Clinical Trials and Research Administrative Assistant managing daily operations for clinical trials. Coordinating regulatory documentation and maintaining records for compliance at St. Luke's University Health Network.
Responsibilities
Coordinate the daily operation of the Clinical Trials Office (CTO) for department management and staff by providing regulatory and administrative support
Serve as a knowledgeable resource to management, staff, physicians, and the general public by maintaining a comprehensive understanding of CTO operations, clinical research activities, and departmental workflows throughout the network
Maintain department out of office calendar and timekeeping logs for biweekly timecard approvals in payroll system as timekeeper in UKG Dimensions
Responsible for the daily review of the central Clinical Trials Office email inbox and forwarding correspondence received to appropriate team member
Create and maintain research readiness profiles for all CTO staff, investigators, and key personnel including the collection, filing, and maintenance of initial and ongoing institutional research readiness documents
Order and maintain office supplies and files associated with purchases; work with research finance regarding financial records for all costs generated by this role and support general office management related to these areas for each CTO location
Assist, as needed, with preparation, maintenance, tracking, and signature retrieval of essential regulatory documents in accordance with sponsor, regulatory, and institutional requirements and ensure documents are filed and audit ready; serve as SuperUser for department electronic regulatory binder system
Process IND Safety Reports (INDSR) in preparation for review by Principal Investigators, clinical teams, and for IRB submission
Facilitate scheduling of Pre-Study Visits (PSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), Closeout Visits (COV), and ad hoc meetings with study sponsors
Responsible for provisioning access to Epic CareLink and Florence eBinders and manage associated access agreements
Requirements
Bachelor’s degree highly preferred
At least three years administrative assistant experience with proven project management abilities required
Must be proficient in MS Word, Excel, PowerPoint and Electronic Mail
Continued training in new versions of software or new computer systems expected
Benefits
Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development opportunities
Job title
Clinical Trials and Research Administrative Assistant
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