The Clinical ResearchAssociate II (CRA II) will perform monitoring and site management activitiesfor Phase I-IV clinical research projects to assess the progress of clinicalprojects at assigned investigative / physician sites (either on site or remotely)and to ensure clinical projects are conducted, recorded, and reported inaccordance with the protocol, Company and Sponsor standard operating procedures(SOPs), ICH-GCP and / or all applicable local and federal regulatoryrequirements.
Performs all tasksroutinely and independently, seeking guidance as needed.
immediately communicates / escalates serious issues to theproject team and develops action plans.Maintainsa working knowledge of ICH / GCP Guidelines or other applicable guidance,relevant regulations, and company SOPs / processes.
Demonstrates diligence inprotecting the confidentiality of each subject / patient. Assesses factors thatmight affect subject / patient’s safety and clinical data integrity at aninvestigator / physician site such as protocol deviation / violations andpharmacovigilance issues.
oAssesses site processes
oConducts Source Document Review of appropriate site source documents andmedical records
oVerifies required clinical data entered in the case report form (CRF) isaccurate and complete
oApplies query resolution techniques remotely and on site, and providesguidance to site staff as necessary, driving query resolution to closure withinagreed timelines
oUtilizes available hardware and software to support the effectiveconduct of the clinical study data review and capture
oVerifies site compliance with electronic data capture requirements
Verifies issues or risks associated with blinded orrandomized information related to IP. Applies knowledge of GCP / localregulations and organizational procedures to ensure IP is appropriately(re)labelled, imported and released / returned.
Ensures theinvestigator / physician site is aware of the requirement of archiving essentialdocuments in accordance with local guidelines and regulations.
Supports subject / patient recruitment, retention and awarenessstrategies.Enters data into trackingsystems as required to track all observations, ongoing status and assigned actionitems to resolution.
Mustbe able to quickly adapt to changing priorities to achieve goals / targets.
completes assigned trainingas required.
oSitesupport throughout the study lifecycle from site identification through close-out
oKnowledgeof local requirements for real world late phase study designs
oChartabstraction activities and data collection
oCollaborationwith Sponsor affiliates, medical science liaisons and local country staff
oThe SMAII may be requested to train junior staff
oIdentifyand communicate out of scope activities to Lead CRA / Project Manager
oProactivelysuggest potential sites based on local knowledge of treatment patterns, patientadvocacy and Health Care Provider (HCP) associations