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.
·Performs sitequalification, site initiation, interim monitoring, site management activities andclose-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/orGood Pharmacoepidemiology Practice (GPP) and protocol compliance.Uses judgment and experience to evaluateoverall performance of site and site staff and to provide recommendations regardingsite-specific actions; 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.
·Verifies the process ofobtaining informed consent has been adequately performed and documented foreach subject/patient, as required/appropriate. 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.
·Per the ClinicalMonitoring/Site Management Plan (CMP/SMP):
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
·May performinvestigational product (IP) inventory, reconciliation and reviews storage andsecurity. Verifies the IP has been dispensed and administered to subjects/patientsaccording to the protocol. 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.
·Routinely reviews theInvestigator Site File (ISF) for accuracy, timeliness and completeness.Reconciles contents of the ISF with the Trial Master File (TMF). Ensures theinvestigator/physician site is aware of the requirement of archiving essentialdocuments in accordance with local guidelines and regulations.
·Documentsactivities via confirmation letters, follow-up letters, trip reports,communication logs, and other required project documents as per SOPs and ClinicalMonitoring Plan/Site Management Plan.Supports subject/patient recruitment, retention and awarenessstrategies.Enters data into trackingsystems as required to track all observations, ongoing status and assigned actionitems to resolution.
·For assignedactivities, understands project scope, budgets, and timelines; managessite-level activities / communication to ensure project objectives,deliverables and timelines are met.Mustbe able to quickly adapt to changing priorities to achieve goals /targets.
·May act as primaryliaison with study site personnel, or in collaboration with Central MonitoringAssociate.Ensures all assigned sitesand project-specific site team members are trained and compliant withapplicable requirements.
·Prepares for andattends Investigator Meetings and/or sponsor face to face meetings.Participates in global clinical monitoring/projectstaff meetings (inclusive of Sponsor representation, as applicable) and attendsclinical training sessions according to the project specific requirements.
·Provides guidance atthe site and project level towards audit readiness standards and supportspreparation for audit and required follow-up actions.
·Maintainsa working knowledge of ICH/GCP Guidelines or other applicable guidance,relevant regulations, and company SOPs/processes; completes assigned trainingas required.
·ForReal World Late Phase, the CRA II will use the business card title of SiteManagement Associate II.Additionalresponsibilities include:
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
·Bachelor’sdegree or RN in a related field or equivalent combination of education,training and experience
·Knowledgeof Good Clinical Practice/ICH Guidelines and other applicable regulatoryrequirements
·Mustdemonstrate good computer skills and be able to embrace new technologies
·Excellentcommunication, presentation and interpersonal skills
·Abilityto manage required travel of up to 75% on a regular basis