), patient list (enrollment log) for study start upEnsure preparation of all required study related documents for submission to all applicable PENN institutional committees for review and approval to start trial (e.g., IRB, CTSRMC)Assist with protocol development to ensure logistical feasibility of all study related procedures and study work-flowOther duties and responsibilities as assigned. Oversee study preparation and blood sample processing and analysisDatabase management and analysisOrdering and stocking supplies, maintaining equipmentEducate patients and family membersPromote good clinical practice in the conduct of clinical investigations, included possessing an in-depth knowledge of the federal regulations and guidance documents for the conduct of clinical studies and human subject protectionOther duties and responsibilities as assignedCRC-APrepare and process all Institutional Review Board (IRB)through the IRB and other regulatory groups as appropriate including initial submissions, amendments, continuing reviews, adverse events and serious adverse eventsCoordinate, organize and maintain all documentation required by sponsor or CRO (case report forms, source documentation, study and regulatory binders, subject binders)Assist in the coordination of Phase I-IV clinical trialsParticipate in the conduct of study audits by sponsors, CRO''s, the FDA and other entities as required.