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Clinical Trial Associate

1 month ago

Newcastle, New South Wales, Australia Pharmiweb Full time
Clinical Trial Associate Job Description

As a Clinical Trial Associate at Pharmiweb, you will be part of a dynamic team responsible for the feasibility and execution of clinical trials. Your primary focus will be on managing documents, logistical, and administrative tasks related to trial feasibility, start-up, execution, and close-out.

Key Responsibilities:

  • Manage all trial-related documents, including those related to trial feasibility, start-up, execution, and close-out.
  • Ensure compliance with Good Clinical Practice (GCP), Health Care Compliance requirements (HCC), and local regulatory requirements.
  • Partner with Clinical Trial Managers and CRA's to ensure overall site management while performing trial-related activities for assigned protocols.
  • Support the protocol-specific training process, manage forms used to track, administer, and document completion of protocol-specific training.
  • Ensure study-related activities are compliant with Global Development SOPs, policies, code of Good Clinical Practice (GCP), Health Care Compliance requirements (HCC), and local regulatory requirements.
  • Filing and maintenance of training materials in the Clinical Trial Learning & Development Training Library and the Trial Master File System at the direction of the Therapeutic Area (TA) Lead(s).

Deliverables:

  • Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, etc.
  • Provides the following deliverables: tracks progress of the clinical trial, manages study data, budget, investigational products, mailings, and correspondence and other relevant tasks in support of the CTM and CRA.
  • Maintains trial, country, and site level protocol information in trial management systems, including but not limited to relevant systems to ensure appropriate safety update distribution.
  • Ensures current versions of the required trial documents, trial-related materials, and supplies are provided to the investigational site(s) within required timeframes.
  • Collects and files all documents throughout the trial and post-trial (GCO) or protocol-specific training-related documents (CTL&D). Uses appropriate systems to ensure file completeness at designated study milestones. Coordinates archiving of paper study relevant documents/files.
  • Ensures audit and inspection readiness.
  • Provide process improvement suggestions if applicable.
  • Negotiates site-requested changes to the confidential disclosure agreement; checks investigators and IEC/IRBs against exclusion databases, IEC/IRB registrations, and alerts as applicable; and other relevant tasks in support of study feasibility and site assessments.
  • Collects/prepares documents required for study, such as start-up/submission to the IEC/IRB and HA, in support of the CTM/CRA where applicable.
  • Collects and tracks financial disclosure information at appropriate timepoints in accordance with procedural documents.
  • Prepares study files for investigational sites and co-ordinates the development of associated documents and review them for completeness and accuracy.
  • Provides updates to study-specific internal data repositories to ensure availability of trial documents to the study team.
  • If requested, manage study budget including Affiliate spend, vendor management (including reconciliation of invoices and final budget), liaising with Accounts Payable as necessary.

Requirements:

  • Degree in the life sciences.
  • Minimum of 1-2 years of previous proven CTA experience in a CRO or Pharmaceutical environment.

What ICON Can Offer You:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work-life balance opportunities for you and your family.

Benefits Examples:

  • Various annual leave entitlements.
  • A range of health insurance offerings to suit you and your family's needs.
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
  • Life assurance.
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.