Start-up Associate (Clinical Trial Associate) - Sydney

Fortrea; Sydney; Vor Ort; AUD 60.000 - 80.000; Vollzeit

Zusammenfassung

Fortrea in Sydney is seeking a Start-up Associate (Clinical Trial Associate) to serve as primary contact with investigative sites during study maintenance and startup activities, ensuring essential regulatory documents are collected and submissions are made on time.

You will support senior staff with ICH/GCP compliance, adapt consent forms for country requirements, and liaise with internal teams and vendors to prepare regulatory authority submissions.

Qualifikationen

• University/College degree (life science preferred) or equivalent in related field.
• 0–2 years of experience in clinical trials or regulatory roles.
• Basic understanding of ICH, RA, IRB/IEC and related guidelines.

Aufgaben

• Develop awareness of regulatory legislation and practice with support from senior staff.
• Assist senior staff to compile, submit, and obtain approvals for regulatory submissions to IRB/IEC/Third body/Regulatory Authority.
• Liaise with internal and external vendors for regulatory submissions and quality review.
• Review final submission documents for accuracy and compliance.
• Prepare and organize submission-related communications within Fortrea.
• Escalate study issues in a timely manner and support management as needed.

Kenntnisse

Regulatory knowledge

Documentation control

IRB familiarity

Site liaison

Ausbildung

University/College degree (life science preferred)

Jobbeschreibung

Start-up Associate (Clinical Trial Associate) - Sydney

Primary contact with investigative sites during study maintenance and -when assigned-, site startup activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within the timelines agreed with project management and Site Readiness team. Develop awareness of regulatory legislation, guidance, and practice in the assigned countries with the support from senior staff.

Summary of Responsibilities:

• Develop awareness of regulatory legislation, guidance, and practice in the assigned countries with the support from senior staff.
• Assist senior staff to compile, prepare, submit, and obtain approval of the submission documents to IRB/IEC/Third body/Regulatory Authority in accordance with local requirements.
• Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).
• Perform a review of final submission documents as applicable.
• Organize communication related to the submissions/outcomes within Fortrea as applicable.
• Escalate study issues appropriately and in a timely fashion.
• Perform other duties as assigned by management depending upon country and situational requirements with proper supervision (if applicable).

In Country specific tasks (Global):

• Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
• Collect and track all the necessary documents required and perform a quality review, formatting, and compilation of the final documents for effective and compliant site activation and maintenance.
• Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines.
• Update study documents when there are changes in study personnel/study amendments.
• Ensure high quality documents are filed and systems are updated on an ongoing and timely basis, making Fortrea ready for an audit at any time.
• Update status reports, applicable logs, and tracking systems as applicable for the projects with input provided by senior staff.
• With guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements.
• May support / assist the contract negotiation process under supervision of an experienced colleague or line manager.
• Proactively identifying and escalating to Submission Leads any risk to meeting deliverables.
• Notify the Submissions Lead of hours identified as Out-of-Scope or over burn with the support of more senior specialists.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology).

Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

Minimum 0 – 2 + years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.

Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines

Demonstrated basic understanding of the clinical trial process.

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