The Clinical Trial Associate assists in the coordination and administration of the study activities from the start up to execution and close out.
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
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
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
- Willingness to be office-based in Wilmington, DE (with flexibility to WFH two days per week)
Benefits of Working in ICON: previous 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.
