Manage the release, follow-up and tracking of the Full Regulatory Package (FPP), Amendments, Investigator Brochures, and Informed Consents etc.; that are required to initiative the site and/or require an IRB Approval. Work directly with Central IRB to acquire EC approval for Final Protocol, Amendments, ICFs, and Patient Diaries/Questionnaires, etc.
Manage Clinical Trial Management System (CTMS) data entry and regulatory document management lifecycle of Trial Master File (TMF) study documents at the country, site and patient level with strict adherence to ICH, GCP and FDA regulations as applicable
As knowledge expert of data and systems, provide support to both the Field Monitoring and Project Management Organizations, pertinent to the administration of CTMS and TMF data, quality, distribution and reporting. Such asProvide trial site setup and personnel updates in global clinical planning and tracking database (IMPACT)Track screening activities, create and maintain the Master Investigator lists for all clinical trials during the entire site selection and approval processGenerate performance metrics for potential Investigators and study start up average time for sitesProvide IMPACT support for Clinical Research Associates, Regional Associate Directors, and Clinical Study Managers to address questions/problems on host systemRun reports on a regular basis; analyzing and solving issues that would prevent timely roll-up of milestone event dates for the US
Assist in maintaining TMF (hard and electronic versions), Safety Notifications, Amendments and site personnel contact information within the scope of processing/scanning, quality review and compliance, archiving and tracking. Raise alerts where current status of data quality or performance is at risk to noncompliance
Assist in managing the quality and compliance of CTMS and TMF through use of reports/tools including CREDI, SharePoint, CTMS, site nomination tools, performance metric tool, and dashboards. Perform periodic regulatory document QC and reconciliation activities of CREDI, to ensure document quality (legibility, naming conventions etc.) standards are maintained for the client's eTMF documents
Serve as the primary point of contact/liaison with Field Monitoring Operations, and global Drug Regulatory Affairs (DRA); pertinent to the administration of VDR/RDR and eTMF setup during study start-up and changes to Principal Investigator or 1572
Support production of comprehensive business reports, data extracts and tools to improve and maintain CTMS data quality and operations performance utilizing Excel, PowerPoint, graphing and systems skills
Support IT and web-based system (SharePoint) projects around automation of reports or development of tools to aid/drive process improvement as appropriate
Perform extra assignments beyond assigned regular responsibilities as assigned by Manager
What you need to have:
Bachelor s degree, preferably in a life science, mathematics/statistics, computer science/information technology
Fluent English (oral and written)
1-3 years experience or equivalent competencies in clinical research including a working knowledge of clinical/regulatory development process; study start-up experience preferred
Knowledge of GCP/ICH guidelines and FDA regulations related to regulatory document collection
Good understanding of TMF document types and the ability to distinguish and segment these documents,
Experience with document management repository systems including workflows, scanning and imaging
Proven strong Microsoft Office skills (i.e. Excel, PowerPoint)
Proven ability to meet timelines and manage work independently by working unilaterally or within teams
Detail oriented with superior organization and documentation skills
Knowledge of Process Improvement Methodology preferred.
Ability to multi-task and prioritize multiple high-priority projects
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status
Associated topics: alcohol test, intern, lab, lab tech, lab technician, quality control, research, research associate, routine care, sample collection
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.