The Senior Clinical Research Associate II (SCRA II)will perform monitoring and site management activities for Phase I-IV clinicalresearch projects to assess the progress of clinical projects at assignedinvestigative / physician sites (either on site or remotely) and to ensureclinical projects are conducted, recorded, and reported in accordance with theprotocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP,and all applicable local and federal regulatory requirements.
Performs all tasks routinely andindependently.Mentors and / or trains, aswell as may assume line management responsibilities for less experiencedemployees.
May assume clinical functional leadership tasks as assigned, actingas Lead CRA for a project.
immediately communicates / escalates seriousissues to the project team and develops action plans.Maintains a working knowledge of ICH / GCPGuidelines or other applicable guidance, relevant regulations, and companySOPs / 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 via review of site source documents and medical records
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 action itemsto resolution.
Must be able to quickly adapt to changing priorities to achieve goals / targets.
This could include participationin business development proposals and / or defense meetings.
oSitesupport throughout the study lifecycle from site identification throughclose-out
oKnowledgeof local requirements for real world late phase study designs
oChartabstraction activities and data collection
oAsrequired, collaborate and build relationship with Sponsor and other 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.
oIdentifyoperational efficiencies and process improvements
oDevelopstudy and country level informed consent forms
oCollaboratewith RWLP Regulatory team to ensure updated regulatory information is appliedand shared
oParticipatein bid defense meetings
oProvideinput into Requests for Proposals (RFPs), scope and budgeting.Develop site management strategy.
oParticipate in Case Report Form design andedit check development.