Oncology Study Delivery Associate

1 month ago

Greater Toronto Area, Canada ICON Strategic Solutions Full time

Study Delivery Associate (Clinical Study Administrator)

Responsibilities:

  • 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 AstraZeneca 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 Canadian 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


Qualifications:

  • University degree in Health Science, or a related field (an equivalent combination of education, training, and work experience may be considered)
  • Two years experience in Clinical Research or related industry
  • Understanding of Good Clinical Practices/International Committee on Harmonization principles
  • Strong social and interpersonal skills (written and oral). You will be confident speaking to Health Care Professionals.
  • You are able to influence without authority
  • You work effectively both independently and in a team environment
  • You are 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) d using multiple computer systems
  • Being bilingual in French would be considered an asset.

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