Study Delivery Associate (Hybrid - Mississauga)

Study Delivery Associate (Clinical Study Administrator)

Responsibilities:

• You review, analyze and resolving payment discrepancies and queries
• You set up and maintain payment terms within the appropriate systems.
• You prepare and execute Statement of Work (SOW) with vendor for local drug management
• You handle import shipping approvals
• 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 approve sites for drug shipment
• You prepare, execute, track, collect, review and assess clinical documents and ensure their completeness according to regulatory guidelines.
• You ensure audit readiness, by conducting quality checks of SMF documents according to the study Quality Control Plan
• You review, discuss, and communicate packaging and labelling requirements, as defined by the protocol, with vendors
• 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 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 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 plan and actively collate the appendices for the CS Report
• You review, assess, approve and process payments associated with Agreements, to be in line with the terms of the agreement and financial guidelines
• You aid in the study regulatory and ethics submission process
• You collaborate with Global Investigational Product Supplies units to ensure precise delivery of clinical drug supplies
• You input and review payment terms and fee schedule of the Clinical Study Agreement.
• You are responsible for the notification, investigation and resolution of product quality complaints
• 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 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 develop training material and train site personnel, local study team, research monitors, etc., on study-specific clinical supply and documentation matters (as needed)

Qualifications:

• You have good knowledge of MS Office (Word, Excel, PowerPoint) d using multiple computer systems
• You seek multiple demands/projects simultaneously
• You apply a strong attention to detail
• Effective time management skills
• You are self-motivated and able to display autonomy and initiative
• Being bilingual in French would be considered an asset.
• University degree in Health Science, or a related field (an equivalent combination of education, training, and work experience may be considered)
• You work effectively both independently and in a team environment
• 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
• Your passion lies in customer service