St. Luke's University Health Network

Clinical Trials and Research Administrative Assistant

St. Luke's University Health Network

full-time

Posted on:

Location Type: Hybrid

Location: Allentown • Pennsylvania • United States

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About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
project managementregulatory document preparationtimekeepingresearch readiness documentationIND Safety Reports processing
Soft Skills
organizational skillscommunication skillsinterpersonal skillsadministrative support
Certifications
Bachelor’s degree