Overview
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.
Responsibilities
Your responsibilities include:
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
Your 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.
Benefits of Working in ICON:revious administrative experience preferably in the medical/ life science field
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career – both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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Posted Date 3 days ago (10/22/2022 10:58 AM)
ID 2022-96441
Location : Location Canada-ON-
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