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Study Start-Up Administrator

3 months ago

Wilmington, United States ICON Strategic Solutions Full time

*Hybrid position - 3 days in office in Wilmington, DE; 2 days remote*

The Clinical Study Administrator (CSA) assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.


What you will be doing:

  • You approve sites for drug shipment
  • You prepare, execute, track, collect, review and assess clinical documents and ensure their completeness according to regulatory guidelines.
  • You assist external investigational site staff with the accurate and timely completion of ethics and regulatory documents in accordance with the regulatory and GCP guidelines.
  • You review the study scope and design, to provide input into the site level activation and risk mitigation plan and give to ongoing study/site level problem solving throughout the study
  • You support the study lead, by reviewing and contributing to the development and preparation of all study/site level documents as required (for example: Study Management Agreements, delegation of responsibility, Clinical Study Agreements, etc.)
  • You aid in the study regulatory and ethics submission process
  • You ensure audit readiness, by conducting quality checks of SMF documents according to the study Quality Control Plan
  • You plan and actively collate the appendices for the CS Report
  • You develop training material and train site personnel, local study team, research monitors, etc., on study-specific clinical supply and documentation matters (as needed)
  • You are part of the vendor selection and management process where appropriate
  • You set-up, populate, update and accurately maintain information in sponsor clinical systems (e.g. Clinical Trial Management system, eRoom, study web pages, payment application, etc)
  • You input and review payment terms and fee schedule of the Clinical Study Agreement.
  • You review, assess, approve and process payments associated with Agreements, to be in line with the terms of the agreement and financial guidelines
  • You set up and maintain payment terms within the appropriate systems.
  • You review, analyze and resolving payment discrepancies and queries
  • You will lead non-drug supplies, by developing, inputting into, sourcing, ordering, initiating the shipment, tracking, reviewing stock level, and approving materials for destruction
  • You handle import shipping approvals
  • You prepare and execute Statement of Work (SOW) with vendor for local drug management
  • You collaborate with Global Investigational Product Supplies units to ensure precise delivery of clinical drug supplies
  • You communicate with global study teams and local regulatory contacts, to assess US requirements for comparator and/or rescue medication, and source from local providers if required
  • You review, discuss, and communicate packaging and labelling requirements, as defined by the protocol, with vendors
  • You are responsible for the notification, investigation and resolution of product quality complaints


You Are:

  • Minimum Bachelor's degree in Health Science, or a related field is required
  • Minimum two (2) years experience in Clinical Research experience from a CRO or Pharmaceutical company
  • Able to work from Wilmington, DE office at least 3 days a week (2 days in home office)
  • At least 2 years experience working with Regulatory documents
  • Experience working with multiple vendors
  • Understanding of Good Clinical Practices/International Committee on Harmonization principles
  • Strong social and interpersonal skills (written and oral)
  • Confident speaking to Health Care Professionals
  • Able to influence without authority
  • Work effectively both independently and in a team environment
  • Self-motivated and able to display autonomy and initiative
  • You apply a strong attention to detail
  • You seek multiple demands/projects simultaneously
  • Effective time management skills
  • Your passion lies in customer service
  • You have good knowledge of MS Office (Word, Excel, PowerPoint) using multiple computer systems